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

NARecruitingINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

October 26, 2022

Primary Completion Date

July 31, 2029

Study Completion Date

July 31, 2029

Conditions
Overweight and ObesityPregnancy Related
Interventions
BEHAVIORAL

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.

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.

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."

Trial Locations (1)

2730

RECRUITING

Steno Diabetes Center Copenhagen, Herlev

All Listed Sponsors
collaborator

University of Copenhagen

OTHER

lead

Steno Diabetes Center Copenhagen

OTHER