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

Primary Purpose

Obesity, Lifestyle, Healthy, Diet, Healthy

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Lifestyle intervention
Sponsored by
Steno Diabetes Center Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Steno Diabetes Center CopenhagenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Diet + physical activity

Physical activity

Control

Arm Description

Dietary advise and advise on physical activity monitored by pedometer

Advise on physical activity monitored by pedometer

No intervention

Outcomes

Primary Outcome Measures

Body composition
Fatt mass index offspring, DXA scan + BMI mothers

Secondary Outcome Measures

Metabolic and inflammatory markers
Analyses of blood samples
Blood pressure
Standardized sitting measurement of systolic and diastolic blood pressure, average of 3 measures
Glycemic variability
CGM measures
Mental health
Assessed by questionnaires, validated to mother and child respectively
Diet composition
Assessed by FFQ (food frequency questionnaire), validated to mother and child respectively
Level and pattern of physical activity
Assessed by activity tracker worn on the rist for 7 days + IPAQ short (International physical activity questionnaire)
Relative fitness level
Estimated relative fitness level assessed by a submaximal step test (The Danish Step Test)
Epigenetic examinations
Epigenetic examinations
Liver stiffness
FibroScan
Lung function
Spirometry assessing FVC and FEV1
Large artery stiffness
SphygmoCor examination
Eye examination
OPTOS
Sex hormones
Analyses of blood samples, children
Puberty stage
According to the classifications of Marshall and Tanner

Full Information

First Posted
July 1, 2022
Last Updated
February 2, 2023
Sponsor
Steno Diabetes Center Copenhagen
Collaborators
Rigshospitalet, Denmark, Statens Serum Institut, Lund University, University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT05446220
Brief Title
Twelve-year Follow-up on the Treatment of Obese Pregnant Women (TOP) Study
Acronym
TOP12
Official Title
Twelve-year Follow-up on the Treatment of Obese Pregnant Women (TOP) Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Steno Diabetes Center Copenhagen
Collaborators
Rigshospitalet, Denmark, Statens Serum Institut, Lund University, University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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 treat as well as prevent obesity.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Lifestyle, Healthy, Diet, Healthy, Follow-up, Physical Activity, Body Composition, Gestational Weight Gain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Follow-up study on healthy lifestyle intervention during pregnancy (randomized controlled trial - TOP study) 12 years after the intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diet + physical activity
Arm Type
Experimental
Arm Description
Dietary advise and advise on physical activity monitored by pedometer
Arm Title
Physical activity
Arm Type
Experimental
Arm Description
Advise on physical activity monitored by pedometer
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
Intervention Description
Dietary advise and/or advise on physical activity monitored by pedometer
Primary Outcome Measure Information:
Title
Body composition
Description
Fatt mass index offspring, DXA scan + BMI mothers
Time Frame
2 years data collection
Secondary Outcome Measure Information:
Title
Metabolic and inflammatory markers
Description
Analyses of blood samples
Time Frame
2 years data collection
Title
Blood pressure
Description
Standardized sitting measurement of systolic and diastolic blood pressure, average of 3 measures
Time Frame
2 years data collection
Title
Glycemic variability
Description
CGM measures
Time Frame
2 years data collection
Title
Mental health
Description
Assessed by questionnaires, validated to mother and child respectively
Time Frame
2 years data collection
Title
Diet composition
Description
Assessed by FFQ (food frequency questionnaire), validated to mother and child respectively
Time Frame
2 years data collection
Title
Level and pattern of physical activity
Description
Assessed by activity tracker worn on the rist for 7 days + IPAQ short (International physical activity questionnaire)
Time Frame
2 years data collection
Title
Relative fitness level
Description
Estimated relative fitness level assessed by a submaximal step test (The Danish Step Test)
Time Frame
2 years data collection
Title
Epigenetic examinations
Description
Epigenetic examinations
Time Frame
2 years data collection
Title
Liver stiffness
Description
FibroScan
Time Frame
2 years data collection
Title
Lung function
Description
Spirometry assessing FVC and FEV1
Time Frame
2 years data collection
Title
Large artery stiffness
Description
SphygmoCor examination
Time Frame
2 years data collection
Title
Eye examination
Description
OPTOS
Time Frame
2 years data collection
Title
Sex hormones
Description
Analyses of blood samples, children
Time Frame
2 years data collection
Title
Puberty stage
Description
According to the classifications of Marshall and Tanner
Time Frame
2 years data collection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina M Renault
Phone
20250677
Email
kristina.martha.renault@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Sidsel S Gertsen
Phone
28498450
Email
sidsel.seide.gertsen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina M Renault
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steno Diabetes Center Copenhagen
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sidsel S Gertsen
Phone
20530492
Email
sidsel.seide.gertsen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Anna A Jepsen
Phone
20530492
Email
anna.amalia.jepsen@regionh.dk

12. IPD Sharing Statement

Learn more about this trial

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

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