ClinicalTrials.gg
Sign In
Not yet recruitingNCT07872904Updated Oct 14, 2026

FutureShape Family

A Phase 4 interventional study of Family Care and Standard Care in Obesity and Overweight, sponsored by Signe Torekov. Not yet recruiting at 1 site in Denmark. Open to participants aged 5 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by Signe Torekov · Phase 4, Interventional, and Treatment

Updated Oct 14, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
5 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
  • Overweight

Keywords

  • Family-based intervention
  • Intergenerational obesity
  • Physical activity
  • Diet
  • Sleep
  • GLP-1 Receptor Agonist
  • Digital health
  • Behavioural intervention
  • obesity
  • overweight
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's planned enrollment of 400 is above the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Signe Torekov is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    Enhanced Family Care

    Family Care, an enhanced, data driven, multimodal intervention. Index parent(s) will receive s.c. semaglutide for 28 weeks (up to 2.4 mg/week).

    Behavioral: Family Care · Drug: Semaglutide (administered by PDS290 pen-injector)

  • Active comparator
    Family Care

    Family Care, an enhanced, data driven, multimodal intervention. Index parent(s) will receive s.c. placebo for 28 weeks (volume matched with semaglutide).

    Behavioral: Family Care · Drug: Placebo (administered by PDS290 pen-injector)

  • Active comparator
    Enhanced Standard Care

    Standard Care, standard recommendation on diet, sleep, and exercise. Index parent(s) will receive s.c. semaglutide for 28 weeks (up to 2.4 mg/week).

    Behavioral: Standard Care · Drug: Semaglutide (administered by PDS290 pen-injector)

  • Placebo comparator
    Standard Care

    Standard Care, standard recommendation on diet, sleep, and exercise. Index parent(s) will receive s.c. placebo for 28 weeks (volume matched with semaglutide).

    Behavioral: Standard Care · Drug: Placebo (administered by PDS290 pen-injector)

Interventions

  • BehavioralFamily 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.

  • BehavioralStandard 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.

  • DrugSemaglutide (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.

  • DrugPlacebo (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.

06

What researchers measure

Primary outcomes

  1. Change in body fat percentage

    In Index Parent(s) and Index Child(ren): Dual-energy X-ray absorptiometry scans will be performed in fasting state to measure body fat percentage (%).

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

Secondary outcomes

  1. Change in body weight

    In Index Parent(s) and Index Child(ren): Weight will be measured to the nearest 0.1 kg and should be measured in a fasting state.

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

  2. Change in BMI

    In Index Parent(s): Weight will be measured to the nearest 0.1 kg and should be measured in a fasting state. Height will be measured to the nearest 0.1 cm.

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

  3. Change in BMI-Z score

    In Index Child(ren): Weight will be measured to the nearest 0.1 kg and should be measured in a fasting state. Height will be measured to the nearest 0.1 cm.

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

  4. Change in body composition

    In Index Parent(s) and Index Child(ren): Dual-energy X-ray absorptiometry and bioimpedance scans will be performed in fasting state to measure fat free mass and fat mass in kg.

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

  5. Change in waist-to-height ratio

    In Index Parent(s) and Index Child(ren): Waist circumference in cm divided by height in cm.

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

Other outcomes

  1. Change in glucose

    In Index Parent(s) and Index Child(ren): Glucose concentration will be assessed in fasting blood samples.

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

  2. Change in insulin

    In Index Parent(s) and Index Child(ren): Insulin concentration will be assessed in fasting blood samples.

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

  3. Change in C-peptide

    In Index Parent(s) and Index Child(ren): C-peptide concentration will be assessed in fasting blood samples.

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

  4. Change in proinsulin

    In Index Parent(s) and Index Child(ren): Proinsulin concentration will be assessed in fasting blood samples.

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

  5. Change in HbA1c

    In Index Parent(s) and Index Child(ren): HbA1c will be assessed in blood samples.

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

  6. Change in glucagon

    In Index Parent(s) and Index Child(ren): Glucagon concentration will be assessed in fasting blood samples.

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

  7. Change in GLP-1

    In Index Parent(s) and Index Child(ren): Glucagon-like peptide-1 concentration will be assessed in fasting blood samples.

