PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - a Randomized Controlled Study in Copenhagen

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The study is a single site parallel randomized controlled study. The study will be assessing the effect of approximately 10% weight loss intervention vs a control group among healthy females/couples where the prospective mother is overweight or obese (BMI 27-45 kg/m\^2) and between 18-38 years. The investigators will recruit a total of 240 healthy females/couples who will be randomized 1:1 to either intervention or control, stratified according to maternal pre-pregnancy BMI. The overall objective is to test whether a comprehensive pre-conceptional parental weight loss intervention effectively reduces the risk of offspring overweight and adiposity and its complications compared to a control group. The investigators hypothesize that parental weight loss intervention, initiated before conception, will facilitate lower parental insulin resistance, inflammation, body weight and adiposity, incretin responses compared to usual care. For the offspring the investigators hypothesize that the intervention will reduce adverse pregnancy outcomes with a reduction in offspring neonatal adiposity, reduced risk of being born large for gestational age (LGA) and with lower BMI z-score at 18 months.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 38
Healthy Volunteers: t
View:

• Maternal pre-pregnancy BMI 27.0-44.9 kg/m\^2

• Maternal age range 18-38 years

• Connected to Hvidovre Hospital as place of birth or willing to change from other Hospitals in Region H to Hvidovre Hospital

• Not pregnant or breastfeeding

• Paternal pre-pregnancy BMI 18.5-44.9 kg/m\^2

• Paternal age range 18-55 years

• Biological father

• Planning pregnancy within 1 year

• Provided voluntary informed consent

• Danish or English speaking

• Intention to permit the planned offspring to participate in the follow-up study

• Able to store biological samples from the offspring at home in the freezer in a box given by the study personnel

Locations
Other Locations
Denmark
University of Copenhagen
RECRUITING
Frederiksberg
Contact Information
Primary
Faidon Magkos, PhD
fma@nexs.ku.dk
+4535333671
Backup
Malene Nygaard, MSC
nygaard@nexs.ku.dk
+45 35 32 02 66
Time Frame
Start Date: 2022-12-15
Estimated Completion Date: 2033-12-31
Participants
Target number of participants: 480
Treatments
Experimental: Intervention
Rapid moderate weight loss (approximately 10% of body weight at baseline over 8-10 weeks or BMI 23 kg/m\^2 is achieved) by very low-calorie diet (VLCD), reintroduction (4 weeks), weight loss maintenance until pregnancy (up to 12 months), and a high protein, high fiber diet during pregnancy (n=120 females/couples).
No_intervention: Standard of care
The control group will not receive any dietary advice prior to pregnancy. During pregnancy control subjects will receive dietary advice similar to the intervention group, i.e. a high protein, high fiber diet (n=120 females/couples).
Related Therapeutic Areas
Sponsors
Collaborators: University of Copenhagen, Department of Growth and Reproduction Rigshospitalet, Denmark, Dept. of Obstetrics and Gynecology, Hvidovre Hospital, Denmark, Center for Healthy Childhood, Denmark
Leads: Christian Mølgaard

This content was sourced from clinicaltrials.gov