Long-term follow-up on lifestyle interventions for obese pregnant women
Twelve-year Follow-up on the Treatment of Obese Pregnant Women (TOP) Study
This study is checking how lifestyle changes made during pregnancy affect the health of both mothers and their children 12 years later, focusing on preventing obesity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 12 Years to 60 Years |
| Sex | All |
| Sponsor | Steno Diabetes Center Copenhagen Academic / other |
| Locations | 1 site (Herlev) |
| Trial ID | NCT05446220 on ClinicalTrials.gov |
What this trial studies
This follow-up study invites participants from the original TOP study, which focused on obese pregnant women, to assess the long-term effects of lifestyle interventions on both mothers and their children 12 years after the initial intervention. The original study involved a randomized trial comparing a Mediterranean-style diet and physical activity to other interventions. The follow-up will include a 3-hour examination to evaluate the impact of these interventions on obesity transfer between generations. The study aims to enhance understanding of obesity prevention and treatment strategies.
Who should consider this trial
Good fit: Ideal candidates are mothers who participated in the initial TOP study and their children born during that time.
Not a fit: Patients who did not participate in the initial TOP study will not benefit from this follow-up.
Why it matters
Potential benefit: If successful, this study could provide insights into effective obesity prevention strategies for future generations.
How similar studies have performed: Similar studies have shown promising results in understanding the long-term effects of lifestyle interventions during pregnancy, making this follow-up both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Herlev
- Steno Diabetes Center Copenhagen — Herlev, Denmark (Recruiting)
Study contacts
- Principal investigator: Kristina M Renault — Rigshospitalet, Denmark
- Study coordinator: Kristina M Renault
- Email: kristina.martha.renault@regionh.dk
- Phone: 20250677
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.