NCT05446220

Twelve-year Follow-up on the Treatment of Obese Pregnant Women (TOP) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 497 (actual)
• Sponsor: Steno Diabetes Center Copenhagen · Academic / Other
• Sex: All
• Age: 12 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The participant (both mother and child) in the initial TOP study will be invited to a follow-up study to evaluate the effect of life style intervention during pregnancy on both mother and their offspring 12 years after the intervention. The study will contribute to understanding the transfer of obesity between generations and how to treat as well as prevent obesity.

Detailed description

The initial study (Treatment of Obese Pregnant women (TOP) study) was performed at Hvidovre Hospital, University of Copenhagen in 2009-12 and included 425 pregnant women with pre-gestational BMI ≥ 30kg/m2 in gestational week 11-14. They were randomized 1:1:1 into: 1) a low-calorie Mediterranean-style diet and pedometer assisted physical activity (PA) intervention 2) a pedometer assisted PA intervention alone or 3) no intervention (control). Primary outcome was gestational weight gain (GWG). 389 women completed the study. The participants (both mother and child in pair) who completed the initial TOP study will be invited to a 3-hour examination now 12 years after the intervention during pregnancy to evaluate the effect of the intervention on both mother and child long term.

Conditions

• Obesity
• Lifestyle, Healthy
• Diet, Healthy
• Follow-up
• Physical Activity
• Body Composition
• Gestational Weight Gain

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle intervention	Dietary advise and/or advise on physical activity monitored by pedometer

Timeline

• Start date: 2023-01-05
• Primary completion: 2025-09-26
• Completion: 2025-09-26
• First posted: 2022-07-06
• Last updated: 2025-11-21

Locations

1 site across 1 country: Denmark