Lifestyle intervention for overweight women planning to conceive
Healthy for my Baby- A Randomized Controlled Trial Assessing a Preconception Clinically Integrated Technological Intervention to Improve the Lifestyle of Overweight Women and Their Partners
This study is testing a program that helps overweight women and their partners make healthier choices before getting pregnant to see if it can lead to better pregnancy outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Université de Sherbrooke Academic / other |
| Locations | 2 sites (Québec, Quebec and 1 other locations) |
| Trial ID | NCT04242069 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a lifestyle intervention that combines motivational interviewing and a mobile app to help overweight women and their partners adopt healthier habits before conception. It aims to improve diet quality and monitor changes in weight, waist circumference, and body fat. Participants will be followed through pregnancy to assess the intervention's impact on gestational weight gain, pregnancy complications, delivery methods, and infant birth weight. The study addresses the critical need for early intervention to prevent obesity-related complications in pregnancy.
Who should consider this trial
Good fit: Ideal candidates are overweight women with a BMI of 25 kg/m2 or higher who wish to conceive within the next 12 months, along with their partners.
Not a fit: Patients with a personal history of infertility, diabetes, or other medical contraindications to pregnancy or physical activity may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to healthier pregnancies and better outcomes for both mothers and infants.
How similar studies have performed: Other studies have shown promise in lifestyle interventions for overweight women, but this specific approach targeting the preconception period is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women and their partner who wish to conceive within 12 months of trial inclusion * Woman's body mass index ≥ 25 kg/m2 * Access to a smart phone Exclusion Criteria: * Insufficient knowledge of French or English * Anticipated move to another region * Personal history of infertility * Type 1 or 2 diabetes mellitus * Prior bariatric surgery * Active eating disorder established by clinical diagnosis * Medical contraindication to pregnancy * Medical contraindication to physical activity * Participation in another intensive lifestyle intervention * Known or anticipated disease or surgery likely to cause an important weight loss * Multiple pregnancies will be excluded from the pregnancy follow-up to limit aberrant data
Where this trial is running
Québec, Quebec and 1 other locations
- Centre de recherche du CHU de Québec Université Laval — Québec, Quebec, Canada (Recruiting)
- Centre de recherche du CHUS — Sherbrooke, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: William D Fraser, MD,MSc — Researcher, Centre de recherche du CHUS
- Study coordinator: Ana C Colmenares, MD
- Email: ensantepourbebe@usherbrooke.ca
- Phone: 1-819-674-3780
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.