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

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.

Symptoms of Depression, Eating Disorders, and Binge Eating in Adolescents With Obesity: The Fast Track to Health Randomized Clinical Trial.

Importance: Depression and eating disorders are heightened for adolescents with obesity. Clinical reviews alongside self-report questionnaires are important to ensure appropriate intervention. Objective: To 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 Participants: This 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. Interventions: Duration 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 Measures: Self-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. Results: Of 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 Relevance: Results 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 Registration: Australian New Zealand Clinical Trials Registry: ACTRN12617001630303.

Eating disorders in weight-related therapy (EDIT): Protocol for a systematic review with individual participant data meta-analysis of eating disorder risk in behavioural weight management.

The Eating Disorders In weight-related Therapy (EDIT) Collaboration brings together data from randomised controlled trials of behavioural weight management interventions to identify individual participant risk factors and intervention strategies that contribute to eating disorder risk. We present a protocol for a systematic review and individual participant data (IPD) meta-analysis which aims to identify participants at risk of developing eating disorders, or related symptoms, during or after weight management interventions conducted in adolescents or adults with overweight or obesity. We systematically searched four databases up to March 2022 and clinical trials registries to May 2022 to identify randomised controlled trials of weight management interventions conducted in adolescents or adults with overweight or obesity that measured eating disorder risk at pre- and post-intervention or follow-up. Authors from eligible trials have been invited to share their deidentified IPD. Two IPD meta-analyses will be conducted. The first IPD meta-analysis aims to examine participant level factors associated with a change in eating disorder scores during and following a weight management intervention. To do this we will examine baseline variables that predict change in eating disorder risk within intervention arms. The second IPD meta-analysis aims to assess whether there are participant level factors that predict whether participation in an intervention is more or less likely than no intervention to lead to a change in eating disorder risk. To do this, we will examine if there are differences in predictors of eating disorder risk between intervention and no-treatment control arms. The primary outcome will be a standardised mean difference in global eating disorder score from baseline to immediately post-intervention and at 6- and 12- months follow-up. Identifying participant level risk factors predicting eating disorder risk will inform screening and monitoring protocols to allow early identification and intervention for those at risk.

Eating Disorders In weight-related Therapy (EDIT) Collaboration: rationale and study design.

The cornerstone of obesity treatment is behavioural weight management, resulting in significant improvements in cardio-metabolic and psychosocial health. However, there is ongoing concern that dietary interventions used for weight management may precipitate the development of eating disorders. Systematic reviews demonstrate that, while for most participants medically supervised obesity treatment improves risk scores related to eating disorders, a subset of people who undergo obesity treatment may have poor outcomes for eating disorders. This review summarises the background and rationale for the formation of the Eating Disorders In weight-related Therapy (EDIT) Collaboration. The EDIT Collaboration will explore the complex risk factor interactions that precede changes to eating disorder risk following weight management. In this review, we also outline the programme of work and design of studies for the EDIT Collaboration, including expected knowledge gains. The EDIT studies explore risk factors and the interactions between them using individual-level data from international weight management trials. Combining all available data on eating disorder risk from weight management trials will allow sufficient sample size to interrogate our hypothesis: that individuals undertaking weight management interventions will vary in their eating disorder risk profile, on the basis of personal characteristics and intervention strategies available to them. The collaboration includes the integration of health consumers in project development and translation. An important knowledge gain from this project is a comprehensive understanding of the impact of weight management interventions on eating disorder risk.

Low-carbohydrate interventions for adolescent obesity: Nutritional adequacy and guidance for clinical practice.

Low-carbohydrate dietary patterns are re-emerging as a popular method of weight reduction. However, their nutritional adequacy to meet the needs of growing adolescents should be considered. This study aimed to design theoretical low-carbohydrate meal plans for clinical use in the management of adolescent obesity and assess nutritional adequacy. Meal plans were created for three levels of carbohydrate restriction (≤30, ≤50 and ≤120 g/day) without energy, protein or total fat restriction. Nutrient analysis was conducted using the FoodWorks Australia Ltd software (databases: AUSNUT 2013, AusBrands 2017, AusFoods 2017, NUTTAB 2010, New Zealand FOODfiles 2016), and compared with Australian Nutrient Reference Values for male and female adolescents aged 14 to 18 years. All low-carbohydrate meal plans met the Recommended Dietary Intake, Adequate Intake or Estimated Average Requirements for most micronutrients at an energy intake of 6.3 to 7.2 MJ/day (1510-1730 kcal/day). The proportion of energy from saturated fat exceeded recommendations across all models (11.3%-17.1%). Dietary manipulation was required to minimize saturated fat and reach micronutrient adequacy, particularly for calcium in males and females, and iron for females. In practice, this may be challenging considering individual lifestyle and preferences. Therefore, the use of low-carbohydrate diets with adolescents should be monitored by a trained professional to ensure nutritional adequacy.

Text Message Behavioral Intervention for Teens on Eating, Physical Activity and Social Wellbeing (TEXTBITES): Protocol for a Randomized Controlled Trial.

