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

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 a 10% pre-conceptional weight loss intervention vs a control group among healthy couples where the prospective mother is pregnant and overweight or obese (BMI 27-44.9 kg/m\^2). The couples in intervention group will receive dietitian counseling and participate in physical activity sessions to attain the 10% weight loss. 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.

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 Aarhus University Hospital as place of birth

• Pregnant

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

• Paternal age range 18-55 years

• Couples (male and female)

• Planning pregnancy within 3 years

• 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
Aarhus University Hospital
RECRUITING
Aarhus
Contact Information
Primary
Ulla K Opstrup, MD, PhD
ullaopst@rm.dk
+4522370857
Backup
Louise Rasmussen, MSc
louisesuder@clin.au.dk
+4528731648
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2028-04-11
Participants
Target number of participants: 140
Treatments
Experimental: Intervention
Intervention group will receive dietary counseling by a trained dietitian from 3 months post-partum of the 1st child until birth of the 2nd child. The mother will receive advice to provide a moderate caloric restriction (-500 to 1000 kcal/d) and attend physical activity sessions to attain a 10 % weight loss according to pre-pregnancy weight. If the father is also overweight or obese, he will receive the same advice.
No_intervention: Control
The control group will receive standard care and will not receive any dietary advice prior to pregnancy. During pregnancy control subjects will receive dietary advice according to standard care which means no counselling from a dietitian unless there are special needs (e.g., gestational diabetes), then they will receive counseling from a dietitian in accordance with standard care.
Related Therapeutic Areas
Sponsors
Collaborators: Per Ovesen, Professor Dept. of Obsteterics, Aarhus University Hospital, Sine Knorr, PhD Steno Diabetes Center Aarhus, Aarhus University Hospital, Jens Meldgaard Bruun, Professor Steno Diabetes Center Aarhus, Aarhus University Hospital
Leads: Ulla Kampmann Opstrup

This content was sourced from clinicaltrials.gov