Clinical trial

Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception

Recruiting now · Not applicable · 1 countries · Registry ID NCT04242069

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 40 Years

SexAll

Healthy volunteersAccepted

ConditionOverweight and Obesity, Pregnancy Complications, Health Behavior, Life Style, Preconception Care

Full registry 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

Treatments and study arms

Healthy for my Baby

Behavioral

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.

Usual Care

Other

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.

Primary outcomes

Women's diet quality in preconception measured with the Canadian-Healthy Eating Index- 20070, 2, 4, and 6 months

Women's C-HEI score will be measured with two or three online 24 hour dietary recalls (R24W tool) at each time point. Value range 0-100 with a higher score indicating better diet quality. The change of the score in time during the preconception period will be compared between the groups.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Centre de recherche du CHU de Québec Université Laval🇨🇦 Québec, Quebec, Canada

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Anne-Sophie Plante, MScContact

Call 418 525-4444

Centre de recherche du CHUS🇨🇦 Sherbrooke, Quebec, Canada

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Ana C Colmenares, MDContact

Email · Call 819-674-3780