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Dietary weight loss and exercise interventions effects on quality of life in overweight/obese postmenopausal… Imayama, Ikuyo; Alfano, Catherine M; Kong, Angela; Foster-Schubert, Karen E; Bain, Carolyn E; Xiao, Liren; Duggan, Catherine; Wang, Ching-Yun; Campbell, Kristin L; Blackburn, George L; McTiernan, Anne Oct 25, 2011

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RESEARCH Open AccessDietary weight loss and exercise interventionseffects on quality of life in overweight/obesepostmenopausal women: a randomizedcontrolled trialIkuyo Imayama1, Catherine M Alfano2, Angela Kong3, Karen E Foster-Schubert4, Carolyn E Bain1, Liren Xiao1,Catherine Duggan1, Ching-Yun Wang1,5, Kristin L Campbell6, George L Blackburn7 and Anne McTiernan1,4,8*AbstractBackground: Although lifestyle interventions targeting multiple lifestyle behaviors are more effective in preventingunhealthy weight gain and chronic diseases than intervening on a single behavior, few studies have comparedindividual and combined effects of diet and/or exercise interventions on health-related quality of life (HRQOL). Inaddition, the mechanisms of how these lifestyle interventions affect HRQOL are unknown. The primary aim of thisstudy was to examine the individual and combined effects of dietary weight loss and/or exercise interventions onHRQOL and psychosocial factors (depression, anxiety, stress, social support). The secondary aim was to investigatepredictors of changes in HRQOL.Methods: This study was a randomized controlled trial. Overweight/obese postmenopausal women were randomlyassigned to 12 months of dietary weight loss (n = 118), moderate-to-vigorous aerobic exercise (225 minutes/week,n = 117), combined diet and exercise (n = 117), or control (n = 87). Demographic, health and anthropometricinformation, aerobic fitness, HRQOL (SF-36), stress (Perceived Stress Scale), depression [Brief Symptom Inventory(BSI)-18], anxiety (BSI-18) and social support (Medical Outcome Study Social Support Survey) were assessed atbaseline and 12 months. The 12-month changes in HRQOL and psychosocial factors were compared using analysisof covariance, adjusting for baseline scores. Multiple regression was used to assess predictors of changes in HRQOL.Results: Twelve-month changes in HRQOL and psychosocial factors differed by intervention group. The combineddiet + exercise group improved 4 aspects of HRQOL (physical functioning, role-physical, vitality, and mental health),and stress (p ≤ 0.01 vs. controls). The diet group increased vitality score (p < 0.01 vs. control), while HRQOL did notchange differently in the exercise group compared with controls. However, regardless of intervention group,weight loss predicted increased physical functioning, role-physical, vitality, and mental health, while increasedaerobic fitness predicted improved physical functioning. Positive changes in depression, stress, and social supportwere independently associated with increased HRQOL, after adjusting for changes in weight and aerobic fitness.Conclusions: A combined diet and exercise intervention has positive effects on HRQOL and psychological health,which may be greater than that from exercise or diet alone. Improvements in weight, aerobic fitness andpsychosocial factors may mediate intervention effects on HRQOL.Keywords: health-related quality of life, exercise, dietary weight loss, postmenopausal women* Correspondence: amctiern@fhcrc.org1Public Health Sciences Division, Fred Hutchison Cancer Research Center,Seattle, WA, USAFull list of author information is available at the end of the articleImayama et al. International Journal of Behavioral Nutrition and Physical Activity 2011, 8:118http://www.ijbnpa.org/content/8/1/118© 2011 Imayama et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the CreativeCommons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, andreproduction in any medium, provided the original work is properly cited.BackgroundNearly two-thirds of US adults are overweight or obese [1].These individuals are at increased risk for a variety ofchronic diseases including metabolic disease, heart disease,cancer, and psychosocial disorders [2], which may signifi-cantly reduce health-related quality of life (HRQOL). Areview of 8 studies examining HROQL among womenaged over 55 years old concluded that postmenopausalwomen, especially those with BMI greater than 30 kg/m2,have lower HRQOL in physical functioning, energy, andvitality compared with normal-weight women [3].Lifestyle modification including dietary weight loss orphysical activity has been shown to improve HRQOL[4-6]. Despite the numbers of studies reporting positiveeffects of lifestyle modification on HRQOL, limited studieshave investigated possible mechanisms of change inHRQOL. Further, the optimal lifestyle prescription forimproving HRQOL has not been established [7].Increasing evidence suggests that the combination ofdiet and exercise may be superior to diet or exercisealone with respect to reducing weight [8,9], improvinglipid profile [10,11] and preventing type 2 diabetes [12].However, the few intervention studies that compared theeffects of dietary weight loss and/or exercise interven-tions on HRQOL have shown mixed results [13-15].Among 76 patients with type 2 diabetes, diet+exerciseand diet-only intervention groups significantly improvedin a general quality of life measure [13]. In 316 olderadults with osteoarthritis, individuals assigned to a diet+exercise intervention improved HRQOL (physical func-tioning, general health, role-physical, body pain, andsocial functioning) compared with controls [14]. Among157 healthy men, no differences in change in HRQOLwere observed among men randomized to diet+exercise,diet-only, exercise-only, or control groups [15].Despite numerous exercise and dietary weight loss inter-ventions reporting positive changes in HRQOL, themechanisms behind how exercise and dietary weight lossprograms