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RecruitingPhase 4

FutureShape Family

FutureShape Family: A Randomised Controlled Trial of an Enhanced Family Care Intervention Targeting Intergenerational Obesity

Lead sponsor

Signe Torekov

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Estimated enrollment

400

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥30

Primary endpoint

•Body fat percentage

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07872904
Org study IDU1111-1324-8628
Secondary ID2025-0304Sundhedsdonationer
Secondary IDH-25043094The Scientific Ethics Committees of the Capital Region of Denmark
Secondary IDNNF20SA0067242Danish Cardiovascular Academy (DCA)
Secondary IDNNF22SA0079901Danish Diabetes and Endocrine Academy (DDEA)
Secondary IDNNF24OC0088515Novo Nordisk Foundation

Timeline

Milestones

Study start2026-10-01estimated
Study first posted2026-10-14actual
Last update posted2026-10-29actual
Primary completion2030-05-31estimated
Study completion2031-01-31estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age5 Years
SexAll
Healthy volunteersAccepted

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

Endpoints (69)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
50
Weight & body composition
6
Glycemic / diabetes
5
Cardiometabolic biomarkers
4
Patient-reported / QoL
3
Renal / kidney
1

Weight & body composition

6 endpoints
Secondary/protocol endpoint

Change in body weight

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI-Z score

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Secondary/protocol endpoint

Change in body composition

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Secondary/protocol endpoint

Change in waist-to-height ratio

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint

To explore the changes in family dynamics and support for weight maintenance

Time frame:Change from baseline to end-of-treatment (58 weeks)

descriptive

Glycemic / diabetes

5 endpoints
Other/protocol endpoint

Change in glucose

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint

Change in insulin

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint

Change in C-peptide

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint

Change in HbA1c

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint

Change in indices of insulin sensitivity and resistance

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Renal / kidney

1 endpoint
Other/protocol endpoint

Change in renal-function and electrolyte biomarkers

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints
Other/protocol endpoint

Change in Lipid Markers

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint

Change in systolic and diastolic blood pressure

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint

Change in resting heart rate

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint

Change in circulating inflammatory markers

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Patient-reported / QoL

3 endpoints
Other/protocol endpoint

To explore the feasibility and satisfaction of the Family Care

Time frame:Change from baseline to end-of-treatment (58 weeks)

descriptive

Other/protocol endpoint

Change in health-related quality of life

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint

Change in well-being and quality of life

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other (unclassified)

50 endpoints
Primary/protocol endpoint/low confidence

Change in body fat percentage

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in proinsulin

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in glucagon

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in GLP-1

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in GIP

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in Exploratory Metabolic Biomarkers

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in prevalence of metabolic syndrome

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in metabolic-syndrome z-score

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in Circulating Sex hormones

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in VO₂max

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in peak power output

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in one-repetition maximum leg-extension strength

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in handgrip strength

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in sit-to-stand performance

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in stair-climbing performance

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in 20-metre sprint performance

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in standing long-jump performance

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in physical activity

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in sedentary behaviour

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in cognitive and motivational task profile

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in self-efficacy

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in psychosocial functioning

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in Edmonton Obesity Staging System stage

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in Edmonton Obesity Staging System for Pediatrics stage

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in liver-function biomarkers

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in pancreatic-function biomarkers

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in haematological biomarkers

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in coagulation and fibrinolysis biomarkers

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in thyroid-function biomarkers

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in bone mineral density

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in circulating IGF-1

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in bone-health biomarkers

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in anthropometric measures of growth

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in Tanner stage

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in dietary behaviours

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in eating behaviour

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in feeding practices

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in binge-eating symptoms

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in subjective appetite ratings

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in appetite-related biomarkers

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in sleep duration

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in sleep quality

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

To explore the changes in faecal microbiome

Time frame:Change from baseline to end-of-treatment (58 weeks)

descriptive

Other/protocol endpoint/low confidence

To explore the changes in urine metabolomics

Time frame:Change from baseline to end-of-treatment (58 weeks)

descriptive

Other/protocol endpoint/low confidence

Change in the Metabolomic Profile

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in systemic levels of metabolic disruptors

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in cellular and genetic markers

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in genomics profile

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in transcriptomics profiles

Time frame:Change from baseline to end-of-treatment (58 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Follow-up health

Time frame:Changes from baseline or end of treatment to 46 weeks after the interventions have ended.

descriptive

Publications (9)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.