Effects of a mindfulness-based weight loss intervention in adults with obesity: A randomized clinical trial.
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ABSTRACT: Objective
To determine whether adding mindfulness-based eating and stress management practices to a diet-exercise program improves weight loss and metabolic syndrome components.Methods
In this study 194 adults with obesity were randomized to a 5.5-month program with or without mindfulness training and identical diet-exercise guidelines. Intention-to-treat analyses with multiple imputation were used for missing data. The primary outcome was 18-month weight change.Results
Estimated effects comparing the mindfulness to control arm favored the mindfulness arm in (a) weight loss at 12 months, -1.9 kg (95% CI: -4.5, 0.8; P = 0.17), and 18 months, -1.7 kg (95% CI: -4.7, 1.2; P = 0.24), though not statistically significant; (b) changes in fasting glucose at 12 months, -3.1 mg/dl (95% CI: -6.3, 0.1; P = 0.06), and 18 months, -4.1 mg/dl (95% CI: -7.3, -0.9; P = 0.01); and (c) changes in triglyceride/HDL ratio at 12 months, -0.57 (95% CI: -0.95, -0.18; P = 0.004), and 18 months, -0.36 (95% CI: -0.74, 0.03; P = 0.07). Estimates for other metabolic risk factors were not statistically significant, including waist circumference, blood pressure, and C-reactive protein.Conclusions
Mindfulness enhancements to a diet-exercise program did not show substantial weight loss benefit but may promote long-term improvement in some aspects of metabolic health in obesity that requires further study.
SUBMITTER: Daubenmier J
PROVIDER: S-EPMC4898945 | biostudies-literature | 2016 Apr
REPOSITORIES: biostudies-literature
Publications
Effects of a mindfulness-based weight loss intervention in adults with obesity: A randomized clinical trial.
Daubenmier Jennifer J Moran Patricia J PJ Kristeller Jean J Acree Michael M Bacchetti Peter P Kemeny Margaret E ME Dallman Mary M Lustig Robert H RH Grunfeld Carl C Nixon Douglas F DF Milush Jeffrey M JM Goldman Veronica V Laraia Barbara B Laugero Kevin D KD Woodhouse Leslie L Epel Elissa S ES Hecht Frederick M FM
Obesity (Silver Spring, Md.) 20160309 4
<h4>Objective</h4>To determine whether adding mindfulness-based eating and stress management practices to a diet-exercise program improves weight loss and metabolic syndrome components.<h4>Methods</h4>In this study 194 adults with obesity were randomized to a 5.5-month program with or without mindfulness training and identical diet-exercise guidelines. Intention-to-treat analyses with multiple imputation were used for missing data. The primary outcome was 18-month weight change.<h4>Results</h4>E ...[more]
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Project description:ObjectiveMindfulness-based interventions have been found to reduce psychological and physiological stress reactivity. In obesity, however, stress reactivity is complex, with studies showing both exaggerated and blunted physiological responses to stressors. A nuanced view of stress reactivity is the "challenge and threat" framework, which defines adaptive and maladaptive patterns of psychophysiological stress reactivity. We hypothesized that mindfulness training would facilitate increased challenge-related appraisals, emotions, and cardiovascular reactivity, including sympathetic nervous system activation paired with increased cardiac output (CO) and reduced total peripheral resistance (TPR) compared to a control group, which would exhibit an increased threat pattern of psychophysiological reactivity to repeated stressors.MethodsAdults (N=194) with obesity were randomized to a 5.5-month mindfulness-based weight loss intervention or an active control condition with identical diet-exercise guidelines. Participants were assessed at baseline and 4.5 months later using the Trier Social Stress Task. Electrocardiogram, impedance cardiography, and blood pressure were acquired at rest and during the speech and verbal arithmetic tasks to assess pre-ejection period (PEP), CO, and TPR reactivity.ResultsMindfulness participants showed significantly greater maintenance of challenge-related emotions and cardiovascular reactivity patterns (higher CO and lower TPR) from pre to post-intervention compared to control participants, but groups did not differ in PEP. Findings were independent of changes in body mass index.ConclusionsMindfulness training may increase the ability to maintain a positive outlook and mount adaptive cardiovascular responses to repeated stressors among persons with obesity though findings need to be replicated in other populations and using other forms of mindfulness interventions.