improve HRQOL are not clear. While someintervention studies have shown that weight loss is asso-ciated with improved HRQOL [16,17], others have shownthat people improve HRQOL without anthropometricchanges [18,19].The primary aim of this study was to examine the indivi-dual and combined effects of dietary weight loss and exer-cise interventions on HRQOL. Defining the individual andcombined effects of diet and exercise interventions onHRQOL will help inform researchers, practitioners andpolicy makers on optimal lifestyle prescriptions forimproving HRQOL. The secondary aim was to explorephysical and psychosocial factors associated with changesin HRQOL during the intervention. The findings wouldprovide information to explain potential mechanisms ofhow diet and exercise interventions affect HRQOL.MethodsThe Nutrition and Exercise for Women (NEW) trial was a12-month, randomized controlled trial conducted at theFred Hutchinson Cancer Research Center, Seattle, WAfrom 2005 to 2009. Participants were recruited from thegreater Seattle, WA area though mass mailing and mediaplacements from 2005 to 2008, and 439 were enrolled inthe study (Figure 1). The study inclusion criteria included:age 50-75 years old; body mass index (BMI) ≥ 25.0 kg/m2(if Asian-American ≥ 23.0 kg/m2); < 100 minutes per weekof moderate or vigorous intensity physical activity; post-menopausal; not taking hormone replacement therapy forthe past 3 months; no history of breast cancer, heart dis-ease, diabetes mellitus, or other serious medical condi-tions; fasting glucose < 126 mg/dL; currently not smoking;alcohol intake of fewer than 2 drinks per day; able toattend diet/exercise sessions at the intervention site; andnormal exercise tolerance test.Women were randomized to: (1) dietary weight losswith a goal of 10% weight reduction (N = 118), (2) moder-ate-to-vigorous intensity aerobic exercise for 45 minutes/day, 5 days/week (N = 117), (3) combined exercise anddiet (N = 117), and control groups (N = 87). Study staffperformed randomization through a computer programdeveloped by the study statistician. Randomization wasblocked on BMI (< 30.0 kg/m2 or ≥ 30.0 kg/m2) and race/ethnicity (White, Black, and others). In addition, to achievea proportionally smaller number of women assigned to thecontrol group, a permuted blocks randomization withblocks of 4 was used, where in the control assignment wasrandomly eliminated from each block with a probability ofapproximately 1 in 4. The NEW trial was designed to havesufficient power to detect a difference of 10% change inserum estrone, the primary study outcome, over a 12-month period making three primary pairwise comparisons:diet + exercise vs. exercise; diet + exercise vs. diet; and dietvs. exercise intervention groups. Based on the number ofparticipants who completed the 12-month assessments,we estimate that we have 99.9% power to detect 10 pointschange in the physical functioning scale (HRQOL).All study procedures were reviewed and approved bythe Fred Hutchinson Cancer Research Center Institu-tional Review Board in Seattle, WA, and all participantsprovided signed Informed Consent.InterventionsThe diet group received a reduced calorie weight lossintervention, a modification of the Diabetes PreventionProgram (DPP) lifestyle [20] and Look AHEAD (Actionfor Health in Diabetes) trial [21] interventions with goalsof: total caloric intake of 1200- 2000 kcal/day based onbaseline weight, ≤30% calories from fat, and 10% weightloss within the first 24 weeks with maintenance for therest of intervention period. The diet intervention wasImayama et al. International Journal of Behavioral Nutrition and Physical Activity 2011, 8:118http://www.ijbnpa.org/content/8/1/118Page 2 of 12conducted by dietitians with training in behavior modifi-cation. Participants had individual sessions with the dieti-tians at least twice, then met weekly in small groups(average 5-10 women) until week 24, and afterward com-municated with the dietitians at least twice per montheither via group sessions or via email/phone contact. Thediet intervention involved sessions designed to developstrategies and skills to achieve caloric and weight lossgoals, which included self-monitoring, goal setting, cop-ing strategies, and problem solving. Excluded (n=245) ƒ Did not meet eligibility criteria (n=191) ƒ Declined to participate (n=54) Control  (n=87) Dietary weight loss (n=118) Aerobic exercise  (n=117) Diet + Exercise (n=117) Did not receive intervention as allocated (n=7)  Lost to follow-up (n=4) Withdrew (n=3)    ƒ Dissatisfied with     randomization (n=3) Did not receive intervention as allocated (n=9)  Lost to follow-up (n=5) Withdrew (n=4) ƒ Work/family demands     (n=2) ƒ Medical reasons (n=1) ƒ Relocation (n=1) Did not receive intervention as allocated (n=13)  Lost to follow-up (n=6) Withdrew (n=7) ƒ Dissatisfied with   randomization (n=4)   ƒ Work/family demands         (n=2)  ƒ Medical reasons (n=1) Did not receive intervention as allocated (n=11)   Lost to follow-up (n=5)  Withdrew (n=6) ƒ Medical reasons (n=2)  ƒ Transportation (n=2)       ƒ Work/family demands        (n=1) ƒ Death unrelated to     intervention (n=1) Assessed for eligibility in clinic (n=684) Randomized (n=439) Analyzed (n=117) Analyzed (n=87) Analyzed (n=118) Analyzed (n=116)  Missing baseline questionnaire (n=1) Completed 12-mo assessment (n=80)  ƒ Anthropometry (n=80) ƒ Vo2max (n=73) ƒ Questionnaire (n=76) Completed 12-mo assessment (n=108)  ƒ Anthropometry(n=108) ƒ Vo2max (n=104) ƒ Questionnaire (n=106) Completed 12-mo assessment (n=105)  ƒ Anthropometry(n=103) ƒ Vo2max (n=97) ƒ Questionnaire (n=101) Completed 12-mo assessment (n=106)  ƒ Anthropometry(n=106) ƒ Vo2max (n=96) ƒ Questionnaire (n=99) Attended information session (n=703) Eligible after phone interview (n=929) Mass Mailings sent (n=126 802) Responded to media & Community outreach (n=2 048) Returned interest survey (n=5 621) Figure 1 Flow diagram of the trial.Imayama et al. International