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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Physical Activity; Body Composition; Diet, Healthy; Gestational Weight Gain; Lifestyle, Healthy; Follow-up
• Intervention / Treatment: Behavioral: Lifestyle intervention

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 Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristina M Renault; Phone Number: 20250677; Email: kristina.martha.renault@regionh.dk
• Study Contact Backup: Name: Sidsel S Gertsen; Phone Number: 28498450; Email: sidsel.seide.gertsen@regionh.dk

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Recruiting
    • Steno Diabetes Center Copenhagen
    • Contact: Sidsel S Gertsen; Phone Number: 20530492; Email: sidsel.seide.gertsen@regionh.dk
    • Contact: Anna A Jepsen; Phone Number: 20530492; Email: anna.amalia.jepsen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Fatt mass index offspring, DXA scan + BMI mothers	2 years data collection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic and inflammatory markers	Analyses of blood samples	2 years data collection
Glycemic variability	CGM measures	2 years data collection
Mental health	Assessed by questionnaires, validated to mother and child respectively	2 years data collection
Diet composition	Assessed by FFQ (food frequency questionnaire), validated to mother and child respectively	2 years data collection
Epigenetic examinations	Epigenetic examinations	2 years data collection
Liver stiffness	FibroScan	2 years data collection
Large artery stiffness	SphygmoCor examination	2 years data collection
Eye examination	OPTOS	2 years data collection
Sex hormones	Analyses of blood samples, children	2 years data collection
Puberty stage	According to the classifications of Marshall and Tanner	2 years data collection
Blood pressure	Standardized sitting measurement of systolic and diastolic blood pressure, average of 3 measures	2 years data collection
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
Relative fitness level	Estimated relative fitness level assessed by a submaximal step test (The Danish Step Test)	2 years data collection
Lung function	Spirometry assessing FVC and FEV1	2 years data collection

Collaborators and Investigators

• Sponsor: Steno Diabetes Center Copenhagen
• Collaborators: Lund University; Rigshospitalet, Denmark; University of Copenhagen; Statens Serum Institut
• Investigators: Principal Investigator: Kristina M Renault, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain; Gestational Weight Gain
• Other Study ID Numbers: TOP12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No