NCT04242069 Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
| NCT ID | NCT04242069 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Université de Sherbrooke |
| Condition | Overweight and Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2021-06-18 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2021-06-18 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to determine whether an intervention combining motivational interviewing and follow-up with a mobile phone application will help overweight women and their partners adopt healthy lifestyle habits in the preconception period. This study will also evaluate the impact of the intervention on the weight, waist circumference, and body fat of women and their partners. Women and their partners will be followed through pregnancy to explore the effects of the intervention on the adequacy of gestational weight gain, rates of pregnancy complications, delivery mode, and infant birth weight.
Eligibility 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
Contact & Investigator
William D Fraser, MD,MSc
PRINCIPAL INVESTIGATOR
Researcher, Centre de recherche du CHUS
Frequently Asked Questions
Who can join the NCT04242069 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Overweight and Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04242069 currently recruiting?
Yes, NCT04242069 is actively recruiting participants. Contact the research team at ensantepourbebe@usherbrooke.ca for enrollment information.
Where is the NCT04242069 trial being conducted?
This trial is being conducted at Québec, Canada, Sherbrooke, Canada.
Who is sponsoring the NCT04242069 clinical trial?
NCT04242069 is sponsored by Université de Sherbrooke. The principal investigator is William D Fraser, MD,MSc at Researcher, Centre de recherche du CHUS. The trial plans to enroll 68 participants.
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