Risks associated with obesity in pregnancy, for the mother and baby: a systematic review of reviews.
J Marchi, M Berg, A Dencker...
https://pubmed.ncbi.nlm.nih.gov/26016557Actively Recruiting
Phase Not Applicable
Age: 18Years - 40Years
All Genders
Healthy Volunteers
ID04242069
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
Led by Université de Sherbrooke · Updated on 2025-04-02
68
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a combined approach of motivational interviewing and a mobile phone application can help overweight women and their partners adopt healthier lifestyle habits before pregnancy. This study also looks at how the intervention affects women's and their partners' weight, waist size, and body fat. During pregnancy, the study will explore the impact on appropriate weight gain, pregnancy complications, delivery methods, and the baby's birth weight. Participants are divided into two groups: one receives the "Healthy for my Baby" intervention, which includes motivational interviews and a mobile app to track lifestyle goals, while the other group receives usual care with standard lifestyle advice and access to a simplified app for fertility and visit tracking. The intervention includes two interviews before conception and two more during pregnancy, with lifestyle goals adjusted as needed. Participants will attend study visits at enrollment and every three months before pregnancy, then during each trimester. Researchers will assess diet quality through dietary recalls and urine samples, monitor physical activity with questionnaires and Fitbit devices, and track body measurements like weight, waist circumference, and body fat. Pregnancy and newborn health data will be collected from medical records. The main measurement is the women's diet quality score during preconception.
CONDITIONS
Brief Title
Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
Who Can Participate
Age: 18Years - 40Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Women and their partner who wish to conceive within 12 months of trial inclusion
- Woman's body mass index 825 kg/m2
- Access to a smart phone
- Age between 18 and 40 years
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Preconception Period
Duration - Up to 6 months
Participants will engage in lifestyle interventions including motivational interviews and use of a mobile application to track daily lifestyle goals aimed at improving diet quality and physical activity before pregnancy.
Research visits at study inclusion and every 3 months for up to 6 months
Pregnancy Period
Duration - From pregnancy confirmation through third trimester
Participants who become pregnant will continue lifestyle interventions with additional motivational interviews and adapted goals via the mobile application throughout pregnancy.
Study visits in the first (6-8 weeks), second (24-26 weeks), and third (32-34 weeks) trimesters
Pregnancy Outcome Monitoring
Duration - Until delivery
Pregnancy and neonatal outcomes will be collected from medical records after delivery to assess the impact of the intervention on gestational weight gain and pregnancy complications.
No additional visits; data collected from medical files
Trial Site Locations
Total: 2 locations
1
Centre de recherche du CHU de Québec Université Laval
Québec, Quebec, Canada, G1V 4G2
Actively Recruiting
2
Centre de recherche du CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
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Research Team
A
Ana C Colmenares, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Intergenerational cycle of obesity and diabetes: how can we reduce the burdens of these conditions on the health of future generations?
Marie-Claude Battista, Marie-France Hivert, Karine Duval...
https://pubmed.ncbi.nlm.nih.gov/22110473Effect of diet and physical activity based interventions in pregnancy on gestational weight gain and pregnancy outcomes: meta-analysis of individual participant data from randomised trials.
International Weight Management in Pregnancy (i-WIP) Collaborative Group
https://pubmed.ncbi.nlm.nih.gov/28724518Diet quality in Canada.
Didier Garriguet
https://pubmed.ncbi.nlm.nih.gov/19813438Healthy for My Baby Research Protocol- a Randomized Controlled Trial Assessing a Preconception Intervention to Improve the Lifestyle of Overweight Women and Their Partners.
Isabelle Hardy, Amanda Lloyd, Anne-Sophie Morisset...
https://pubmed.ncbi.nlm.nih.gov/34414154