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

  8. Change in GIP

    In Index Parent(s) and Index Child(ren): Glucose-dependent insulinotropic polypeptide concentration will be assessed in fasting blood samples.

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

  9. Change in indices of insulin sensitivity and resistance

    In Index Parent(s) and Index Child(ren): Indices of insulin sensitivity and resistance, including HOMA-IR, will be calculated from the relevant glycaemic-control measures.

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

  10. Change in Lipid Markers

    In Index Parent(s) and Index Child(ren): Lipid markers comprising total cholesterol, LDL, HDL, VLDL, triglycerides, free fatty acids, sphingolipids and lipidomic profiles.

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

  11. Change in Exploratory Metabolic Biomarkers

    In Index Parent(s) and Index Child(ren): Exploratory metabolic biomarkers comprising adiponectin, neurotensin, neprilysin, visfatin, resistin, PAPP-A, Pro-MBP, FGF21, GDF-15, N-lactoyl-phenylalanine, pigment epithelium-derived factor, chemerin, vaspin, irisin, and omentin.

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

  12. Change in prevalence of metabolic syndrome

    In Index Parent(s) and Index Child(ren): Metabolic syndrome prevalence (%)

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

  13. Change in metabolic-syndrome z-score

    In Index Parent(s) and Index Child(ren): Z-score

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

  14. Change in systolic and diastolic blood pressure

    In Index Parent(s) and Index Child(ren): Blood pressure profile comprising systolic and diastolic blood pressure (mmHg), measured in duplicate using a digital blood pressure monitor.

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

  15. Change in resting heart rate

    In Index Parent(s) and Index Child(ren): Resting heart rate (bpm) measured in duplicate using a digital blood pressure monitor.

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

  16. Change in circulating inflammatory markers

    In Index Parent(s) and Index Child(ren): Circulating inflammatory markers and endothelial markers (e.g., hsCRP, CRP, leucocytes, sCD163, MBL, Interferon-γ, IL-1, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, IL-1RaP, TNF-α, and endothelial markers, e.g., ICAM-1, VCAM-1, malonyldialdehyde, F2-Isoprostanes);

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

  17. Change in Circulating Sex hormones

    In Index Parent(s): Circulating Sex hormones (e.g. Total and free testosterone, derivates of testosterone, estradiol and derivates hereof, luteinizing hormone (LH), follicle stimulating hormone (FSH), sex hormone binding globulin (SHBG), and androstenedione, progesterone, dehydroepiandrosterone sulfate (DHEA S), anti Müllerian hormone (AMH), Inhibin B and albumin)

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

  18. Change in VO₂max

    In Index Parent(s): VO₂max will be assessed as a measure of cardiorespiratory fitness.

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

  19. Change in peak power output

    In Index Parent(s): Peak power output will be assessed during the cardiorespiratory fitness test.

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

  20. Change in one-repetition maximum leg-extension strength

    In Index Parent(s): Lower-limb muscle strength will be assessed as one-repetition maximum in the leg-extension test.

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

  21. Change in handgrip strength

    In Index Parent(s): Handgrip strength will be assessed using a handgrip-strength test.

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

  22. Change in sit-to-stand performance

    In Index Parent(s), Index Child(ren) and siblings: Functional muscle performance will be assessed using the sit-to-stand test.

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

  23. Change in stair-climbing performance

    In Index Parent(s), Index Child(ren) and siblings: Functional muscle performance will be assessed using a stair-climbing test.

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

  24. Change in 20-metre sprint performance

    In Index Child(ren) and siblings: Sprint performance will be assessed using a 20-metre sprint test.

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

  25. Change in standing long-jump performance

    In Index Child(ren) and siblings: Muscular fitness will be assessed using the standing long-jump test.

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

  26. Change in physical activity

    In Index Parent(s), Index Child(ren), other parents, and siblings: Physical activity will be assessed using accelerometry, wrist-worn activity monitors and questionnaires, including the International Physical Activity Questionnaire where applicable.

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

  27. Change in sedentary behaviour

    In Index Parent(s), Index Child(ren), other parents, and siblings: Sedentary behaviour will be assessed using accelerometry, wrist-worn activity monitors and questionnaires.