BACKGROUND: Obesity is among the most significant health challenges facing today's adolescents. Weight gain during adolescence is related to cardiovascular disease, type 2 diabetes, and some cancers in later life. Presently, adolescents living in Australia have limited access to age-appropriate obesity prevention services. OBJECTIVE: This study aims to investigate whether a two-way text message program, with optional telephone health counseling, improves body mass index (BMI) z score and lifestyle outcomes in adolescents who are overweight. METHODS: This study will be a single-blind randomized controlled trial (N=150) comparing a two-way text message intervention, with optional telephone health counseling, to usual care in adolescents (13-18 years old, inclusive) who are overweight (recruited from a pediatric weight management clinic and the broader community in Sydney, Australia). The intervention group will receive a six-month text message program, which consists of two-way, semipersonalized, lifestyle-focused text messages (four messages/week) in addition to usual care. The control group will be assigned to receive usual care. The study also includes a follow-up at 12-months. The primary outcome is a change in BMI z score at six months. Secondary outcomes are changes in waist-to-height ratio, diet, physical and sedentary activity levels, sleep quality, quality of life, self-esteem, self-efficacy, social support, and eating disorder and depression symptoms. Also, we will examine acceptability, utility, and engagement with the program through a study-specific process evaluation questionnaire, semi-structured telephone interviews, and an analysis of health counselor communication logs. The analyses will be performed by the intention-to-treat principle to assess differences between intervention and control groups. RESULTS: The study opened for recruitment in December 2019. Data collection is expected to be completed by December 2021, and the results for the primary outcome are expected to be published in early 2022. CONCLUSIONS: This study will test the effectiveness of an interactive two-way text message program compared to usual care in improving BMI z score and lifestyle outcomes in adolescents with overweight. This interactive, innovative, and scalable project also aims to inform future practice and community initiatives to promote obesity prevention behaviors for adolescents. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619000389101; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377158&isReview=true. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16481.

Fast track to health - Intermittent energy restriction in adolescents with obesity. A randomised controlled trial study protocol.

BACKGROUND: Intermittent energy restriction (IER) has shown early success in adolescents with obesity, however efficacy trials are needed. This study aims to determine if IER results in lower body mass index (BMI) z-score after 52 weeks in metabolically unhealthy adolescents with obesity compared with continuous energy restriction (CER). METHODS/DESIGN: This is a prospective, randomised, multi-centre trial conducted in tertiary care settings, with three phases: jumpstart (weeks 0-4); intensive intervention (weeks 5-16); continued intervention and/or maintenance (weeks 17-52). During the jumpstart phase, all participants follow a very low energy diet (∼800kcal/3350kJ/day), then transition to their allocated intervention: IER or CER. IER involves three energy-restricted days/week, consuming one-third of daily energy requirements (∼600-700kcal/2500-2950kJ/day), and four days/week of a healthy meal plan. The CER, which is current standard care, has individually tailored energy prescription based on age and sex (13-14years, 1430-1670kcal/6000-7000kJ/day; 15-17years, 1670-1900kcal/7000-8000kJ/day). The study will recruit 186 (93 per arm) treatment-seeking adolescents aged 13-17years with obesity and at least one metabolic co-morbidity. The primary outcome is change in BMI z-score at 52 weeks. Secondary outcomes are changes at 4, 16 and 52 weeks in: body composition; diet quality, food choices and food patterns; cardio-metabolic risk factors; physical activity and sedentary behaviour; sleep and psycho-behavioural measures. DISCUSSION: This study challenges existing clinical paradigms that CER is the only method for weight management in metabolically unhealthy adolescents. If successful, IER may offer an alternate medical nutrition therapy approach for those seeking treatment in tertiary settings. CLINICAL TRIAL REGISTRATION NUMBER: ACTRN12617001630303.

'Not to Be Harsh but Try Less to Relate to 'the Teens' and You'll Relate to Them More': Co-Designing Obesity Prevention Text Messages with Adolescents.

Text messages remain a preferred way for adolescents to communicate, and recent evidence suggests adolescents would like access to digital healthcare options. However, there is limited evidence for text messages to engage adolescent populations in obesity prevention behaviors. We aimed to co-design a bank of text messages that are evidence-based, acceptable, and engaging for adolescents. An established iterative mixed methods process, consisting of three phases, was used to develop the text message program. The first bank of 145 text messages was drafted based on current evidence, behavior change techniques, and input from researchers and health professionals. A survey was then administered to adolescents and professionals for review of text message content, usefulness, understanding, and age-appropriateness. An adolescent research assistant collaborated with the research team on all three phases. Forty participants (25 adolescents and 15 professionals) reviewed the initial bank of 145 text messages. On average, all reviewers agreed the text messages were easy to understand (13.6/15) and useful (13.1/15). In total, 107 text messages were included in the final text message bank to support behavior change and prevent obesity. This study may guide other researchers or health professionals who are seeking to engage adolescents in the co-design of health promotion or intervention content. Effectiveness of the text message program will be tested in a randomized controlled trial.