Obesity Clinical Trial
— TOP12Official title:
Twelve-year Follow-up on the Treatment of Obese Pregnant Women (TOP) Study
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Steno Diabetes Center Copenhagen | Herlev |
Lead Sponsor | Collaborator |
---|---|
Steno Diabetes Center Copenhagen | Lund University, Rigshospitalet, Denmark, Statens Serum Institut, University of Copenhagen |
Denmark,
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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