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

  28. To explore the feasibility and satisfaction of the Family Care

    In Index Parent(s) and Index Child(ren): Self-reported satisfaction with the app solution, retention and adherence rates, perceived usefulness of the intervention components (participant education, AI-assisted feedback, and online coaching) collected via qualitative interviews after eight weeks of online coaching.

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

  29. Change in health-related quality of life

    In Index Parent(s), other parents, Index Child(ren) and siblings: Health-related quality of life will be assessed using the SF-36.

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

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

    In the Families: Quality of life (QoL): Qualitative interviews exploring family experiences with the intervention and home environment factors influencing behaviours.

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

  31. Change in cognitive and motivational task profile

    In Index Parent(s) and Index Child(ren): Cognitive and motivational task profile comprising measures of inhibitory control using the Go/No-Go task and reward motivation using the Effort-Expenditure for Rewards Task.

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

  32. Change in self-efficacy

    In Index Parent(s) and other parents: Self-efficacy will be assessed using the General Self-Efficacy Scale.

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

  33. Change in well-being and quality of life

    In Index Child(ren) and siblings: Age-appropriate well-being and health-related quality of life will be assessed using KIDSCREEN.

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

  34. Change in psychosocial functioning

    In Index Child(ren) and siblings: Psychosocial functioning will be assessed using the Strengths and Difficulties Questionnaire.

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

  35. Change in Edmonton Obesity Staging System stage

    In Index Parent(s): Obesity-related health impairment will be assessed using the Edmonton Obesity Staging System. Higher stages indicate greater obesity-related health impairment and a worse outcome.

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

  36. Change in Edmonton Obesity Staging System for Pediatrics stage

    In Index Child(ren): Obesity-related health impairment will be assessed using the Edmonton Obesity Staging System for Pediatrics. Higher stages indicate greater obesity-related health impairment and a worse outcome.

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

  37. Change in liver-function biomarkers

    In Index Parent(s) and Index Child(ren): Liver-function biomarkers, including ALT, AST, fetuin-A and liver-expressed antimicrobial peptide 2, will be assessed in fasting blood samples.

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

  38. Change in pancreatic-function biomarkers

    In Index Parent(s) and Index Child(ren): Pancreatic-function biomarkers, including amylase, will be assessed in fasting blood samples.

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

  39. Change in renal-function and electrolyte biomarkers

    In Index Parent(s) and Index Child(ren): Renal-function and electrolyte biomarkers, including creatinine, estimated glomerular filtration rate, calcium, potassium, sodium, magnesium and urate, will be assessed in fasting blood samples.

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

  40. Change in haematological biomarkers

    In Index Parent(s) and Index Child(ren): Haematological biomarkers, including platelet count and haemoglobin, will be assessed in fasting blood samples.

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

  41. Change in coagulation and fibrinolysis biomarkers

    In Index Parent(s) and Index Child(ren): Coagulation and fibrinolysis biomarkers, including INR, tPA and vWF, will be assessed in fasting blood samples.

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

  42. Change in thyroid-function biomarkers

    In Index Parent(s) and Index Child(ren): Thyroid-function biomarkers, including TSH, T3, T4 and fT4, will be assessed in fasting blood samples.

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

  43. Change in bone mineral density

    In Index Parent(s) and Index Child(ren): Bone mineral density will be assessed by dual-energy X-ray absorptiometry.

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

  44. Change in circulating IGF-1

    In Index Child(ren): Circulating IGF-1 concentration will be assessed in fasting blood samples.

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

  45. Change in bone-health biomarkers

    In Index Parent(s) and Index Child(ren): Bone-health biomarkers, including calcium, alkaline phosphatase, vitamin D, PTH, sclerostin, osteocalcin, undercarboxylated osteocalcin, CTX and P1NP, will be assessed in fasting blood samples.

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

  46. Change in anthropometric measures of growth

    In Index Child(ren): Growth will be assessed using the anthropometric measurements pre-specified in the study protocol.

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

  47. Change in Tanner stage

    In Index Child(ren): Pubertal development will be assessed using Tanner staging.

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

  48. Change in dietary behaviours

    In Index Parent(s), Index Child(ren), other parents, and siblings: Dietary habits will be assessed using dietary records and food-frequency questionnaires.

