Dataset Information

Intermittent Energy Restriction for Adolescents With Obesity: The Fast Track to Health Randomized Clinical Trial.

ABSTRACT:

Importance

Adolescent obesity requires effective and accessible treatment. Intensive dietary interventions have the potential to be used as adjunctive therapy for behavioral weight management.

Objective

To examine the effectiveness of 2 diet therapies, delivered as part of an intensive behavioral weight management intervention, in adolescents with metabolic complications associated with obesity.

Design, setting, and participants

This multisite, 52-week randomized clinical trial was conducted from January 31, 2018, to March 31, 2023, at 2 tertiary pediatric centers in Australia. Adolescents (aged 13-17 years) with obesity and 1 or more associated complications were included.

Interventions

Intensive behavioral interventions, delivered by a multidisciplinary team, comparing intermittent energy restriction (IER) or continuous energy restriction (CER), with 3 phases: very low-energy diet (weeks 0-4), intensive intervention (weeks 5-16), and continued intervention and/or maintenance (weeks 17-52).

Main outcomes and measures

The primary outcome was body mass index (BMI) z score at 52 weeks in the IER vs CER group. Anthropometry, body composition, and cardiometabolic health were assessed at baseline and 52 weeks. The BMI z score and percentiles were determined using Centers for Disease Control and Prevention growth charts. Insulin resistance, dyslipidemia, and elevated hepatic function were assessed.

Results

A total of 141 adolescents (median [IQR] age, 14.8 [12.9-17.9] years; 71 male [50.4%]) were enrolled, 71 in the IER group and 70 in the CER group, and 97 (68.8%) completed the intervention, 43 in the IER group and 54 in the CER group. At week 52, both groups had reduced BMI z scores (estimated marginal mean change, -0.28 [95% CI, -0.37 to -0.20] for IER and -0.28 [95% CI, -0.36 to -0.20] for CER) and reduced BMI expressed as a percentage of the 95th percentile (estimated marginal mean change, -9.56 [95% CI, -12.36 to -6.83] for IER and -9.23 [95% CI, -11.82 to -6.64] for CER). No differences were found in body composition or cardiometabolic outcomes between the groups. Both groups had a reduction in the occurrence of insulin resistance (from 52 of 68 [76.5%] to 32 of 56 [57.1%] in the IER group and from 59 of 68 [86.8%] to 31 of 60 [57.1%] in the CER group) at week 16; however, at week 52, this effect was observed in the CER group only (from 59 of 68 [86.7%] to 30 of 49 [61.2%]). The occurrence of dyslipidemia was unchanged between baseline and week 52 (60 of 137 [42.6%] and 37 of 87 [42.5%], respectively), with a small improvement in occurrence of impaired hepatic function tests (37 of 139 [27.0%] and 15 of 87 [17.2%], respectively). No differences were found in dyslipidemia or hepatic function between groups.

Conclusions and relevance

These findings suggest that for adolescents with obesity-associated complications, IER can be incorporated into a behavioral weight management program, providing an option in addition to CER and offering participants more choice.

Trial registration

http://anzctr.org.au Identifier: ACTRN12617001630303.

SUBMITTER: Lister NB

PROVIDER: S-EPMC11348084 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Intermittent Energy Restriction for Adolescents With Obesity: The Fast Track to Health Randomized Clinical Trial.

Lister Natalie B NB Baur Louise A LA House Eve T ET Alexander Shirley S Brown Justin J Collins Clare E CE Cowell Christopher T CT Day Kaitlin K Garnett Sarah P SP Gow Megan L ML Grunseit Alicia M AM Henderson Maddison M Inkster Mary-Kate MK Kwok Cathy C Lang Sarah S Paxton Susan J SJ Truby Helen H Varady Krista A KA Jebeile Hiba H

JAMA pediatrics 20241001 10

<h4>Importance</h4>Adolescent obesity requires effective and accessible treatment. Intensive dietary interventions have the potential to be used as adjunctive therapy for behavioral weight management.<h4>Objective</h4>To examine the effectiveness of 2 diet therapies, delivered as part of an intensive behavioral weight management intervention, in adolescents with metabolic complications associated with obesity.<h4>Design, setting, and participants</h4>This multisite, 52-week randomized clinical t ...[more]

