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

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.

Conditions

• Overweight and Obesity
• Weight Loss
• Pregnancy Related
• Child Nutrition Sciences
• Body Composition

Interventions

BEHAVIORAL

Weight loss intervention

Subjects will receive dietary counseling by a dietitian from 3 months post-partum of the 1st child until birth of the 2nd child. The mother (and father if overweight, BMI ≥25 kg/m\^2) will receive advice to provide a moderate caloric restriction (-500 to 1000 kcal/d) and power walk 2-4 times a week for a half an hour and attend physical activity sessions every 2nd week to attain a minimum weight loss of approximately 0,5-1,0 kg/week. The weight loss will last until a 10% weight loss (according to pre-pregnancy weight) has been achieved or until 1-year post-partum. If the subject has not achieved a weight loss of 10%, she or he will receive Very low-calorie diet (VLCD) until target weight loss is reached, though no longer than 8 weeks. After weight loss subjects will receive counseling to maintain weight loss and healthy weight gain during pregnancy until birth of the 2nd child.

Sponsors & Collaborators

• Per Ovesen, Professor Dept. of Obsteterics, Aarhus University Hospital

  collaborator UNKNOWN

• Jens Meldgaard Bruun, Professor Steno Diabetes Center Aarhus, Aarhus University Hospital

  collaborator UNKNOWN

• Sine Knorr, PhD Steno Diabetes Center Aarhus, Aarhus University Hospital

  collaborator UNKNOWN

• Ulla Kampmann Opstrup

  lead OTHER

Principal Investigators

• Ulla K Opstrup, Assoc · Aarhus University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

38 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-06-01

Primary Completion

2025-04-11

Completion

2028-04-11

Countries

• Denmark

Study Locations