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

  49. Change in eating behaviour

    In Index Parent(s), Index Child(ren), other parents, and siblings: Age-appropriate eating behaviour will be assessed using the Three-Factor Eating Questionnaire, Child Eating Behaviour Questionnaire or Adult Eating Behaviour Questionnaire, as applicable.

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

  50. Change in feeding practices

    In Parents: Feeding practices will be assessed using the Feeding Practices and Structure Questionnaire for Infants and Toddlers.

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

  51. Change in binge-eating symptoms

    In Index Parent(s): Binge-eating symptoms will be assessed using the BED-Q.

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

  52. Change in subjective appetite ratings

    In Index Parent(s) and Index Child(ren): Subjective appetite will be assessed using appetite-rating scales.

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

  53. Change in appetite-related biomarkers

    In Index Parent(s) and Index Child(ren): Appetite-related biomarkers, including leptin, soluble leptin receptor, bound leptin and GLP-1, ghrelin, pyy, pp will be assessed in fasting blood samples.

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

  54. Change in sleep duration

    In Index Parent(s), Index Child(ren), other parents and siblings: Sleep duration will be assessed using wearable-device measurements and a sleep diary.

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

  55. Change in sleep quality

    In Index Parent(s), Index Child(ren), other parents and siblings: Sleep quality will be assessed using wearable-device measurements, a sleep diary and age-appropriate questionnaires, including the Pittsburgh Sleep Quality Index, STOP-Bang Questionnaire and the Sleep Screening Questionnaire for Children and Adolescents.

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

  56. To explore the changes in faecal microbiome

    In Index Parent(s), other parents, Index Child(ren) and siblings: Faecal microbiome

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

  57. To explore the changes in urine metabolomics

    In Index Parent(s), other parents, Index Child(ren) and siblings: urine metabolomics

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

  58. Change in the Metabolomic Profile

    In Index Parent(s) and Index Child(ren): The metabolomic profile will be assessed in collected biological samples using the metabolomic analyses.

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

  59. Change in systemic levels of metabolic disruptors

    In Index Parent(s) and Index Child(ren): Plasma/serum concentrations of metabolic disruptors e.g. per- and polyfluorinated substances (PFAS).

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

  60. Change in cellular and genetic markers

    In Index Parent(s) and Index Child(ren): Change in cellular and genetic biomarkers assessed in peripheral blood mononuclear cells, genomic DNA, and induced pluripotent stem cell cultures derived from collected biological samples.

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

  61. Change in genomics profile

    In Index Parent(s) and Index Child(ren): Genomic analyses of blood-derived samples.

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

  62. Change in transcriptomics profiles

    In Index Parent(s) and Index Child(ren): Transcriptomic analyses of blood-derived samples.

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

  63. Follow-up health

    Changes in health markers will be compared between Enhanced Family Care, Family Care, Enhanced Standard Care and Standard Care.

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

07

Study locations

1 site
  • University of Copenhagen, Department of Biomedical Sciences
    Copenhagen, 2200, Denmark
08

