Healthy Lifestyle Before and During Pregnancy to Prevent Childhood Obesity - the PRE-STORK-trial

NCT ID: NCT05578690

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-26
• Study Completion Date: 2029-07-31

Brief Summary

Introduction: The prevalence of childhood overweight and obesity has risen from just 4% in 1975 to more than 18% in 2016. Little is known about adiposity of the infant, but it positively associates to the mother's BMI. Globally, the prevalence of overweight has tripled since 1975 and is now affecting one of three Danish women at the time of pregnancy. However, despite increasing awareness of obesity and accumulating evidence of its health consequences limited effect of intervention in childhood obesity exists. Maternal obesity before conception, an excessive increase in body weight during pregnancy and physical inactivity are some of the risk factors suspected of infant adiposity. Lifestyle interventions during pregnancy have shown limited or no effect in the offspring. Therefore, renewed effort to improve the prevention of childhood obesity is warranted.

Methods and analysis: This is a randomized, parallel group, tailored, multifactorial lifestyle intervention trial in women (age 18 to 38 years) with overweight or obesity (BMI 27 to 42 kg/m2) seeking pregnancy. The women are randomized 1:1 to either the lifestyle or standard of care group. The lifestyle intervention is initiated prior to pregnancy. The lifestyle intervention is set off with a low-calorie diet for 8 weeks and throughout the intervention period (prior to and during pregnancy) participants follow an intervention containing exercise according to the World Health Organization guidelines, healthy diet and mentorship to maintain healthy weight before and during pregnancy.The primary outcome is the difference in neonatal adiposity measured at birth. Finally, a child and family cohort will be established to follow the children throughout childhood for healthy weight development. The study will provide evidence of effects from pre-conception-initiated intervention and have the potential to improve health and quality of life for children.

Ethics and dissemination: The trial has been approved by the ethical committee of the Capital Region of Denmark (H-22011403) The trial will be conducted in agreement with the Declaration of Helsinki and monitored to follow the guidelines for good clinical practice. Results will be submitted for publication in international peer-reviewed scientific journals.

Conditions

Overweight and Obesity; Pregnancy Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Lifestyle group

A tailored multifactorial lifestyle intervention consisting of diet, exercise and mentorship in women with overweight or obesity to obtain a healthy lifestyle before and during pregnancy.

Group Type: EXPERIMENTAL

Diet

Intervention Type: BEHAVIORAL

An initial 8 weeks of low-calorie diet including meal replacements (total of 800 kcal/day) will be initiated with the objective to lose at least 10% of initial body weight. From week 8 until week 12, an individual food-reintroduction plan will take place with partial meal product substitution. At week 12 and until pregnancy dieticians will ensure sustained compliance with diet aligned with the general recommendations for women seeking pregnancy (low-fat diet, rich in protein and carbohydrates and in some individuals slightly carbohydrate-reduced diet (prediabetes or family disposition to diabetes) with focus on carbohydrate quality (more fiber and whole grain). Consultations with a dietician for mapping diet and eating patterns and regular follow-up with a dietitian to maintain diet changes and modify diets if needed.

Exercise

Intervention Type: BEHAVIORAL

After an initial 8-week ramp-up phase (during the initial low-calorie diet), the women will be encouraged to attend supervised exercise sessions on the study location (combination of vigorous-intensity, interval-based indoor cycling, and circuit training) twice weekly and to perform additional moderate-to vigorous-intensity exercise to obtain at least 150 min per week of moderate-intensity or 75 min per week of vigorous-intensity physical activity or a combination. The plan will include individual exercise and/or group exercise. Exercise watches with heart-rate monitors will be worn at each exercise session to determine whether the requirement regarding weekly time spent at moderate or vigorous intensity will be met. Regular follow-up with the women to maintain exercise changes and modify the exercise plan if needed.

Mentorship

Intervention Type: BEHAVIORAL

Women are offered an individualized plan to successfully fulfil the multifactorial lifestyle intervention and the women will be offered both individual and/or group sessions with a mentor. After 8 weeks of the intervention, the women will be invited to another meeting where the choice of mentor will be evaluated, and the women will be offered to join a "pre-parents-group". Group sessions will include conversational sessions, cooking classes and exercise classes with focus on changing lifestyle and maintaining a healthy lifestyle change. At the time of pregnancy groups will be reconsidered and the women will be offered participation in "pregnancy-groups".