| S-EPMC7138245 | biostudies-literature
Project description:Background and objectiveSleep disturbance is a common problem among adults with obesity. Mindfulness interventions have been shown to improve sleep quality in various populations but have not been investigated in adults with obesity. The aim of this study was to compare the effects of a mindfulness-based weight-loss intervention with an active control on self-reported sleep quality among adults with obesity.MethodThis study was a secondary analysis of a randomized controlled trial and included 194 adults with a body mass index in the range 30-45 kg/m2. The treatment intervention included mindfulness-based eating and stress-management practices, and the active control intervention included training in progressive muscle relaxation (PMR). Both groups received identical diet and exercise guidelines in 17 group sessions conducted over 5.5 months that were matched for time, attention, and social support. The primary outcome of this analysis was between-group change in self-reported sleep quality, which was assessed using the Pittsburgh Sleep Quality Index (PSQI) global score at baseline and at 6, 12, and 18 months.ResultsBetween-group differences in mean PSQI change scores in the mindfulness group (n = 100) compared to the control group (n = 94) were -0.27 (-0.68, 1.22; p = 0.58) at 6 months, -0.57 (-0.35, 1.50; p = 0.22) at 12 months, and -0.50 (-0.53, 1.53; p = 0.34) at 18 months, all in the direction of more sleep improvement in the mindfulness group but none reaching statistical significance. In the mindfulness group, average weekly minutes of meditation practice time was associated with improved sleep quality from baseline to 6 months.ConclusionsNo statistically significant evidence was found that a weight-loss program that incorporates mindfulness improves self-reported sleep quality compared to a control diet/exercise intervention that included PMR. Within the mindfulness group, average weekly minutes of mindfulness practice was associated with improved sleep quality.
| S-EPMC5359641 | biostudies-literature
Project description:BackgroundThe high proportion of people with overweight and obesity has become a worldwide problem in recent decades, mainly due to health consequences, such as cardiovascular diseases, neoplasia, and type 2 diabetes mellitus. Regarding effective countermeasures, the digitization of health services offers numerous potentials, which, however, have not yet been sufficiently evaluated. Web-based health programs are becoming increasingly interactive and can provide individuals with effective long-term weight management support.ObjectiveThe purpose of this randomized controlled clinical trial was to evaluate the effectiveness of an interactive web-based weight loss program on anthropometric, cardiometabolic, and behavioral variables and to compare it with a noninteractive web-based weight loss program.MethodsThe randomized controlled trial included people who were aged between 18 and 65 years (mean 48.92, SD 11.17 years) and had a BMI of 27.5 to 34.9 kg/m2 (mean 30.71, SD 2.13 kg/m2). Participants (n=153) were assigned to either (1) an interactive and fully automated web-based health program (intervention) or (2) a noninteractive web-based health program (control). The intervention program focused on dietary energy density and allowed for dietary documentation with appropriate feedback on energy density and nutrients. The control group only received information on weight loss and energy density, but the website did not contain interactive content. Examinations were performed at baseline (t0), at the end of the 12-week intervention (t1), and at 6 months (t2) and 12 months (t3) thereafter. The primary outcome was body weight. The secondary outcomes were cardiometabolic variables as well as dietary and physical activity behaviors. Robust linear mixed models were used to evaluate the primary and secondary outcomes.ResultsThe intervention group showed significant improvements in anthropometric variables, such as body weight (P=.004), waist circumference (P=.002), and fat mass (P=.02), compared with the control group over the course of the study. The mean weight loss after the 12-month follow-up was 4.18 kg (4.7%) in the intervention group versus 1.29 kg (1.5%) in the control group compared with the initial weight. The results of the nutritional analysis showed that the energy density concept was significantly better implemented in the intervention group. Significant differences in cardiometabolic variables were not detected between the 2 groups.ConclusionsThe interactive web-based health program was effective in reducing body weight and improving body composition in adults with overweight and obesity. However, these improvements were not associated with relevant changes in cardiometabolic variables, although it should be noted that the study population was predominantly metabolically healthy.Trial registrationGerman Clinical Trials Register DRKS00020249; https://drks.de/search/en/trial/DRKS00020249.International registered report identifier (irrid)RR2-10.3390/ijerph19031393.
