ObesityTOP12NCT05446220
Twelve-year Follow-up on the Treatment of Obese Pregnant Women (TOP) Study
A study testing Lifestyle intervention in people with Obesity and Lifestyle, Healthy, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Lifestyle, Healthy, Diet, Healthy
- What is being tested?
- Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 497 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Jan 2023to 26 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- There are no exclusion criteria as the potential study population has already been selected at the baseline study in 2009-2012
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Obesity, Lifestyle, Healthy, Diet, Healthy, Follow-up, Physical Activity, Body Composition
- Being tested
- Lifestyle intervention
- Medical subject headings
- Obesity, Motor Activity, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
Dietary advise and/or advise on physical activity monitored by pedometer
| Study group | Role | What they receive |
|---|---|---|
| Diet + physical activity | Experimental | Dietary advise and advise on physical activity monitored by pedometer Receives: Behavioral: Lifestyle intervention |
| Physical activity | Experimental | Advise on physical activity monitored by pedometer Receives: Behavioral: Lifestyle intervention |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Fatt mass index offspring, DXA scan + BMI mothers
Measured: 2 years data collection
Secondary outcomes (14)
Metabolic and inflammatory markers
Analyses of blood samples
Measured: 2 years data collection
Blood pressure
Standardized sitting measurement of systolic and diastolic blood pressure, average of 3 measures
Measured: 2 years data collection
Glycemic variability
CGM measures
Measured: 2 years data collection
Mental health
Assessed by questionnaires, validated to mother and child respectively
Measured: 2 years data collection
Diet composition
Assessed by FFQ (food frequency questionnaire), validated to mother and child respectively
Measured: 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)
Measured: 2 years data collection
Relative fitness level
Estimated relative fitness level assessed by a submaximal step test (The Danish Step Test)
Measured: 2 years data collection
Epigenetic examinations
Epigenetic examinations
Measured: 2 years data collection
Liver stiffness
FibroScan
Measured: 2 years data collection
Lung function
Spirometry assessing FVC and FEV1
Measured: 2 years data collection
Large artery stiffness
SphygmoCor examination
Measured: 2 years data collection
Eye examination
OPTOS
Measured: 2 years data collection
Sex hormones
Analyses of blood samples, children
Measured: 2 years data collection
Puberty stage
According to the classifications of Marshall and Tanner
Measured: 2 years data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start5 Jan 2023
- Primary completion26 Sep 2025
- Study completion26 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 497 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Statens Serum Institut, Lund University, University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Kristina M Renault, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446220
- Sponsor's protocol ID
- TOP12
- Acronym
- TOP12
- Status last verified
- Aug 2025
- First submitted
- 1 Jul 2022
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twelve-year Follow-up on the Treatment of Obese Pregnant Women (TOP) Study
- ClinicalTrials.gov ID
- NCT05446220
- Acronym / sponsor ID
- TOP12 / TOP12
- Conditions
- Obesity, Lifestyle, Healthy, Diet, Healthy, Follow-up, Physical Activity, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Statens Serum Institut, Lund University, University of Copenhagen
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Follow-up study on healthy lifestyle intervention during pregnancy (randomized controlled trial - TOP study) 12 years after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Diet + physical activity | Experimental | Behavioral: Lifestyle interventionDietary advise and advise on physical activity monitored by pedometer |
| Physical activity | Experimental | Behavioral: Lifestyle interventionAdvise on physical activity monitored by pedometer |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- There are no exclusion criteria as the potential study population has already been selected at the baseline study in 2009-2012
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle interventionDietary advise and/or advise on physical activity monitored by pedometer | Behavioural | Diet + physical activity, Physical activity |
Primary outcome
Body composition
Time frame: 2 years data collection
Fatt mass index offspring, DXA scan + BMI mothers
14 secondary outcomes
Metabolic and inflammatory markers
Time frame: 2 years data collection
Blood pressure
Time frame: 2 years data collection
Glycemic variability
Time frame: 2 years data collection
Mental health
Time frame: 2 years data collection
Diet composition
Time frame: 2 years data collection
Level and pattern of physical activity
Time frame: 2 years data collection
Relative fitness level
Time frame: 2 years data collection
Epigenetic examinations
Time frame: 2 years data collection
Liver stiffness
Time frame: 2 years data collection
Lung function
Time frame: 2 years data collection
Large artery stiffness
Time frame: 2 years data collection
Eye examination
Time frame: 2 years data collection
Sex hormones
Time frame: 2 years data collection
Puberty stage
Time frame: 2 years data collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina M Renault principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Obesity and Lifestyle, Healthy, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: 2 years data collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.