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

Not Applicable

Recruiting

• Conditions: Physical Activity; Lifestyle, Healthy; Follow-up; Body Composition; Gestational Weight Gain; Obesity; Diet, Healthy
• Interventions: Behavioral: Lifestyle intervention

• Registration Number: NCT05446220
• Lead Sponsor: Steno Diabetes Center Copenhagen

Brief 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.

Study Timeline

• Study First Submitted: 2022-07-01
• Study First Submitted QC: 2022-07-01
• Study First Posted: 2022-07-06
• Study Start: 2023-01-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• Participants/mothers in the initial TOP study will be invited with their offspring born following the pregnancy during the initial study to the 12-year follow-up study

Exclusion Criteria

• There are no exclusion criteria as the potential study population has already been selected at the baseline study in 2009-2012

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet + physical activity	Lifestyle intervention	Dietary advise and advise on physical activity monitored by pedometer
Physical activity	Lifestyle intervention	Advise on physical activity monitored by pedometer

Primary Outcome Measures

Name	Time	Method
Body composition	2 years data collection	Fatt mass index offspring, DXA scan + BMI mothers

Secondary Outcome Measures

Name	Time	Method
Liver stiffness	2 years data collection	FibroScan
Lung function	2 years data collection	Spirometry assessing FVC and FEV1
Large artery stiffness	2 years data collection	SphygmoCor examination
Eye examination	2 years data collection	OPTOS
Blood pressure	2 years data collection	Standardized sitting measurement of systolic and diastolic blood pressure, average of 3 measures
Relative fitness level	2 years data collection	Estimated relative fitness level assessed by a submaximal step test (The Danish Step Test)
Sex hormones	2 years data collection	Analyses of blood samples, children
Metabolic and inflammatory markers	2 years data collection	Analyses of blood samples
Mental health	2 years data collection	Assessed by questionnaires, validated to mother and child respectively
Glycemic variability	2 years data collection	CGM measures
Diet composition	2 years data collection	Assessed by FFQ (food frequency questionnaire), validated to mother and child respectively
Level and pattern of physical activity	2 years data collection	Assessed by activity tracker worn on the rist for 7 days + IPAQ short (International physical activity questionnaire)
Epigenetic examinations	2 years data collection	Epigenetic examinations
Puberty stage	2 years data collection	According to the classifications of Marshall and Tanner

Trial Locations

Locations (1)

Steno Diabetes Center Copenhagen; 🇩🇰 Herlev, Denmark