Journal of Behavioral Nutrition and Physical Activity 2011, 8:118http://www.ijbnpa.org/content/8/1/118Page 3 of 12The exercise intervention was 45 minutes per day ofmoderate-to-vigorous intensity aerobic exercise, 5 daysper week including 3 exercise physiologist-supervisedsessions per week at the facility. Over the first 8 weeks,participants gradually increased the intensity and dura-tion of exercise training to 70-85% of maximal heartrate (using Polar heart rate monitors, Lake Success, NY)for 45 minutes per session and maintained this levelthereafter.Women in the diet+exercise group received both thereduced-calorie weight loss and exercise interventions.The diet sessions were provided separately for diet+exercise and diet only groups. Although the diet andexercise group used the exercise facility with womenassigned to the exercise-only group, participants wereinstructed not to discuss the diet intervention.Controls were not given an intervention during thetrial, but were offered 4 group diet sessions and 8 weeksof supervised exercise sessions after 12 months’ datacollection.MeasuresInformation on demographics, medication use, anthropo-metrics, aerobic fitness, lifestyle behaviors, psychosocialfactors, and HRQOL were assessed at baseline and 12months. Study staff involved in these assessments wereblinded to randomization. Information on age, race/eth-nicity, education, marital status, and employment werecollected using a standardized questionnaire. Participantswere asked to bring their current prescription and over-the-counter medications to the clinic, and informationon drug name, dose, frequency, and duration of use wereabstracted. Height and weight were measured with astadiometer and digital scale, and BMI was calculated askg/m2. Aerobic fitness was assessed with a maximumgrade treadmill test using the modified branching proto-col [22,23]. Physical activity was measured using an inter-view adapted from the Minnesota Leisure Time PhysicalActivity Questionnaire [24]. Dietary intake was assessedusing the Women’s Health Initiative 120-item food fre-quency questionnaire [25].Psychosocial factors examined included depression,anxiety, perceived stress, and social support. Depressionand anxiety were assessed by the Brief Symptom Inven-tory-18 [26]. Raw scores were calculated and T scoreswere assigned according to the scoring manual [27] withhigher scores indicating more symptoms of depressionand anxiety. Perceived stress was assessed with the Per-ceived Stress Scale [28]; scores ranged from 0 to 4 withlarger scores indicating greater perceived stress. Overallsocial support was assessed by the short version of theMedical Outcomes Study (MOS) Social Support Survey[6,29]. A mean of all item scores was calculated and con-verted to a score ranging from 0 to 100. Higher socialsupport scores suggest greater perception of socialsupport. HRQOL was assessed by the MOS 36-ItemShort-Form Health Survey (SF-36) [30]. Eight subscales(physical functioning, role-physical, bodily pain, vitality,general health, social functioning, role-emotional, andmental health) were calculated, per standard scoring pro-tocol. Scores ranges from 0 to 100 with higher scoresindicating a better state of HRQOL. For the bodily painsubscale, higher scores represent less pain.Statistical analysesWe performed analyses using last observation carriedforward. For comparison, we also performed the analysesusing available data and using multiple imputation. Allrandomized participants were included in the analysesfollowing the intention-to-treat principle. The baselinecharacteristics were compared across the 4 study armsusing analysis of variance (ANOVA) and chi-square tests,as appropriate. T-tests were used to compare differencesin baseline HRQOL and psychosocial factors (depression,anxiety, perceived stress, and social support) by sub-groups defined by baseline characteristics: age (definedby median split as < 57 years vs. ≥ 57 years), ethnicity(non-Hispanic White, others), education (no collegedegree, college degree), employment (employed, unem-ployed), marital status (no partner, married or with part-ner), baseline BMI (25 ≤ BMI < 30, ≥ 30 kg/m2), and useof antidepressants or anxiolytics (no, yes). Baseline char-acteristics that significantly altered HRQOL scores andpsychosocial factors were included as covariates in thesubsequent analyses. We also tested models withoutthese covariates (unadjusted model). The 12-monthchanges in HRQOL were compared among the 4 studyarms using the analysis of covariance (ANCOVA) adjust-ing for baseline scores and covariates identified in theanalysis given above. We used the Bonferroni correctionto adjust for multiple comparisons (P-value = 0.05/3 =0.017 for 3 comparisons).Data for all participants were used in the followinganalyses. For HRQOL subscales which significantly dif-fered across intervention groups, Pearson’s correlationcoefficients were calculated to assess the bivariate asso-ciations between changes in HRQOL and physical andpsychological factors (weight, aerobic fitness, depression,perceived stress and social support). Multiple regressionanalysis was used to assess predictors of HRQOLchange. All analyses were performed with SAS software(version 9.1; SAS Institute, Cary, NC).ResultsBaseline questionnaire data was available from 438 partici-pants. Of the 439 women randomized to the 4 study arms,399 completed physical exams, 370 completed a treadmilltest, and 382 returned the questionnaire at 12 monthsImayama et al. International Journal of Behavioral Nutrition and Physical Activity 2011, 8:118http://www.ijbnpa.org/content/8/1/118Page 4 of 12(Figure 1). There were no differences in baseline HRQOLscore or psychosocial variables (depression, anxiety, per-ceived stress, and social support) between those who com-pleted vs. did not complete the 12-months questionnaire(all p-values > 0.05).Baseline characteristics of study participantsTable 1 displays the baseline characteristics of