Dataset Information

Randomized Controlled Lifestyle Intervention (LION) Study for Weight Loss and Maintenance in Adults With Obesity-Design and Methods.

ABSTRACT: Introduction: Due to the increasing prevalence of obesity, approaches for a more effective treatment especially in the long-term perspective are needed. However, studies on weight loss and maintenance show heterogeneous results with large inter-individual variations. Therefore, it is of interest to identify factors that contribute to inter-individual differences and predict the success of long-term weight management. Methods and Analysis: The primary outcome of the Lifestyle Intervention (LION) Study is to evaluate the effect of two diets (low carb vs. low fat) and two digital counseling tools (newsletter vs. mobile application) on weight maintenance 12 months after weight loss. The identification of predictive factors (e.g., genetic, epigenetic, physiological, psychological) for the success of weight loss and maintenance is a secondary outcome. Men and women with a body mass index (BMI) between 30.0 and 39.9 kg/m2, aged 18-65 years, and without severe diseases are considered eligible. After phenotyping (e.g., anthropometry, resting metabolic rate, meal challenges, blood parameters) participants will follow a formula-based, low-calorie diet (LCD) for 8 weeks. In addition, the intake of 200 g raw or cooked non-starchy vegetables are allowed per day. Subsequently, 252 participants will be randomized into one of the four intervention groups (low carb/app, low carb/newsletter, low fat/app, low fat/newsletter) for the 12-month weight maintenance step. The study will be concluded after another 12 months of follow-up. Results should provide indications for successful weight management and give insights into the personalized treatment of obesity. Ethics and Dissemination: This study has been granted ethical approval by the local Ethics Review Committee of the School of Medicine, Technical University of Munich (vote: 69/19 S). Trial Registration Number: This study has been registered within ClinicalTrials.gov (NCT04023942) and the German Clinical Trials Register (DRKS00017819).

SUBMITTER: Reik A

PROVIDER: S-EPMC7683381 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Randomized Controlled Lifestyle Intervention (LION) Study for Weight Loss and Maintenance in Adults With Obesity-Design and Methods.

Reik Anna A Holzapfel Christina C

Frontiers in nutrition 20201110

<b>Introduction:</b> Due to the increasing prevalence of obesity, approaches for a more effective treatment especially in the long-term perspective are needed. However, studies on weight loss and maintenance show heterogeneous results with large inter-individual variations. Therefore, it is of interest to identify factors that contribute to inter-individual differences and predict the success of long-term weight management. <b>Methods and Analysis:</b> The primary outcome of the Lifestyle Interv ...[more]

PMID: 33240920

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Project description:ImportanceGenome-wide association studies have identified genetic loci influencing obesity risk in children. However, the importance of these loci in the associations with weight reduction through lifestyle interventions has not been investigated in large intervention trials.ObjectiveTo evaluate the associations between various obesity susceptibility loci and changes in body weight in children during an in-hospital, lifestyle intervention program.Design, setting, and participantsLong-term Effects of Lifestyle Intervention in Obesity and Genetic Influence in Children (LOGIC), an interventional prospective cohort study, enrolled 1429 children with overweight or obesity to participate in an in-hospital lifestyle intervention program. Genotyping of 56 validated obesity single-nucleotide variants (SNVs) was performed, and the associations between the SNVs and body weight reduction during the intervention were evaluated using linear mixed-effects models for each SNV. The LOGIC study was conducted from January 6, 2006, to October 19, 2013; data analysis was performed from July 15, 2015, to November 6, 2016.ExposuresA 4- to 6-week standardized in-hospital lifestyle intervention program (daily physical activity, calorie-restricted diet, and behavioral therapy).Main outcomes and measuresThe association between 56 obesity-relevant SNVs and changes in body weight and body mass index.ResultsOf 1429 individuals enrolled in the LOGIC Study, 1198 individuals (mean [SD] age, 14.0 [2.2] years; 670 [56%] girls) were genotyped. A mean (SD) decrease was noted in body weight of -8.7 (3.6) kg (95% CI, -15.7 to -1.8 kg), and body mass index (calculated as weight in kilograms divided by height in meters squared) decreased by -3.3 (1.1) (95% CI, -5.4 to -1.1) (both P < .05). Five of 56 obesity SNVs were statistically significantly associated with a reduction of body weight or body mass index (all P < 8.93 × 10-4 corresponding to Bonferroni correction for 56 tests). Compared with homozygous participants without the risk allele, homozygous carriers of the rs7164727 (LOC100287559: 0.42 kg; 95% CI, 0.31-0.53 kg, P = 4.00 × 10-4) and rs12940622 (RPTOR: 0.35 kg; 95% CI, 0.18-0.52 kg; P = 1.86 × 10-5) risk alleles had a lower reduction of body weight, whereas carriers of the rs13201877 (IFNGR1: 0.65 kg; 95% CI, 0.51-0.79 kg; P = 2.39 × 10-5), rs10733682 (LMX1B: 0.45 kg; 95% CI, 0.27-0.63 kg; P = 6.37 × 10-4), and rs2836754 (ETS2: 0.56 kg; 95% CI, 0.38-0.74 kg; P = 1.51 × 10-4) risk alleles were associated with a greater reduction of body weight after adjustment for age and sex.Conclusions and relevanceGenes appear to play a minor role in weight reduction by lifestyle in children with overweight or obesity. The findings suggest that environmental, social, and behavioral factors are more important to consider in obesity treatment strategies.