| S-EPMC10337343 | biostudies-literature
Project description:CONTEXT:Given the obesity epidemic, effective but resource-efficient weight loss treatments are needed. Stepped-treatment approaches customize interventions based on milestone completion and can be more effective while costing less to administer than conventional treatment approaches. OBJECTIVE:To determine whether a stepped-care weight loss intervention (STEP) compared with a standard behavioral weight loss intervention (SBWI) would result in greater weight loss. DESIGN, SETTING, AND PARTICIPANTS:A randomized clinical trial of 363 overweight and obese adults (body mass index: 25-<40; age: 18-55 years, 33% nonwhite, and 83% female) who were randomized to SBWI (n = 165) or STEP (n = 198) at 2 universities affiliated with academic medical centers in the United States (Step-Up Study). Participants were enrolled between May 2008 and February 2010 and data collection was completed by September 2011. INTERVENTIONS:All participants were placed on a low-calorie diet, prescribed increases in physical activity, and attended group counseling sessions ranging from weekly to monthly during an 18-month period. The SBWI group was assigned to a fixed program. Counseling frequency, type, and weight loss strategies could be modified every 3 months for the STEP group in response to observed weight loss as it related to weight loss goals. MAIN OUTCOME MEASURE:Mean change in weight over 18 months. Additional outcomes included resting heart rate and blood pressure, waist circumference, body composition, fitness, physical activity, dietary intake, and cost of the program. RESULTS:Of the 363 participants randomized, 260 (71.6%) provided a measure of mean change in weight over 18 months. The 18-month intervention resulted in weight decreasing from 93.1 kg (95% CI, 91.0 to 95.2 kg) to 85.6 kg (95% CI, 83.4 to 87.7 kg) (P < .001) in the SBWI group and from 92.7 kg (95% CI, 90.8 to 94.6 kg) to 86.4 kg (95% CI, 84.5 to 88.4 kg) in the STEP group (P < .001). The percentage change in weight from baseline to 18 months was -8.1% (95% CI, -9.4% to -6.9%) in the SBWI group (P < .001) compared with -6.9% (95% CI, -8.0% to -5.8%) in the STEP group (P < .001). Although the between-group difference in 18-month weight loss was not statistically different (-1.3 kg [95% CI, -2.8 to 0.2 kg]; P = .09), there was a significant group × time interaction effect (P = .03). The cost per participant was $1357 (95% CI, $1272 to $1442) for the SBWI group vs $785 (95% CI, $739 to $830) for the STEP group (P < .001). Both groups had significant and comparable improvements in resting heart rate, blood pressure level, and fitness. CONCLUSIONS:Among overweight and obese adults, the use of SBWI resulted in a greater mean weight loss than STEP over 18 months. Compared with SBWI, STEP resulted in clinically meaningful weight loss that cost less to implement. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT00714168.
| S-EPMC4132634 | biostudies-literature
Project description:ImportanceLifestyle interventions for weight loss are difficult to implement in clinical practice. Self-managed mobile health implementations without or with added support after unsuccessful weight loss attempts could offer effective population-level obesity management.ObjectiveTo test whether a wireless feedback system (WFS) yields noninferior weight loss vs WFS plus telephone coaching and whether participants who do not respond to initial treatment achieve greater weight loss with more vs less vigorous step-up interventions.Design, setting, and participantsIn this noninferiority randomized trial, 400 adults aged 18 to 60 years with a body mass index of 27 to 45 were randomized in a 1:1 ratio to undergo 3 months of treatment initially with WFS or WFS plus coaching at a US academic medical center between June 2017 and March 2021. Participants attaining suboptimal weight loss were rerandomized to undergo modest or vigorous step-up intervention.InterventionsThe WFS included a Wi-Fi activity tracker and scale transmitting data to a smartphone app to provide daily feedback on progress in lifestyle change and weight loss, and WFS plus coaching added 12 weekly 10- to 15-minute supportive coaching calls delivered by bachelor's degree-level health promotionists viewing participants' self-monitoring data on a dashboard; step-up interventions included supportive messaging via mobile device screen notifications (app-based screen alerts) without or with coaching or powdered meal replacement. Participants and staff were unblinded and outcome assessors were blinded to treatment randomization.Main outcomes and measuresThe primary outcome was the between-group difference in 6-month weight change, with the noninferiority margin defined as a difference in weight change of -2.5 kg; secondary outcomes included between-group differences for all participants in weight change at 3 and 12 months and between-group 6-month weight change difference among nonresponders exposed to modest vs vigorous step-up interventions.ResultsAmong 400 participants (mean [SD] age, 40.5 [11.2] years; 305 [76.3%] women; 81 participants were Black and 266 were White; mean [SD] body mass index, 34.4 [4.3]) randomized to undergo WFS (n = 199) vs WFS plus coaching (n = 201), outcome data were available for 342 participants (85.5%) at 6 months. Six-month weight loss was -2.8 kg (95% CI, -3.5 to -2.0) for the WFS group and -4.8 kg (95% CI, -5.5 to -4.1) for participants in the WFS plus coaching group (difference in weight change, -2.0 kg [90% CI, -2.9 to -1.1]; P < .001); the 90% CI included the noninferiority margin of -2.5 kg. Weight change differences were comparable at 3 and 12 months and, among nonresponders, at 6 months, with no difference by step-up therapy.Conclusions and relevanceA wireless feedback system (Wi-Fi activity tracker and scale with smartphone app to provide daily feedback) was not noninferior to the same system with added coaching. Continued efforts are needed to identify strategies for weight loss management and to accurately select interventions for different individuals to achieve weight loss goals.Trial registrationClinicalTrials.gov Identifier: NCT02997943.
