TOP12: Twelve-year Follow-up on the Treatment of Obese Pregnant Women (TOP) Study

• Sponsor: Steno Diabetes Center Copenhagen (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05446220
• Collaborator: Rigshospitalet, Denmark (Other), Statens Serum Institut (Other), Lund University (Other), University of Copenhagen (Other)
• Enrollment: 600
• Arms: 3
• Anticipated Duration (Months): 25

Study Details

Study Description

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 prevent obesity.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Lifestyle, Healthy; Diet, Healthy; Follow-up; Physical Activity; Body Composition; Gestational Weight Gain	Behavioral: Healthy lifestyle intervention	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Follow-up study on healthy lifestyle intervention during pregnancy (randomized controlled trial - TOP study) 12 years after the intervention.Follow-up study on healthy lifestyle intervention during pregnancy (randomized controlled trial - TOP study) 12 years after the intervention.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Twelve-year Follow-up on the Treatment of Obese Pregnant Women (TOP) Study
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diet + physical activity Dietary advise and advise on physical activity monitored by pedometer	Behavioral: Healthy lifestyle intervention; Dietary advise and advise on physical activity monitored by pedometer
Experimental: Physical activity Advise on physical activity monitored by pedometer	Behavioral: Healthy lifestyle intervention; Dietary advise and advise on physical activity monitored by pedometer
No Intervention: Control No intervention

Outcome Measures

Primary Outcome Measures

1. Body composition [2 years data collection]

   Fatt mass index offspring, DXA scan

Secondary Outcome Measures

1. Metabolic and inflammatory markers [2 years data collection]

   Analyses of blood samples

2. Glycemic variability [2 years data collection]

   CGM measures

3. Mental health [2 years data collection]

   Assessed by questionnaires, validated to mother and child respectively

4. Diet composition [2 years data collection]

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

5. Level and pattern of physical activity [2 years data collection]

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

6. Epigenetic examinations [2 years data collection]

   Epigenetic examinations

7. Liver stiffness [2 years data collection]

   FibroScan

8. Large artery stiffness [2 years data collection]

   SphygmoCor examination

9. Lung function [2 years data collection]

   Spirometry

10. Eye examination [2 years data collection]

    OPTOS

11. Sex hormones [2 years data collection]

    Analyses of blood samples, children

12. Puberty stage [2 years data collection]

    According to the classifications of Marshall and Tanner

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Steno Diabetes Center Copenhagen
• Rigshospitalet, Denmark
• Statens Serum Institut
• Lund University
• University of Copenhagen

Investigators

• Principal Investigator: Kristina M Renault, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Steno Diabetes Center Copenhagen
• ClinicalTrials.gov Identifier: NCT05446220
• Other Study ID Numbers: TOP12
• First Posted: Jul 6, 2022
• Last Update Posted: Jul 6, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Weight Gain; Gestational Weight Gain

Study Results

No Results Posted as of Jul 6, 2022