NCT05446220

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
497

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

January 5, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2025

Completed
Last Updated

November 21, 2025

Status Verified

August 1, 2025

Enrollment Period

2.7 years

First QC Date

July 1, 2022

Last Update Submit

November 18, 2025

Conditions

ObesityLifestyle, HealthyDiet, HealthyFollow-upPhysical ActivityBody CompositionGestational Weight Gain

Outcome Measures

Primary Outcomes (1)

  • Body composition

    Fatt mass index offspring, DXA scan + BMI mothers

    2 years data collection

Secondary Outcomes (14)

  • Metabolic and inflammatory markers

    2 years data collection

  • Blood pressure

    2 years data collection

  • Glycemic variability

    2 years data collection

  • Mental health

    2 years data collection

  • Diet composition

    2 years data collection

  • +9 more secondary outcomes

Study Arms (3)

Diet + physical activity

EXPERIMENTAL

Dietary advise and advise on physical activity monitored by pedometer

Behavioral: Lifestyle intervention

Physical activity

EXPERIMENTAL

Advise on physical activity monitored by pedometer

Behavioral: Lifestyle intervention

Control

NO INTERVENTION

No intervention

Interventions

Lifestyle interventionBEHAVIORAL

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

Diet + physical activityPhysical activity

Eligibility Criteria

Age12 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

ObesityMotor ActivityGestational Weight Gain

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorWeight GainBody Weight Changes

Study Officials

  • Kristina M Renault

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Follow-up study on healthy lifestyle intervention during pregnancy (randomized controlled trial - TOP study) 12 years after the intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2022

First Posted

July 6, 2022

Study Start

January 5, 2023

Primary Completion

September 26, 2025

Study Completion

September 26, 2025

Last Updated

November 21, 2025

Record last verified: 2025-08

Locations

DK(1)