eBATTLE Obesity

Background

In Norway, up to 23% of adolescents have overweight or obesity. Adolescent obesity is not only a psychosocial burden, but it is also associated with increased mortality in adulthood from cardiovascular disease and shortened life expectancy.

An overview of six Cochrane systematic reviews on the effectiveness of behavioral interventions, surgery and drugs in adolescents or children with obesity and their parents, provided evidence that multi-component behavior changing interventions might be beneficial in achieving a small reduction in body weight, with a low occurrence of adverse events. Evidence from surgical and pharmaceutical interventions was too limited to make inferences about their effectiveness or safety, but adverse events were a serious concern.

Digital health interventions (eHealth)

Electronic health (eHealth) can be defined as the use of technology to support, health, well-being and healthcare. Digital health interventions may be delivered through various types of information and communication technologies to support health behavior change. Adolescents play the role as digital frontrunners, and eHealth may be particularly useful to improve current adolescent obesity treatment strategies. However, little is known about the feasibility and effectiveness of eHealth interventions in adolescent obesity, and further study is needed.

Cognitive behavioral therapy (CBT)

Behavioral therapy is recommended as the best documented and effective framework for various psychological techniques implementing new healthy dietary and physical activity habits. Many programs also include cognitive components (e.g. CBT) addressing maintaining factors for unhealthy habits, producing additional positive effects on co-morbid depressive symptoms, body image and self-esteem issues. CBT may be used as a framework both during the weight reduction and weight maintenance phase. Traditional CBT for obesity specifically outlines the importance of using it in a weight stabilization phase of treatment, aiming to establish everyday habits that are sustainable over time and address how to handle stress and setbacks that may threaten long term healthy weight management.

Behavior change is complex, and behavior change interventions usually contain multiple active components or techniques targeting both behavioral, cognitive and emotional aspects Unpublished results from an RCT in Bergen (the FABO study) show that a family-based CBT provided a clinical meaningful weight loss in significantly more children and adolescents than treatment as usual, with 6.6% versus 1.9% decrease in %IOTF-25. Accordingly, an eHealth supported behavioral intervention might facilitate the behavior change required to maintain long-term weight stabilisation.

Low-energy-diet (LED) and very-low-energy-diet (VLED)

The efficacy and safety of VLED (<800 kcal/day) programs for weight loss in children and adolescents with obesity were assessed in a systematic review with meta-analysis (17). Weight-related outcomes improved in all studies with a mean weight loss of 10 kg following interventions lasting 3-20 weeks.. VLED and LED may be administered as meal replacement or food based diets. Potential side effects include dehydration, constipation, fatigue, headaches, dizziness, bad breath (halitosis), hypoglycemia, gallstones, and gastrointestinal side effects, and rarely, hypocalcemia, urolithiasis and hair loss. Our own experience indicates that an LED (800-1200 kcal/day) induces similarly large weight losses in patients with severe obesity, possibly with fewer side-effects, which might be particularly important in adolescents (Martins C et al).

Medications for weight loss and weight maintenance

Lifestyle intervention does not adequately reduce excess adiposity in youth suffering from severe obesity and antiobesity pharmacotherapy is underutilized. An RCT of adolescents (12 to <18 years) with obesity showed that liraglutide was superior to placebo with a 5% greater reduction in BMI. Few participants had serious adverse events (3 [2.4%] vs. 5 [4.0%]) (22). In 2021, an RCT of adults with obesity showed that 68 weeks’ treatment with once-weekly sc. semaglutide vs placebo, combined with intensive behavioral therapy and an LED for the initial 8 weeks, resulted in weight losses of 16% vs 6%, respectively (23). STEP TEEN is an ongoing RCT comparing the 68-week effect of semaglutide 2.4 mg once weekly and placebo on BMI-change in adolescents with overweight or obesity. Estimated study completion date is March 30, 2022 (A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity - Full Text View - ClinicalTrials.gov).

In summary, current non-surgical lifestyle treatment of severe adolescent obesity is associated with an average small to moderate short-term weight loss. Accordingly, there is an urgent need for studies evaluating the efficacy and safety of potentially more effective intervention strategies including low-energy-diets and anti-obesity drugs.

Objectives

 The primary objectives of the eBATTLE Obesity trial are:

1. to evaluate the feasibility, safety, and effectiveness of an 8-week low energy diet (LED) in adolescents (12-18 years) with severe obesity (weeks 0-8).
2. to evaluate the feasibility of a 52-week eHealth-Cognitive Behavioral Therapy (eCBT) for weight loss maintenance (weeks 9-60).
3. to compare weight loss maintenance and adverse effects of 52-week eCBT with once-weekly semaglutide versus with placebo in an RCT (week 9-60).
4. To study fatty liver biomarkers (lipidomics, microbiome)
5. To assess the frequency of Serious Adverse Events

Period

2022-2026

Contact

Rønnaug Ødegård

Funding

Total budget 20 000 000 NOK

Funding body: The Norwegian Health Authority

Collaboration

• Principal investigator (PI): Vestfold Health Trust (Tønsberg).
• Co-PI: CORI, St Olav University Hospital and Haukeland University hospital (Bergen)
• Oslo University Hospital, UNN Tromsø and Nordland Hospital Bodø

For Norwegian

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