FutureShape Family: a family-based weight-management program with semaglutide for children and parents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 4, interventional study enrolling families where at least one parent has obesity and one child is overweight or obese. The study compares a pharmacologic treatment (semaglutide) plus standard care and app-based family support against placebo with standard care and app-based family support. The approach targets multiple modifiable behaviors, including physical activity, diet, and sleep, in a data-driven, personalized manner. Participants include adult index parents, their children aged 5–12, and other household members; eligibility requires residency in Denmark and Danish language ability. Primary care and pediatric settings in Denmark will collaborate to deliver the intervention.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Family living in the same household with at least one Index Parent and one Index Child living with overweight/obesity (see below).
* Written informed consent from all adult participants (age ≥18 years), participants between the ages of 15-17 years, and from the parental authority of the children (age \<18 years).
* Permanent residency in Denmark and able to speak Danish at a level to understand trial requirements.

Index Parent(s):

* Living with obesity (BMI ≥30 kg/m2).
* Biological, adoptive parent, or legal guardian of the Index child.
* Resides with the Index child at least 50% of the time.
* Index parent(s) must be in possession of a smartphone and able to use an app-based solution
* A maximum of two Index Parents per family can participate in the trial.

Index Child(ren):

• Aged 5 to 12 years with overweight or obesity (BMI \> +1 BMI z-score (\>85th percentile) for age and sex assigned at birth).

Other members of the household:

• All other members (non-Index parent(s) and non-Index child(ren)) of the household are invited to be included in the study and participate partly by wearing an accelerometer, wrist-worn activity tracker (e.g., a smartwatch), physical activity testing, answering questionnaires, and measurements of weight and body composition.

Exclusion Criteria:

* Known serious chronic conditions, including type 1 or 2 diabetes
* Known medical conditions that hinder physical activity to a significant degree.
* Treatment for cancer at screening other than oestrogen antagonist therapy or non-melanoma skin cancer.
* Known severe psychiatric disease, a history of major depressive episodes, or other serious psychiatric disorders.
* Known diagnosis or treatment for an eating disorder within the last 6 months
* Known medical conditions or use of medication significantly affecting growth (Index Child) or causing clinically significant weight gain or weight loss (Index Parent(s) or Index Child) within the last 6 months before screening.
* Bariatric surgery and weight-related surgeries (e.g., gastric bypass) within the last two years.

Relating to semaglutide (Index Parent(s)) (according to the SmPC: https://www.ema.europa.eu/en/documents/product-information/wegovy-epar-product-information\_en.pdf)

* Hypersensitivity to the active substance (semaglutide) or to any of the excipients used (Disodium phosphate, dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide, propylene glycol, phenol).
* Known severe renal impairment (eGFR \<30 mL/min/1.73m2), including participants with end-stage renal disease.
* Known severe hepatic impairment.
* Known severe stomach or gut problem, which results in delayed stomach emptying (called gastroparesis), or if you have an inflammatory bowel disease.
* Known congestive heart failure, New York Heart Association (NYHA) class IV.
* Known diabetic eye disease (retinopathy).
* Known current or previous pancreatitis.
* Pregnancy, expecting pregnancy (during the study), or breastfeeding. If a study participant is in doubt whether they could be pregnant, a urine pregnancy test is performed. Adequate contraception must be used throughout the study period and at least 2 months after discontinuation of semaglutide (semaglutide is present in the circulation for 7 weeks after the last dose).
* A family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma

Where it's running

• University of Copenhagen, Department of Biomedical Sciences
  Copenhagen, Denmark Recruiting

Study contacts

• Principal investigator: Signe Torekov, Professor — University of Copenhagen
• Study coordinator: Study Team
• Email: FutureShape@sund.ku.dk
• Phone: +4593565828

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.