Skip to main content
OpenTrials
Completed

NCT Number: NCT05446220

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Behavior Body Composition Body Weight Body Weight Changes Diet, Healthy Follow-up Gestational Weight Gain Lifestyle, Healthy Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms Weight Gain

Age range

12 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Intervention

Behavioral

Dietary advise and/or advise on physical activity monitored by pedometer

Primary outcomes

  1. Body composition

    Time frame: 2 years data collection

    Fatt mass index offspring, DXA scan + BMI mothers

Secondary outcomes

  1. Metabolic and inflammatory markers

    Time frame: 2 years data collection

    Analyses of blood samples

  2. Blood pressure

    Time frame: 2 years data collection

    Standardized sitting measurement of systolic and diastolic blood pressure, average of 3 measures

  3. Glycemic variability

    Time frame: 2 years data collection

    CGM measures

  4. Mental health

    Time frame: 2 years data collection

    Assessed by questionnaires, validated to mother and child respectively

  5. Diet composition

    Time frame: 2 years data collection

    Assessed by FFQ (food frequency questionnaire), validated to mother and child respectively

  6. Level and pattern of physical activity

    Time frame: 2 years data collection

    Assessed by activity tracker worn on the rist for 7 days + IPAQ short (International physical activity questionnaire)

  7. Relative fitness level

    Time frame: 2 years data collection

    Estimated relative fitness level assessed by a submaximal step test (The Danish Step Test)

  8. Epigenetic examinations

    Time frame: 2 years data collection

    Epigenetic examinations

  9. Liver stiffness

    Time frame: 2 years data collection

    FibroScan

  10. Lung function

    Time frame: 2 years data collection

    Spirometry assessing FVC and FEV1

  11. Large artery stiffness

    Time frame: 2 years data collection

    SphygmoCor examination

  12. Eye examination

    Time frame: 2 years data collection

    OPTOS

  13. Sex hormones

    Time frame: 2 years data collection

    Analyses of blood samples, children

  14. Puberty stage

    Time frame: 2 years data collection

    According to the classifications of Marshall and Tanner

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Collaborators

  • Lund University
  • Rigshospitalet, Denmark
  • Statens Serum Institut
  • University of Copenhagen

Registry information

Acronym: TOP12

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 6, 2022
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.