| S-EPMC11094642 | biostudies-literature
Project description:Financial incentives could be used to improve adherence to behavioral weight loss interventions, increasing their effectiveness. This Phase IIb randomized pilot study evaluated the feasibility and acceptability of a study protocol for providing financial incentives for dietary self-monitoring and/or weight loss. Community-dwelling adults with obesity were enrolled in a 24 week, group-based weight loss program. Participants were randomized in a 2 × 2 factorial design to receive financial incentives for both dietary self-monitoring and weekly weight loss, just one, or neither. Participants could earn up to $300, evolving from fixed weekly payments to intermittent, variable payments. The notice of reward was provided by text message. The study was conducted in three successive cohorts to evaluate study procedure changes, including dietary approach, recruitment and retention strategies, text messaging, and incentives. Descriptive statistics calculated separately for each cohort described study performance relative to predefined targets for recruitment, including minority representation; retention; adherence; and weight loss. Acceptability was assessed via postintervention qualitative interviews. In Cohort 1 (n = 34), a low-carbohydrate diet was used. Recruitment, retention, adherence, and weight loss were adequate, but minority representation was not. For Cohort 2 (n = 31), employing an additional recruitment method and switching to a reduced-calorie diet yielded adequate recruitment, minority representation, retention, and adherence but less weight loss. Returning to a low-carbohydrate diet in Cohort 3 (n = 28) yielded recruitment, minority representation, retention, adherence, and weight loss similar to Cohort 2. Participant feedback informed changes to text message timing and content and incentive amount. Through successive cohorts, we optimized recruitment and retention strategies and text messaging. An adequately powered trial is warranted to evaluate the efficacy of these incentive structures for reducing weight. The trial registration number is NCT02691260.
| S-EPMC8489416 | biostudies-literature
Project description:BackgroundHealthier lifestyles in early pregnancy are associated with lower rates of pregnancy complications, childhood adiposity, and maternal and child cardiovascular risks. However, it is not known whether lifestyle coaching initiated prior to pregnancy can affect behavior and attitudes during pregnancy.MethodsThree hundred and twenty six women planning pregnancy within 2 years with BMI ≥27 kg/m2 were randomized to a behavioral weight loss intervention or to usual care. Analyses reported here examined the intervention's impact on mid-pregnancy diet quality and activity levels; program acceptability; and effects of pregnancy on intervention engagement.ResultsOne hundred and sixty eight participants experienced pregnancy during the study (intervention: 91; usual care: 77). From randomization to mid-pregnancy, participants who received the intervention had larger increases in fruit intake than usual care participants (+0.67 vs. +0.06 cups; p = 0.02) and engaged in more vigorous-intensity activity (3.9 [5.5] vs. 1.2 [3.0] Met-hr/week p = 0.002) and sports/exercise (17.0 [14.1] vs. 11.0 [9.5] Met-hr/week; p = 0.03); the groups also differed in changes in sedentary time (-4.9 [15.0] vs. +0.5 [7.6] Met-hr/week; p = 0.02). Intervention satisfaction was high (>80%), and experiencing pregnancy during the intervention was associated with higher engagement.ConclusionA coaching-based intervention beginning in pre-pregnancy successfully helped women attain healthier diet and exercise habits in mid-pregnancy.Clinical trials registrationRegistered with ClinicalTrials.gov, NCT02346162, first registered on January 26, 2015, before date of initial participant enrollment (May 2015), https://clinicaltrials.gov/ct2/show/NCT02346162.