the studyparticipants. Participants were a mean age of 58 years;mostly non-Hispanic white (85%); and highly educated(65% with college degree). There were no differences inbaseline characteristics among the 4 study arms (all p-values > 0.05). There were no differences in psychosocialfactors and HRQL between the four study arms exceptthe mental health score. The exercise group had highermental health scores compared with diet and controlgroups at baseline (p < 0.05).Intervention effects on weight, aerobic fitness andadherenceThe intervention effects on weight and aerobic fitnessand adherence were reported elsewhere [31]. In brief, thediet, exercise, and diet+exercise groups decreased bodyweight by 7.2 kg over 12 months (percent change frombaseline body weight %ΔDiet = 8.5%; p < 0.01), 2.0 kg (%ΔExercise = 2.4%, p = 0.03), and 8.9 kg (%ΔDiet+Exercise =10.8%, p < 0.01), respectively compared with controls.Approximately half of the participants in the diet groups(diet 41.5%; diet + exercise groups 59.5%) achieved thegoal of 10% weight reduction at 12 months. The exerciseand diet + exercise groups met a mean 80% and 85% ofthe goal of 225 minutes per week of moderate intensityaerobic exercise, respectively. Aerobic fitness increasedby 0.17 L/min and 0.12 L/min, respectively in exerciseand diet+exercise groups (all p < 0.001, vs. control).Baseline HRQOL scores and psychosocial factors stratifiedby subgroupsTable 2 displays mean HRQOL scores at baseline stratifiedby baseline characteristics. Older women (≥ 57 years) hadlower role-physical scores and perceived stress, and highervitality scores compared to younger women (< 57 years;p < 0.05). None of the psychosocial factors and HRQOLscores were different between subgroups defined by ethni-city or education. Employed women had lower social func-tioning than unemployed women (p = 0.02). Women whowere married or with partner reported higher levels ofsocial support (p < 0.05; vs. no partner). Obese womenhad lower physical functioning and role-physical scores(p < 0.05; vs. overweight). Women taking antidepressantsor anxiolytics reported a higher level of bodily pain; lowerphysical functioning, vitality, role-emotional, and mentalhealth scores; and higher levels of depression and anxiety(all p < 0.05).Intervention effects on 8 aspects of HRQOLOverall, the 12-months changes in 4 subscales ofHRQOL differed among the 4 groups: physical function-ing (p < 0.001), role-physical (p < 0.001), vitality (p <0.001), and mental health (p = 0.06) (Table 3). Comparedwith controls, the diet+exercise group increased physicalfunctioning (p < 0.001), role-physical (p < 0.001), vitality(p < 0.001), and mental health scores (p = 0.01) anddecreased bodily pain (p = 0.04). Although both the dietand diet+exercise groups increased vitality, the diet+exer-cise group showed a larger increase than the diet onlygroup (p = 0.04 comparing the two groups). The dietonly group increased vitality (p < 0.001; vs. controls) andmental health (p = 0.05; vs. controls). The exercise groupdid not improve any subscales of HRQOL compared withcontrols.Intervention effects on psychosocial variablesThe 12-month change in perceived stress differed bystudy arm (p = 0.04). The diet+exercise group signifi-cantly decreased perceived stress (-0.55 points) while thecontrol group increased their stress levels (0.32 points)(p = 0.006) (Table 4). Although the overall and pairwisecomparisons among 4 study arms did not reach statisticalsignificance (due to the Bonferroni correction for multi-ple comparison; p ≤0.017 was considered statistically sig-nificant in the pairwise comparision), the diet+exercisegroup reduced depression (ΔDiet+Exercise = -1.7 points, p =0.03; vs. control ΔControl = 0.7 points) and increasedsocial support (ΔDiet+Exercise = 1.0 points, p = 0.05; vs.control ΔControl= -2.8 points).Bivariate correlations between changes in HRQOL andphysical and psychosocial factorsBivariate correlations were examined for 12-monthchanges in HRQOL and factors that significantly changedduring the intervention using combined data of all 4study groups (Table 5). Weight loss was positively asso-ciated with changes in physical functioning (r = 0.28, p <0.001), role-physical (r = 0.18, p < 0.001), vitality (r =0.36, p < 0.001) and mental health scores (r = 0.13, p =0.006). Weight loss was also associated with an improve-ment in depression scores (r = -0.11, p = 0.02). Increasedaerobic fitness was positively associated with physicalfunctioning scores (r = 0.16, p = 0.0007). Decreaseddepression and perceived stress, and improved socialsupport were associated with increases in physical func-tioning, role-physical, vitality and mental health scores(all p < 0.001). Decreased depression was associated withincreased physical functioning (r = -0.21, p < 0.001), role-physical (r = -0.23, p < 0.001), vitality (r = -0.42, p <0.001), and mental health scores (r = -0.55, p < 0.001).Increased stress was inversely associated with physicalfunctioning (r = -0.22, p < 0.001), role-physical (r = -0.20,Imayama et al. International Journal of Behavioral Nutrition and Physical Activity 2011, 8:118http://www.ijbnpa.org/content/8/1/118Page 5 of 12p < 0.001), vitality (r = -0.32, p < 0.001), and mentalhealth scores (r = -0.51, p < 0.001). Increased social sup-port was associated with improved physical functioning(r = 0.24, p < 0.001), role-physical (r = 0.22, p < 0.001),vitality (r = 0.22, p < 0.001), and mental health (r = 0.25,p < 0.001).Predictors of 12-month changes in HRQOLThe 12-month changes in the four subscales of HRQOLthat significantly differed by intervention arm (physicalfunctioning, role-physical, vitality, and mental health)were further examined to identify the predictors ofHRQOL change (Table 6). Change in anxiety levels didnot differ by intervention arm; therefore, it was notincluded in the model [32]. In multiple regression mod-els, the 12-month changes in weight (b = -0.50, p <0.001), aerobic fitness (b = 