PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Copenhagen

NARecruitingINTERVENTIONAL
Enrollment

480

Participants

Timeline

Start Date

December 15, 2022

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2033

Conditions
Overweight and ObesityWeight LossPregnancy Related
Interventions
BEHAVIORAL

Weight loss intervention

"Subjects will receive very low-calorie diet for 8-10 weeks to introduce a rapid weight loss of approximately 10%. Once target weight is achieved, participants will be reintroduced to foods to introduce weight stability.~The male will follow the maternal randomization, i.e. weight loss if BMI ≥25 until a BMI of 23 or a weight loss of approximately 10% is obtained.~During weight loss maintenance, subjects will receive dietary counseling to follow a diet high in protein (corresponding to 22-25E%), high fiber and wholegrain while fulfilling the requirements for essential fatty acids, micronutrients and trace elements in accordance with Nordic Nutrition Recommendations (NNR) 2012.~Throughout the study period participants will be encouraged to follow the official recommendations for physical activity as recommended by the Danish health authorities 2022."

Trial Locations (1)

1958

RECRUITING

University of Copenhagen, Frederiksberg

All Listed Sponsors
collaborator

Dept. of Obstetrics and Gynecology, Hvidovre Hospital, Denmark

UNKNOWN

collaborator

Department of Growth and Reproduction Rigshospitalet, Denmark

UNKNOWN

collaborator

Center for Healthy Childhood, Denmark

UNKNOWN

collaborator

University of Copenhagen

OTHER

lead

Christian Mølgaard

OTHER

NCT05621109 - PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Copenhagen | Biotech Hunter | Biotech Hunter