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FutureShape Family
Sponsor: Signe Torekov
Summary
The number of adults and children living with obesity is increasing worldwide. Once childhood obesity has developed, more than 80% of children carry the obesity into adulthood, with a high risk of cardiometabolic disease, poor mental health, and decreased life expectancy. Parental obesity is a strong predictor of intergenerational obesity and is closely associated with a child's body composition from childhood through to adulthood. Obesity pharmacotherapy effectively reduces body weight. In adults, we have shown that combining obesity pharmacotherapy with supervised exercise improves weight-loss maintenance compared with pharmacotherapy alone. Emerging evidence suggest that exercise may also limit weight regain after treatment cessation. Together with evidence linking physical activity, sleep, and eating behaviours to weight regulation, these findings support combining pharmacological treatment with interventions targeting multiple modifiable behaviours. Personalised, data-driven feedback may further facilitate sustained behavioural change, but few interventions have integrated these approaches within the family setting. This 58-week randomized clinical trial aims to investigate the separate and combined effects of a data-driven, multimodal family-based intervention and semaglutide treatment for parents with obesity on body fat percentage and other health-related outcomes in parents and children. Approximately 400 families will be randomly assigned to one of four groups combining data-driven, multimodal family-based intervention or standard health advice with semaglutide or placebo. The data-driven, multimodal family-based intervention focuses on physical activity, diet, sleep and mental well-being. The trial will include families with at least one parent with obesity and at least one child aged 5 to 12 years with overweight or obesity. Participating parents with obesity will receive semaglutide or placebo once weekly for 28 weeks. The main outcomes are changes in body fat percentage in participating parents and children. Other outcomes include changes in body mass index (BMI) in parents and age- and sex-adjusted BMI, known as BMI z-score, in children. Families will participate in the main trial for 58 weeks and complete an additional follow-up assessment at week 104 after randomization.
Official title: FutureShape Family: A Randomised Controlled Trial of an Enhanced Family Care Intervention Targeting Intergenerational Obesity
Key Details
Gender
All
Age Range
5 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-10-01
Completion Date
2031-01-31
Last Updated
2026-10-14
Healthy Volunteers
Yes
Conditions
Interventions
Family Care
Family Care will be parent-focused but designed to involve the entire family through parent education, individualized guidance based on study assessment and family preferences, supervised exercise sessions (online and on-site) for the families, and feed-back delivered using an app solution and wearable activity trackers.
Standard Care
Standard Care consist of recommendations on physical activity, sleep, and dietary habits and will be based on the current recommendations from, e.g., WHO, Nordic Nutrition Recommendations, the American Academy of Sleep Medicine, and the Sleep Research Society.
Semaglutide (administered by PDS290 pen-injector)
Semaglutide (3.2 mg/ml) is self-administered subcutaneously via a PDS290 pen-injector. Treatment will have a duration of 28 weeks and consist of a dose escalation phase (up to 2.4 mg/week) and dose reduction phase.
Placebo (administered by PDS290 pen-injector)
Placebo is self-administered subcutaneously via a PDS290 pen-injector. Treatment will have a duration of 28 weeks and consist of a dose escalation phase (up to 2.4 mg/week) and dose reduction phase.
Locations (1)
University of Copenhagen, Department of Biomedical Sciences
Copenhagen, Denmark