4.67, p = 0.01), perceivedstress (b = -0.58, p = 0.02), and social support (b = 0.17,p < 0.001) predicted increased physical functioning.Reduced weight (b = -0.67, p = 0.001) and depression(b = -0.50, p = 0.001) and improved social support (b =0.24, p = 0.01) predicted increased role-physical score.Reduced weight (b = -0.74, p < 0.001), depression (b =-0.42, p < 0.001) and perceived stress (b = -0.79, p =0.004) were associated with improved vitality. Weightloss (b = -0.15, p = 0.04) and decreases in depressionTable 1 Baseline characteristics of study participants stratified by trial armControl Diet Exercise Diet+ExerciseN = 87 N = 118 N = 117 N = 117DemographicsAge (years), mean (SD) 57.4 (4.4) 58.1 (5.9) 58.1 (5.0) 58.0 (4.5)Ethnicity, N (%)Non-Hispanic white 74 (85.1) 101 (85.6) 98 (83.8) 100 (85.5)Education, N (%)College degree 59 (67.8) 76 (64.4) 70 (59.8) 82 (70.1)Marital status a, N (%)Married or with partner 59 (67.8) 79 (67.0) 71 (60.7) 70 (60.3)Employment b, N (%)Employed 72 (97.3) 92 (87.6) 87 (90.6) 94 (91.2)Unemployed 2 (2.7) 13 (12.4) 9 (9.4) 9 (8.7)Anthropometrics, mean (SD)BMI(kg/m2), 30.7 (3.9) 31.0 (3.9) 30.7 (3.7) 31.0 (4.3)Body fat (%) 47.8 (4.5) 47.6 (4.4) 47.9 (4.1) 48.0 (4.6)Waist circumference (cm) 94.3 (11.3) 94.6 (10.2) 95.1 (10.1) 93.7 (9.9)Antidepressants/anxiolytics use, N (%)Yes 29 (33.3) 35 (29.7) 41 (35.0) 44 (37.6)Lifestyle factors, mean (SD)Aerobic fitness (ml/kg/min), 23.1 (4.1) 22.6 (3.8) 22.5 (4.1) 23.5 (4.1)Physical activity (min/week) 23.8 (41.2) 33.6 (45.5) 37.7 (43.7) 33.6 (44.7)Calorie intake (kcal/day) c 1988 (669) 1884 (661) 1986 (589) 1890 (638)Psychosocial factors, mean (SD)Depression 48.0 (9.0) 49.4 (9.8) 48.3 (9.4) 48.3 (8.7)Anxiety 45.3 (7.0) 44.9 (6.8) 43.5 (6.1) 44.2 (6.8)Perceived stress 3.71 (2.64) 3.47 (2.66) 3.43 (2.75) 3.04 (2.35)Social support 81.0 (20.1) 80.0 (19.3) 81.4 (15.9) 81.7 (19.4)Health-related quality of life, mean (SD)Physical functioning 86.8 (11.7) 86.2 (11.0) 87.8 (11.1) 86.7 (12.1)Role-physical 81.6 (30.1) 83.5 (26.8) 82.8 (29.3) 83.5 (25.9)Bodily pain 75.8 (17.2) 76.9 (15.1) 77.8 (16.5) 78.8 (16.8)General health 57.1 (8.0) 55.9 (7.7) 56.9 (6.7) 57.6 (6.4)Vitality 57.4 (16.0) 56.6 (17.7) 60.3 (16.3) 58.7 (18.6)Social functioning 87.8 (18.0) 88.1 (17.1) 91.4 (13.1) 90.8 (13.4)Role-emotional 84.1 (26.9) 82.2 (28.5) 87.5 (25.5) 88.6 (20.1)Mental health 77.1 (13.5) 76.8 (13.1) 81.1 (10.0) 79.1 (12.3)a marital status (n = 438); b employment (n = 378); c calorie intake (n = 427)Imayama et al. International Journal of Behavioral Nutrition and Physical Activity 2011, 8:118http://www.ijbnpa.org/content/8/1/118Page 6 of 12(b = -0.43, p < 0.001) and perceived stress (b = -1.28, p <0.001) predicted positive changes in mental health.We also performed the analyses using available data andusing multiple imputation. There were no substantial dif-ferences between the results on these analyses except forthe relationship between changes in aerobic fitness andthe physical functioning scale. The correlation coefficientbetween 12-month changes in aerobic fitness and the phy-sical functioning scale was significant in the last-observa-tion carried forward and complete case analyses (p < 0.01),while it was non-significant in the multiple imputationanalyses (p = 0.09, data are available on request). There-fore, we presented the results of last observation carriedforward analyses in this paper. The analysis results did notdiffer substantially when the covariates were removedfrom the model (unadjusted model, supplementary tablesare available on request).DiscussionThis study examined the individual and combined effectsof dietary weight loss and/or aerobic exercise interven-tions on HRQOL among sedentary, overweight/obesepostmenopausal women. To our knowledge, this trial isthe first to compare individual and combined effects ofdietary weight loss and exercise intervention on HRQOLin overweight/obese, postmenopausal women withoutmajor medical conditions. We found that the combineddietary weight loss and exercise group improved moreaspects of HRQOL and psychosocial factors (depression,stress and social support) with larger increments com-pared with diet or exercise alone. We also found signifi-cant associations between weight loss, increased aerobicfitness, and improvements in HRQOL and psychologicalfactors, suggesting that these factors may explain, at leastin part, the improved HRQOL observed in the diet andexercise interventions.The combined dietary weight loss and exercise groupimproved more aspects of HRQOL and with larger incre-ments compared with diet or exercise alone. Our findingswere consistent with previous trials in clinical populations,among those with type 2 diabetes [13] or osteoarthritis[14]. The latter trial reported up to a 16.5 point increase inall subscales of SF-36 with a 18-month diet+exercise inter-vention [14], which was greater than the observed changesTable 2 Baseline scores of health-related quality of life (measured by SF-36) and psychosocial factors (depression andanxiety measured by BSI-18, perceived stress measured by the Perceived Stress Scale, social support measured byMOS Social Support Survey), stratified by subgroupsHealth-related quality of life (SF-36) Psychosocial variablesN PF RPc BP GH VT SF REd MH DEP ANX PSS SSDemographicsAge< 57 yrs 210 87.5 86.7† 76.7 57.2 56.1† 88.8 84.0 77.6 49.0 44.6 3.72* 79.2≥ 57 yrs 228 86.3 79.5† 78.1 56.5 60.3† 90.4 87.3 79.6 48.1 44.2 3.09* 82.7EthnicityNon-Hispanic white 372 86.8 83.9 78.1 56.6 58.5 90.1 86.2 78.9 48.4 44.2 3.30 81.4Others 66 87.4 77.7 73.9 58.2 57.2 87.1 83.1 76.9 49.6 45.4 3.89 78.9EducationNo college degree 152 86.8 83.3 76.9 57.3 58.5 87.6 83.1 78.2 48.3 44.5 3.64 79.9College degree 286 86.9 82.8 77.7 56.6 58.2 90.7 87.1 78.8 48.7 44.4 3.26 81.6Employment aEmployed 344 87.2 83.4 77.0 56.7 57.7 88.7* 85.5 77.9 48.7 44.7 3.54 80.1Unemployed 33 84.1 81.8 79.2 56.1 54.8 93.6* 85.9 79.6 47.7 44.1 2.91 83.8Marital status bNo partner 159 86.3 84.7 