Standard of care group

The standard of care group will receive no active intervention but are encouraged to seek any possible guidance from the general practitioner for management of pre-pregnancy obesity according to current guidelines.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Diet

An initial 8 weeks of low-calorie diet including meal replacements (total of 800 kcal/day) will be initiated with the objective to lose at least 10% of initial body weight. From week 8 until week 12, an individual food-reintroduction plan will take place with partial meal product substitution. At week 12 and until pregnancy dieticians will ensure sustained compliance with diet aligned with the general recommendations for women seeking pregnancy (low-fat diet, rich in protein and carbohydrates and in some individuals slightly carbohydrate-reduced diet (prediabetes or family disposition to diabetes) with focus on carbohydrate quality (more fiber and whole grain). Consultations with a dietician for mapping diet and eating patterns and regular follow-up with a dietitian to maintain diet changes and modify diets if needed.

Intervention Type: BEHAVIORAL

Exercise

After an initial 8-week ramp-up phase (during the initial low-calorie diet), the women will be encouraged to attend supervised exercise sessions on the study location (combination of vigorous-intensity, interval-based indoor cycling, and circuit training) twice weekly and to perform additional moderate-to vigorous-intensity exercise to obtain at least 150 min per week of moderate-intensity or 75 min per week of vigorous-intensity physical activity or a combination. The plan will include individual exercise and/or group exercise. Exercise watches with heart-rate monitors will be worn at each exercise session to determine whether the requirement regarding weekly time spent at moderate or vigorous intensity will be met. Regular follow-up with the women to maintain exercise changes and modify the exercise plan if needed.

Intervention Type: BEHAVIORAL

Mentorship

Women are offered an individualized plan to successfully fulfil the multifactorial lifestyle intervention and the women will be offered both individual and/or group sessions with a mentor. After 8 weeks of the intervention, the women will be invited to another meeting where the choice of mentor will be evaluated, and the women will be offered to join a "pre-parents-group". Group sessions will include conversational sessions, cooking classes and exercise classes with focus on changing lifestyle and maintaining a healthy lifestyle change. At the time of pregnancy groups will be reconsidered and the women will be offered participation in "pregnancy-groups".

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Having overweight or obesity (BMI 25-44 kg/m2)
• Age 18-34 years (no previous pregnancy) or 18-40 years (previous pregnant >16 weeks)
• Planning a pregnancy within the next year
• Willingness to lose at least 10% of initial body weight before pregnancy and be physically able to adhere to WHO physical activity recommendations when entering the study
• Willing to postpone pregnancy until at least 6 months after randomization
• Planning antenatal care and delivery at either Herlev Hospital or Odense University Hospital
• Danish or English speaking

Exclusion Criteria

• Diabetes (fasting plasma glucose (FPG) >7 mmol/l and HbA1c ≥48 mmol/mol)
• Previous gestational diabetes mellitus (GDM) treated with insulin during pregnancy
• Polycystic ovary syndrome (PCOS) treated with metformin
• Treatment with medication which significantly affect glucose metabolism, appetite, or energy balance
• The use of medications that cause clinically significant weight gain or loss
• Habitual abortion (more than 3 abortions in a row)
• Known infertility (defined as fertility treatment and/or no obtained conception with the same partner after trying >12 months)
• Previous bariatric surgery
• Significant psychiatric disorders
• Uncontrolled/severe medical issues including cardiovascular, pulmonary, rheumatologic, hematologic, oncologic, infectious, or endocrine disease
• Regular exercise training at high intensity (e.g., spinning) >3 hours per week
• Known eating disorder

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tina Vilsbøll, Professor

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center Copenhagen

Louise G. Grunnet, PhD

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center Copenhagen

Signe Torekov, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

Steno Diabetes Center Copenhagen

Herlev, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Louise G Grunnet, PhD

Role: CONTACT

louise.groth.grunnet.02@regionh.dk

0045 60671704

Tina Vilsbøll, Professor

Role: CONTACT

tina.vilsboell.01@regionh.dk

0045 40940825

Facility Contacts

Mette Y. Johansen, PhD

Role: primary

mette.yun.johansen.01@regionh.dk

0045 29269116

Tina Vilsbøll, Professor

Role: backup

tina.vilsboell.01@regionh.dk

0045 40940825

References

Kornerup N, Danielsen JH, Sahl RE, Pico ML, Johansen MY, Knop FK, Bonnelykke K, Bergholt T, Kelstrup L, Foghsgaard S, Ghauri N, Gronlund E, Lund L, Vinter CA, Lyng Forman J, Barres R, Kragelund Nielsen K, Andersen A, Torekov SS, Groth Grunnet L, Vilsboll T. Healthy lifestyle before and during pregnancy to prevent childhood obesity: study protocol for a parallel group randomised trial - the PRE-STORK trial. BMJ Open. 2025 Jan 25;15(1):e087895. doi: 10.1136/bmjopen-2024-087895.

Reference Type: DERIVED

PMID: 39863406 (View on PubMed)

Other Identifiers

H-22011403

Identifier Type: -

Identifier Source: org_study_id