Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
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
Université de Sherbrooke
68 participants
Jun 18, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria11
- 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
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Interventions
Participants will start the preconception intervention by meeting with a health professional for a motivational interview session on healthy lifestyle habits. Following this interview, participants will have access to a mobile phone application that will allow them to track daily lifestyle modification goals. After a month, they will meet the health professional for a second motivational interview and review their progression. Participants will continue to make lifestyle changes through the preconception period by accomplishing smart goals followed daily in the mobile phone application. If the woman becomes pregnant, the couple will participate in two more in-person motivational interviews, a month apart. The mobile application will be put in pregnancy mode, and participants will adapt their daily lifestyle goals for the pregnancy. Participants will continue to make lifestyle changes throughout pregnancy by accomplishing smart goals followed daily in the mobile phone application.
Participants in the control group will receive standard advice on healthy lifestyle habits as provided by their usual care provider. They will receive standard medical care in preconception and pregnancy. To improve compliance with the study follow-up, participants in this group will have access to a simplified version of the mobile application that contains a fertility calendar and a research visit calendar. This version of the application does not include lifestyle goals or any information on healthy lifestyle habits.
Locations(2)
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NCT04242069