79.2 56.5 59.1 89.9 85.4 77.8 49.4 44.2 3.50 72.4†Married or with partner 278 87.2 81.9 76.4 57.0 57.8 89.5 85.8 79.1 48.0 44.6 3.33 86.0†AnthropometricsOverweight 209 89.7† 86.3* 79.0 56.8 59.7 90.7 86.7 78.6 48.0 44.2 3.19 82.1Obese 229 84.3† 79.9* 76.1 56.9 57.0 88.6 84.8 78.7 49.0 44.6 3.58 80.0Antidepressants/anxiolyticsuseNo 289 88.1† 83.5 79.2† 57.3 60.5† 90.5 88.4† 80.0† 47.5† 43.8† 3.26 81.2Yes 149 84.5† 81.9 74.1† 56.0 54.1† 88.0 80.5† 76.1† 50.6† 45.6† 3.66 80.6*p < 0.05, †p < 0.01 comparing differences between subgroupsa baseline employment (n = 377), b marital status (n = 437), c Role-physical (n = 437), d Role-emotional (n = 436)PF: physical functioning, RP: role-physical, BP: bodily pain, GH: general health, VT: vitality, SF: social functioning, RE: role-emotional, MH: mental health, DEP:depression, ANX: anxiety, PSS: perceived stress scale, SS: social supportImayama et al. International Journal of Behavioral Nutrition and Physical Activity 2011, 8:118http://www.ijbnpa.org/content/8/1/118Page 7 of 12Table 3 Individual and combined effects of diet and/or exercise intervention on health-related quality of life scores(measured by SF-36)Baseline 12 months ChangesUnadjusted mean (SD) Unadjusted mean (SD) Unadjusted mean Adjusted mean p-value * p-value †Physical functioning < 0.001Control 86.8 (11.7) 84.5 (15.5) -2.3 -2.6 RefDiet 86.2 (11.0) 88.1 (15.9) 1.9 1.2 0.03Exercise 87.8 (11.1) 87.6 (15.0) -0.2 -0.1 0.17Diet + Exercise 86.7 (12.1) 92.4 (11.3) 5.7 5.5 < 0.001 bRole-physical < 0.001Control 81.6 (30.1) 78.7 (32.0) -2.9 -3.7 RefDiet 83.5 (26.8) 82.8 (30.4) -0.7 -0.3 0.36Exercise 82.8 (29.3) 78.7 (32.7) -4.1 -4.1 0.93Diet + Exercise 83.5 (25.9) 92.5 (18.9) 9.0 9.6 < 0.001 bBodily pain 0.12Control 75.8 (17.2) 72.6 (18.2) -3.2 -4.6 RefDiet 76.9 (15.1) 76.8 (21.2) -0.1 -1.1 0.15Exercise 77.8 (16.5) 74.5 (20.7) -3.3 -3.8 0.74Diet + Exercise 78.8 (16.8) 79.1 (17.5) 0.3 0.4 0.04General health 0.57Control 57.1 (8.0) 56.4 (7.1) -0.7 -0.5 RefDiet 55.9 (7.7) 56.9 (7.3) 1.0 0.5 0.24Exercise 56.9 (6.7) 56.4 (7.3) -0.5 -0.5 0.97Diet + Exercise 57.6 (6.4) 56.9 (7.3) -0.7 -0.3 0.81Vitality < 0.001Control 57.4 (16.0) 59.2 (17.9) 1.8 0.4 RefDiet 56.6 (17.7) 65.7 (17.2) 9.1 7.2 < 0.001Exercise 60.3 (16.3) 62.9 (17.6) 2.6 2.8 0.25Diet + Exercise 58.7 (18.6) 70.2 (17.2) 11.5 11.2 < 0.001 aSocial functioning 0.43Control 87.8 (18.0) 86.9 (17.5) -0.9 -2.5 RefDiet 88.1 (17.1) 87.2 (18.6) -0.9 -3.1 0.83Exercise 91.4 (13.1) 88.5 (18.9) -2.9 -4.0 0.58Diet + Exercise 90.8 (13.4) 91.6 (17.0) 0.8 -0.2 0.37Role-emotional 0.09Control 84.1 (26.9) 83.3 (31.8) -0.8 -3.3 RefDiet 82.2 (28.5) 85.6 (27.4) 3.4 -0.8 0.51Exercise 87.5 (25.5) 81.4 (32.5) -6.1 -6.2 0.45Diet + Exercise 88.6 (20.1) 90.3 (22.8) 1.7 2.5 0.13Mental health 0.06Control 77.1 (13.5) 77.3 (14.5) 0.2 -0.8 RefDiet 76.8 (13.1) 80.2 (13.0) 3.4 2.2 0.05Exercise 81.1 (10.0) 81.2 (11.7) 0.1 0.9 0.29Diet + Exercise 79.1 (12.3) 82.3 (12.6) 3.2 3.1 0.01Adjusted mean change indicates adjustment for the baseline health-related quality of life (HRQOL) scores and covariates*p-value comparing 12-month changes in HRQOL vs. control adjusting for the baseline scores and covariates (Physical functioning: baseline BMI, medication use,Role-physical: age, baseline BMI, Bodily pain: medication use, Vitality: age, medication use, Social functioning: employment status, Role-emotional: medication use,Mental health: medication use)†p-value for group effects on 12-month changes in HRQOL adjusting for baseline scores and covariates (Physical functioning: baseline BMI, medication use, Role-physical: age, baseline BMI, Bodily pain: medication use, Vitality: age, medication use, Social functioning: employment status, Role-emotional: medication use,Mental health: medication use)ap-value< 0.05 vs. diet group, bp-value< 0.01 vs. diet groupImayama et al. International Journal of Behavioral Nutrition and Physical Activity 2011, 8:118http://www.ijbnpa.org/content/8/1/118Page 8 of 12in our sample (5-11 points). This may be caused by differ-ences in the study sample, as the observed increase inHRQOL scores among our combined diet+exercise groupwas consistent with previous weight loss trials in generalpopulations [4,17]. In a 6-month weight loss trial (low cal-orie diet and aerobic exercise) among 298 obese women(age 50-75), women lost 9.4% of baseline weight andincreased physical functioning and vitality scores by 6 and8 points, respectively [17]. Another 6-month weight losstrial in 144 overweight/obese adults reported a meanweight loss of 5.6 kg and 2 to 11-point improvements in 8subscales of SF-36 [4].In contrast to a number of studies reporting positiveeffects of exercise on HRQOL, we did not find signifi-cant improvements in any aspects of HRQOL in womenrandomized to the exercise-only group. It is possiblethat our participants had high baseline HRQOL whichcould have caused a ceiling effect. Preference for type ofexercise could also have affected the results. Courneyaet al. found that participants who preferred resistantTable 4 Individual and combined effects of diet and/or exercise intervention on psychosocial factors (depression andanxiety measured by BSI-18, perceived stress measured by the Perceived Stress Scale, social support measured byMOS Social Support Survey)Baseline 12 months ChangesUnadjusted mean (SD) Unadjusted mean (SD) Unadjusted mean Adjusted mean p-value * p-value †Depression 0.12Control 48.0 (9.0) 48.4 (9.6) 0.4 0.7 RefDiet 49.4 (9.8) 47.8 (8.7) -1.6 -0.5 0.31Exercise 48.3 (9.4) 48.1 (9.8) -0.2 0.2 0.68Diet + Exercise 48.3 (8.7) 46.2 (8.2) -2.1 -1.7 0.03Anxiety 0.41Control 45.3 (7.0) 45.3 (8.7) 0.0 0.6 RefDiet 44.9 (6.8) 43.8 (7.3) -1.1 -0.6 0.17Exercise 43.5 (6.1) 43.0 (6.9) -0.5 -0.7 0.14Diet + Exercise 44.2 (6.8) 43.5 (6.4) -0.7 -0.6 0.15Perceived stress 0.04Control 3.71 (2.64) 3.89 (2.75) 0.18 0.32 RefDiet 3.47 (2.66) 3.51 (2.65) 0.04 0.08 0.44Exercise 3.43 (2.75) 3.35 (2.84) -0.08 -0.06 0.23Diet + Exercise 3.04 (2.35) 2.66 (2.27) -0.38 -0.55 