| S-EPMC9535669 | biostudies-literature
Project description:ObjectiveThis study tested whether a mindfulness-based intervention for obesity that included components aimed at emotion regulation and mindful eating improved psychological outcomes including stress, anxiety, positive emotion, and depression, during the intervention period and at longer-term follow-up.MethodsAdults with obesity (N=194) were randomized to a 5.5-month diet-exercise weight loss intervention with or without mindfulness training focused on emotion regulation and mindful eating. Participants completed self-report measures of mindfulness and psychological well-being, which were planned secondary outcomes, at baseline, mid-intervention (3 months), and at 6-, 12-, and 18-months post-baseline (maintenance period). Mixed effects models and linear regression were used to test between- and within-group changes in psychological well-being. Finally, this study explored whether changes in mindfulness (from baseline to each 6- and 18-months post-baseline) mediated the effects of intervention arm on changes in psychological outcomes during those respective time periods. This study explored whether changes in mindfulness from baseline to 6 months mediated the effects of intervention arm on changes in psychological outcomes from baseline to 18 months.ResultsParticipants randomized to the mindfulness arm had significant increases in positive emotions at all follow-up times compared to controls. There were statistically significant increases in mindfulness, psychological flexibility, and reflection, as well as decreases in anxiety and depressive symptoms at 12 months compared to control participants. These changes remained significant for psychological flexibility and reflection at 18 months. There were no significant differences in perceived stress. Among mindfulness participants, greater increases in mindfulness from 6-18 months was associated with greater positive emotions and psychological flexibility as well as lower perceived stress, anxiety, depressive symptoms, and rumination at 18 months, adjusting for 6-month values. Mediation analyses indicated that randomization to the mindfulness intervention arm was associated with 6-month increases in mindfulness, and these increases were in turn associated with improved psychological outcomes at 6 months and 18 months. Changes from baseline to 18 months did not mediate 18-month changes in psychological outcomes.ConclusionsMindfulness training in emotion regulation and mindful eating may provide greater longer-term psychological well-being benefits in non-clinical populations with obesity compared to conventional diet-exercise interventions.
| S-EPMC9681158 | biostudies-literature
Project description:ObjectiveLifestyle interventions remain the cornerstone for obesity treatment. Commercial programs offer one weight loss approach, yet the efficacy of few such programs have been rigorously investigated. The purpose of this study was to evaluate the efficacy of two commercial weight-loss programs, both utilizing pre-portioned meal replacements (MRs) and different levels of behavioural support, compared to a self-directed control diet in adults with overweight and obesity.MethodsIn this 16-week study, participants were randomized to the low-calorie OPTAVIA® 5&1 Plan® with telephone coaching (OPT), the reduced-calorie Medifast® 4&2&1 self-guided plan (MED), or a self-directed, reduced-calorie control diet. Differences in weight, body composition (DXA) and body circumferences, all measured monthly, were assessed by analysis of covariance with sex and baseline measures as covariates.ResultsOf 198 participants randomized (80.8% female, BMI 34.2 kg/m2, 45.7 years), 92.3% completed the study. The OPT and MED groups had significantly greater reductions in body weight (-5.7% and - 5.0%, respectively, p < 0.0001), fat and abdominal fat mass (p < 0.0001) and waist and hip circumferences (p ≤ 0.003) than control at 16 weeks. Weight change was correlated with MR usage and completion of coaching support calls.ConclusionsBoth structured commercial programs were more efficacious than a self-directed, reduced-calorie diet for weight loss and other anthropometric measures. Evidence-based commercial programs can be an important tool to help adults with overweight and obesity lose clinically relevant amounts of weight.
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Project description:To evaluate the effects of water versus beverages sweetened with non-nutritive sweeteners (NNS) on body weight in subjects enrolled in a year-long behavioral weight loss treatment program.The study used a randomized equivalence design with NNS or water beverages as the main factor in a trial among 303 weight-stable people with overweight and obesity. All participants participated in a weight loss program plus assignment to consume 24 ounces (710 ml) of water or NNS beverages daily for 1 year.NNS and water treatments were non-equivalent, with NNS treatment showing greater weight loss at the end of 1 year. At 1 year subjects receiving water had maintained a 2.45 ± 5.59 kg weight loss while those receiving NNS beverages maintained a loss of 6.21 ± 7.65 kg (P < 0.001 for difference).Water and NNS beverages were not equivalent for weight loss and maintenance during a 1-year behavioral treatment program. NNS beverages were superior for weight loss and weight maintenance in a population consisting of regular users of NNS beverages who either maintained or discontinued consumption of these beverages and consumed water during a structured weight loss program. These results suggest that NNS beverages can be an effective tool for weight loss and maintenance within the context of a weight management program.
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