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

Obesity Clinical Trial

— TOP12  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05446220
• Other study ID #: TOP12
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2023
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Steno Diabetes Center Copenhagen
• Contact: Kristina M Renault
• Phone: 20250677
• Email: kristina.martha.renault[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Lifestyle intervention
Dietary advise and/or advise on physical activity monitored by pedometer

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Copenhagen	Herlev

Sponsors (5)

Lead Sponsor	Collaborator
Steno Diabetes Center Copenhagen	Lund University, Rigshospitalet, Denmark, Statens Serum Institut, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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