0.006Social support 0.11Control 81.0 (20.1) 78.5 (20.8) -2.5 -2.8 RefDiet 80.0 (19.3) 79.4 (20.5) -0.6 -1.1 0.38Exercise 81.4 (15.9) 78.6 (20.8) -2.8 -2.9 0.97Diet + Exercise 81.7 (19.4) 82.9 (18.6) 1.2 1.0 0.05Adjusted means are changes in psychological factors adjusted for baseline scores and covariates (e.g., age, baseline BMI, marital status, anxiolytics andantidepressants use)*p-value comparing 12-month changes in psychosocial factors vs. control adjusting for the baseline scores and covariates (Depression: medication use, Anxiety:medication use, Stress: age, Social support: marital status)†p-value for group effects on 12-month changes in psychosocial factors adjusting for baseline scores and covariates (Depression: medication use, Anxiety:medication use, Stress: age, Social support: marital status)Table 5 Bivariate correlations between 12-month changes in health-related quality of life (measured by SF-36) andpotential predictorsΔ Weight Δ Aerobic fitness Δ Depression Δ Perceived stress Δ Social supportR p r p R p r p r pΔ Weight — — -0.02 0.64 0.11 0.02 0.07 0.17 -0.02 0.66Δ Aerobic fitness -0.02 0.64 — — -0.0006 0.99 -0.08 0.08 0.02 0.61Δ Physical functioning -0.28 < 0.001 0.16 < 0.001 -0.21 < 0.001 -0.22 < 0.001 0.24 < 0.001Δ Role-physical -0.18 < 0.001 0.05 0.26 -0.23 < 0.001 -0.20 < 0.001 0.22 < 0.001Δ Vitality -0.36 < 0.001 0.06 0.22 -0.42 < 0.001 -0.32 < 0.001 0.22 < 0.001Δ Mental health -0.13 0.006 0.04 0.43 -0.55 < 0.001 -0.51 < 0.001 0.25 < 0.001Imayama et al. International Journal of Behavioral Nutrition and Physical Activity 2011, 8:118http://www.ijbnpa.org/content/8/1/118Page 9 of 12training showed greater increase in HRQOL whenassigned to resistant training group compared withthose assigned to aerobic exercise or control groups[33]. Our participants might have preferred to beassigned to a group other than the exercise-only group,which could have resulted in minimal changes inHRQOL.The combined diet+exercise intervention also improvedpsychosocial factors (depression, stress, and social sup-port), while there were no effects on these factors in thediet or exercise alone groups. Although we are not awareof studies comparing these psychological outcomes inindividual vs. combined diet and exercise interventions,lifestyle modification programs involving diet and exercisehave been shown to improve psychological health. A 12-month intensive lifestyle intervention program of the LookAHEAD (Action for Health in Diabetes) Trial, mediatedthrough weight loss (mean 8.8 kg weight loss among inter-vention group) and aerobic fitness, improved depression in4223 overweight adults with type 2 diabetes [18]. A cardiacrehabilitation program reduced stress, which was asso-ciated with weight loss and improved aerobic fitness [34].Our finding that the combined diet+exercise groupimproved psychological factors is consistent with thesestudies, but the reasons for the improvements are notclear. We did not find any significant correlations betweenweight loss or aerobic fitness with these psychosocial fac-tors except for a correlation between weight loss andreduced depression. Future studies are recommended toinvestigate mechanisms by which lifestyle interventionsmay improve psychological health.Positive changes in depression and stress were signifi-cantly associated with 4 subscales of HRQOL, whichremained significant after adjusting for changes in weightand aerobic fitness. Studies have shown that psychologicaldisorders affect various aspects of HRQOL. An analysis of11,242 outpatients in the U.S. showed that individuals whoare depressed have lower physical functioning, role-physi-cal and social functioning compared with non-depressedindividuals [35]. Another study has shown that increaseddepressive symptoms were associated with decline in all 8aspects of SF-36 among female patients with remittedmajor depression disorder [36]. Our study confirmed thatpsychological conditions have a significant impact onHRQOL and that a lifestyle behavioral change of a dietand exercise in combination, is a potential method toimprove psychological health.Improved aerobic fitness was an independent predictorof 12-month changes in physical functioning. Consistentwith our findings, Ross et al. found that changes in BMIand aerobic fitness independently explained a change inphysical functioning score, and that improved aerobic fit-ness had independent effects beyond BMI change only inphysical functioning scale among 8 subscales of SF-36 ina 6-month lifestyle intervention among obese women[17]. An analysis from the Look AHEAD trial found thatboth weight loss and increased aerobic fitness mediatedthe intervention effects on physical composite scores[18]. In our previous 12-month exercise trial in 173 post-menopausal women, we found that a change in aerobicfitness was associated with a change in physical function-ing but not with changes in either mental health or gen-eral health [6].Weight loss in the present study was associated withimprovements in both physical and mental aspects ofHRQOL. A 12-month follow-up of a 6-month lifestyleintervention found that individuals who continued to loseweight during the follow-up period showed improvedvitality and general health of SF-36 and that weight losswas associated with improvements in these aspects of SF-36 among 508 postmenopausal women [37]. Our findingsconfirmed that obesity is a risk factor for reduced HRQOLand that weight loss can improve both physical and mentalaspects of HRQOL.Previous studies have shown an important role of psy-chosocial factors on explaining how exercise impactsquality of life [38-41]. In multiple sclerosis patients,depression, social support, self-efficacy and fatiguemediated effects of exercise on quality of life [41].Greater social support was associated with stronger exer-cise self-efficacy in older adults in another study [42].Exercise self-efficacy mediated the exercise effect onTable 6 Predictors of 12-month changes in health-related