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

Steno Diabetes Centers

Status: Enrolling

Conditions: Pregnancy Related; Overweight and Obesity

Treatments: Behavioral: Diet; Behavioral: Mentorship; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05578690

H-22011403

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

Lifestyle group

Experimental group

Description:

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.

Treatment:

Behavioral: Mentorship

Behavioral: Exercise

Behavioral: Diet

Standard of care group

No Intervention group

Description:

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.