References and documents

Publications

  • Ward ZJ, Long MW, Resch SC, Giles CM, Cradock AL, Gortmaker SL. Simulation of Growth Trajectories of Childhood Obesity into Adulthood. N Engl J Med. 2017 Nov 30;377(22):2145-2153. doi: 10.1056/NEJMoa1703860. PubMed 29171811 ↗
  • Geserick M, Vogel M, Gausche R, Lipek T, Spielau U, Keller E, Pfaffle R, Kiess W, Korner A. Acceleration of BMI in Early Childhood and Risk of Sustained Obesity. N Engl J Med. 2018 Oct 4;379(14):1303-1312. doi: 10.1056/NEJMoa1803527. PubMed 30281992 ↗
  • Hampl SE, Hassink SG, Skinner AC, Armstrong SC, Barlow SE, Bolling CF, Avila Edwards KC, Eneli I, Hamre R, Joseph MM, Lunsford D, Mendonca E, Michalsky MP, Mirza N, Ochoa ER, Sharifi M, Staiano AE, Weedn AE, Flinn SK, Lindros J, Okechukwu K. Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity. Pediatrics. 2023 Feb 1;151(2):e2022060640. doi: 10.1542/peds.2022-060640. No abstract available. PubMed 36622115 ↗
  • Mead E, Brown T, Rees K, Azevedo LB, Whittaker V, Jones D, Olajide J, Mainardi GM, Corpeleijn E, O'Malley C, Beardsmore E, Al-Khudairy L, Baur L, Metzendorf MI, Demaio A, Ells LJ. Diet, physical activity and behavioural interventions for the treatment of overweight or obese children from the age of 6 to 11 years. Cochrane Database Syst Rev. 2017 Jun 22;6(6):CD012651. doi: 10.1002/14651858.CD012651. PubMed 28639319 ↗
  • Epstein LH, Wilfley DE, Kilanowski C, Quattrin T, Cook SR, Eneli IU, Geller N, Lew D, Wallendorf M, Dore P, Paluch RA, Schechtman KB. Family-Based Behavioral Treatment for Childhood Obesity Implemented in Pediatric Primary Care: A Randomized Clinical Trial. JAMA. 2023 Jun 13;329(22):1947-1956. doi: 10.1001/jama.2023.8061. PubMed 37314275 ↗
  • McDarby F, Looney K. The effectiveness of group-based, parent-only weight management interventions for children and the factors associated with outcomes: a systematic review. Int J Obes (Lond). 2024 Jan;48(1):3-21. doi: 10.1038/s41366-023-01390-6. Epub 2023 Oct 11. PubMed 37821651 ↗
  • Jensen SBK, Blond MB, Sandsdal RM, Olsen LM, Juhl CR, Lundgren JR, Janus C, Stallknecht BM, Holst JJ, Madsbad S, Torekov SS. Healthy weight loss maintenance with exercise, GLP-1 receptor agonist, or both combined followed by one year without treatment: a post-treatment analysis of a randomised placebo-controlled trial. EClinicalMedicine. 2024 Feb 19;69:102475. doi: 10.1016/j.eclinm.2024.102475. eCollection 2024 Mar. PubMed 38544798 ↗
  • Lundgren JR, Janus C, Jensen SBK, Juhl CR, Olsen LM, Christensen RM, Svane MS, Bandholm T, Bojsen-Moller KN, Blond MB, Jensen JB, Stallknecht BM, Holst JJ, Madsbad S, Torekov SS. Healthy Weight Loss Maintenance with Exercise, Liraglutide, or Both Combined. N Engl J Med. 2021 May 6;384(18):1719-1730. doi: 10.1056/NEJMoa2028198. PubMed 33951361 ↗
  • Bogh AF, Jensen SBK, Juhl CR, Janus C, Sandsdal RM, Lundgren JR, Noer MH, Vu NQ, Fiorenza M, Stallknecht BM, Holst JJ, Madsbad S, Torekov SS. Insufficient sleep predicts poor weight loss maintenance after 1 year. Sleep. 2023 May 10;46(5):zsac295. doi: 10.1093/sleep/zsac295. PubMed 36472579 ↗

Individual participant data

Plan to share: Yes — Data sharing will be in accordance with EU and General Data Protection Regulation requirements and applicable local regulations, and in accordance with trial protocol and statistical analysis plan.

Supporting information: Study protocol, Statistical analysis plan

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07872904
Lead sponsor
Signe Torekov
Collaborators
Copenhagen University Hospital, Rigshospitalet, Hvidovre University Hospital, Herlev Hospital, Psychiatric Center Ballerup, The Research and Implementation Unit PROgrez, Region Zealand,Denmark, Sorbonne University, Mayo Clinic, Harvard University
Responsible party
Signe Torekov (Professor, University of Copenhagen) — Sponsor-investigator
First posted
Oct 14, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
May 31, 2030 (estimated)
Completion
Jan 31, 2031 (estimated)
Last update
Oct 14, 2026

Study contacts

Study Team
Contact
FutureShape@sund.ku.dk
+4593565828
Signe Torekov, Professor
Contact
torekov@sund.ku.dk
Signe Torekov, Professor
principal investigator · University of Copenhagen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Semaglutide

Other studies in this condition

Obesity →

Other studies from this sponsor

Signe Torekov

Start the discussion