quality of life (measured by SF-36)12-month changes in HRQOLPhysical functioning Role-physical Vitality Mental healthb P b P b P b PChange in weight -0.50 < 0.001 -0.67 0.001 -0.74 < 0.001 -0.15 0.04Change in aerobic fitness 4.67 0.01 3.65 0.37 0.93 0.65 -0.15 0.91Change in depression -0.12 0.10 -0.50 0.001 -0.42 < 0.001 -0.43 < 0.001Change in perceived stress -0.58 0.02 -0.66 0.24 -0.79 0.004 -1.28 < 0.001Change in social support 0.17 < 0.001 0.24 0.01 0.08 0.07 0.04 0.18The regression models were adjusted for group assignment, baseline health-related quality of life (HRQOL) scores, and covariates (Physical functioning: baselineBMI, medication use, Role-physical: age, baseline BMI, Vitality: age, medication use, Mental health: medication use)Imayama et al. International Journal of Behavioral Nutrition and Physical Activity 2011, 8:118http://www.ijbnpa.org/content/8/1/118Page 10 of 12mental and physical aspects of HRQOL in older women[40]. Higher exercise self-efficacy was associated withgreater physical power score, a combined score of aerobicfitness and five items from the Senior Fitness Test [43]among older adults [44]. It is possible that the observedassociations of weight loss and improved aerobic fitnesswith HRQOL in our study could be mediated throughincrease in exercise self-efficacy. Future studies may ben-efit from testing psychosocial predictors of quality of lifeincluding self-efficacy to further determine the mechan-ism of how interventions affect HRQOL.The strengths of this trial include its large sample size;randomized controlled design; three intervention armsallowing direct comparisons of individual and combinedexercise and diet groups to each other and controls; excel-lent adherence to intervention prescription; low rate ofdrop-outs (9%); and use of validated measures of HRQOLand psychosocial factors. In particular, direct comparisonbetween combined diet+exercise and diet or exercisealone allowed us to understand the individual and com-bined contribution of these lifestyle behaviors on HRQOL.This study is limited by some factors that should be keptin mind when interpreting the results. Our sample con-sisted primarily of non-Hispanic White women with ahigh education level on average. Hence, our findings maynot be generalizable to men, or women in other ethnicgroups or with different education levels. Another limita-tion is the relatively high HRQOL scores among our sam-ple. Even though we found significant effects on severalaspects of HRQOL, the analysis may have suffered from aceiling effect. Based on these limitations, future studies areneeded to test the effects of these dietary weight loss andexercise interventions in other populations such as womenof other race/ethnicity groups or in men.ConclusionsOur findings suggest that the combination of dietaryweight loss and exercise may have a larger beneficial effecton HRQOL compared with dietary weight loss or exercisealone. Weight loss and improvements in aerobic fitnessand psychosocial factors (depression, stress, and socialsupport) were predictors of increased HRQOL, suggestingthat these factors could mediate the intervention effectson HRQOL.AbbreviationsANCOVA: analysis of covariance; ANOVA: analysis of variance; BMI: body massindex; BSI: Brief Symptom Inventory; DPP: Diabetes Prevention Program;HRQOL: health related quality of life; Look AHEAD: Action for health inDiabetes; MOS: Medical Outcome Study Social Support Survey; SF-36:Medical Outcomes Study 36-Item Short-Form Health Survey.AcknowledgementsThe Nutrition and Exercise for Women (NEW) trial was supported by R01CA105204-01A1 from the National Cancer Institute (NCI). While working onthe trial, CMA was employed at the Ohio State University, and located toNCI following completion of her effort on the NEW trial. AK was supportedby NCI R25CA094880 at the time of this study and is currently supported byNCI 2R25CA057699. KEF is supported by 5KL2RR025015-03 from NationalCenter for Research Resources (NCRR), a component of the National Instituteof Health (NIH) and NIH Roadmap for Medical Research.Author details1Public Health Sciences Division, Fred Hutchison Cancer Research Center,Seattle, WA, USA. 2Office of Cancer Survivorship, National Cancer Institute,National Institutes of Health, Bethesda, MD, USA. 3Cancer Education andCareer Development Program, University of Illinois at Chicago, Chicago, IL,USA. 4Department of Medicine, School of Medicine, University ofWashington, Seattle, WA, USA. 5Department of Biostatistics, School of PublicHealth, University of Washington, Seattle, WA, USA. 6Department of PhysicalTherapy, University of British Columbia, Vancouver, BC, Canada. 7Departmentof Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School,Boston, MA, USA. 8Department of Epidemiology, School of Public Health,University of Washington, Seattle, WA, USA.Authors’ contributionsII conducted data analyses, interpreted the results and drafted themanuscript. CMA interpreted the results and drafted the manuscript. AK andCEB acquired the data. LX performed analysis. GLB designed the study. AMdesigned the study, acquired the data, interpreted the results, and draftedthe manuscript. All authors have revised and approved the manuscript.Competing interestsThe authors declare that they have no competing interests.Received: 11 January 2011 Accepted: 25 October 2011Published: 25 October 2011References1. Flegal KM, Carroll MD, Ogden CL, Curtin LR: Prevalence and trends inobesity among US adults, 1999-2008. JAMA 2010, 303(3):235-241.2. Avenell A, Broom J, Brown TJ, Poobalan A, Aucott L, Stearns SC, Smith WC,Jung RT, Campbell MK, Grant AM: Systematic review of the long-termeffects and economic consequences of treatments for obesity andimplications for health improvement. Health Technol Assess 2004,8(21):1-182, iii-iv.3. Jones GL, Sutton A: Quality of life in obese postmenopausal women.Menopause Int 2008, 14(1):26-32.4. 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