PMID: 39186288

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Project description:ImportanceDepression and eating disorders are heightened for adolescents with obesity. Clinical reviews alongside self-report questionnaires are important to ensure appropriate intervention.ObjectiveTo evaluate changes in self-report symptoms of depression, eating disorders, and binge eating in adolescents with obesity during the Fast Track to Health trial.Design, setting, and participantsThis was a randomized clinical trial conducted from 2018 to 2023. It was a multisite trial conducted at children's hospitals in Sydney, New South Wales, and Melbourne, Victoria, Australia, and included adolescents (13-17 years) with obesity (defined as adult equivalent body mass index ≥30; calculated as weight in kilograms divided by height in meters squared) and 1 or more related complications.InterventionsDuration was 52 weeks including a very low energy diet for 4 weeks followed by intermittent energy restriction (IER) or continuous energy restriction (CER).Main outcomes and measuresSelf-report symptoms of depression (Center for Epidemiologic Studies Depression Scale-Revised 10-Item Version for Adolescents [CESDR-10]; scores 0-30), eating disorders (Eating Disorder Examination Questionnaire [EDE-Q]; scores 0-6), and binge eating (Binge Eating Scale [BES]; scores 0-46) were assessed. Adolescents were screened for depression and eating disorders (weeks 0, 4, 16, and 52) and monitored for the onset of new symptoms of disordered eating during dietetic consults.ResultsOf 141 adolescents (median [IQR] age, 14.8 [12.9-17.9] years; 71 male [50.4%]) enrolled, median baseline EDE-Q score was 2.28 (IQR, 1.43-3.14), median baseline CESDR-10 score was 9.00 (IQR, 4.00-14.50), and median baseline BES score was 11.00 (IQR, 5.00-17.00). There were no differences between groups for change in CESDR-10 (mean difference at week 52, 0.75; 95% CI, -1.86 to 3.37), EDE-Q (mean difference at week 52, 0.02; 95% CI, -0.41 to 0.45), or BES (mean difference at week 52, -2.91; 95% CI, -5.87 to 0.05). The within-group reductions at week 4 were maintained at week 52, for CESDR-10 and EDE-Q, indicating reduced symptoms of depression and eating disorders. Within-group reductions on the BES were maintained in the IER group only. Seventeen adolescents (12.1%) required support or referral for depression and/or disordered eating, including 7 (5%; 5 IER, 2 CER) adolescents who experienced the onset or reemergence of symptoms during the intervention.Conclusions and relevanceResults suggest that many treatment-seeking adolescents with obesity self-reported symptoms of depression and eating disorders. Although symptoms reduced for most, some required additional support. Obesity treatment is an opportune time to screen and monitor for depression and disordered eating.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12617001630303.

Project description:BACKGROUND:The Food Guide for the Brazilian Population relies on natural or minimally processed foods mainly of plant origin such as beans and rice with low oil, salt, and sugar content and limited consumption of ultraprocessed foods. Reduction of ultraprocessed foods improves diet quality and energy consumption. OBJECTIVE:The goal of this study is to evaluate the effectiveness of an intervention for the treatment of obesity in children, with counseling based on the Brazilian Food Guide plus control of total energy intake. METHODS:A parallel, randomized clinical trial will include children aged 7 to 12 years. Randomization will be performed in blocks of 10 individuals using computer-generated random sequence numbers. Both the control and intervention groups will participate in 6 standardized educational activities based on the 10 steps of the Brazilian Food Guide. These activities will be conducted at the University Hospital Toy Library, located in the pediatric outpatient clinic. For the intervention group, in addition to the educational activities, an individualized food plan based on the nutritional recommendations of the Brazilian Society of Pediatrics will be prescribed and discussed with the mothers and fathers. The primary outcome of the study will be variations in body mass index, and secondary outcomes will include analysis of insulin resistance, blood pressure, body fat percentage, and waist and neck circumference. RESULTS:This project was funded by the National Council for Scientific and Technological Development in December 2017 (grant no 408333/2017-0). Recruitment began in August 2018 and by September 2019, we had enrolled the 101 participants. In addition to the patients referred by the national system of regulation, recruitment was made by medical outpatient referral and external indication. This is an ongoing study. We expect the results to be published in November 2020. CONCLUSIONS:At the end of the project, in case of a positive result, a protocol for the treatment of obesity based on the Brazilian Food Guide will be proposed to the Unified Health System. A successful method to reduce childhood obesity is expected. TRIAL REGISTRATION:Brazilian Registry of Clinical Trials RBR-3st5sn; http://www.ensaiosclinicos.gov.br/rg/RBR-3st5sn. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/16170.

Dataset Information

Intermittent Energy Restriction for Adolescents With Obesity: The Fast Track to Health Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Intermittent Energy Restriction for Adolescents With Obesity: The Fast Track to Health Randomized Clinical Trial.

Similar Datasets

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