Project description:BackgroundScalable weight loss maintenance (WLM) interventions for adults with obesity are lacking but vital for the health and economic benefits of weight loss to be fully realised. We examined the effectiveness and cost-effectiveness of a low-intensity technology-mediated behavioural intervention to support WLM in adults with obesity after clinically significant weight loss (≥5%) compared to standard lifestyle advice.Methods and findingsThe NULevel trial was an open-label randomised controlled superiority trial in 288 adults recruited April 2014 to May 2015 with weight loss of ≥5% within the previous 12 months, from a pre-weight loss BMI of ≥30 kg/m2. Participants were self-selected, and the majority self-certified previous weight loss. We used a web-based randomisation system to assign participants to either standard lifestyle advice via newsletter (control arm) or a technology-mediated low-intensity behavioural WLM programme (intervention arm). The intervention comprised a single face-to-face goal-setting meeting, self-monitoring, and remote feedback on weight, diet, and physical activity via links embedded in short message service (SMS). All participants were provided with wirelessly connected weighing scales, but only participants in the intervention arm were instructed to weigh themselves daily and told that they would receive feedback on their weight. After 12 months, we measured the primary outcome, weight (kilograms), as well as frequency of self-weighing, objective physical activity (via accelerometry), psychological variables, and cost-effectiveness. The study was powered to detect a between-group weight difference of ±2.5 kg at follow-up. Overall, 264 participants (92%) completed the trial. Mean weight gain from baseline to 12 months was 1.8 kg (95% CI 0.5-3.1) in the intervention group (n = 131) and 1.8 kg (95% CI 0.6-3.0) in the control group (n = 133). There was no evidence of an effect on weight at 12 months (difference in adjusted mean weight change from baseline: -0.07 [95% CI 1.7 to -1.9], p = 0.9). Intervention participants weighed themselves more frequently than control participants and were more physically active. Intervention participants reported greater satisfaction with weight outcomes, more planning for dietary and physical activity goals and for managing lapses, and greater confidence for healthy eating, weight loss, and WLM. Potential limitations, such as the use of connected weighing study in both trial arms, the absence of a measurement of energy intake, and the recruitment from one region of the United Kingdom, are discussed.ConclusionsThere was no difference in the WLM of participants who received the NULevel intervention compared to participants who received standard lifestyle advice via newsletter. The intervention affected some, but not all, process-related secondary outcomes of the trial.Trial registrationThis trial is registered with the ISRCTN registry (ISRCTN 14657176; registration date 20 March 2014).

Dataset Information

Randomized Controlled Lifestyle Intervention (LION) Study for Weight Loss and Maintenance in Adults With Obesity-Design and Methods.

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Randomized Controlled Lifestyle Intervention (LION) Study for Weight Loss and Maintenance in Adults With Obesity-Design and Methods.

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