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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05446220
Other study ID # TOP12
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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