Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversité de Sherbrooke
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Insufficient knowledge of French or English
Anticipated move to another region
Personal history of infertility
Type 1 or 2 diabetes mellitus
Trial design
Design model
Parallel
Treatments tested in this trial
Healthy for my Baby
BehavioralParticipants 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 interventionParticipants 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.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlOther 1 intervention
Trial outcomes
Primary outcomes
1
Women's diet quality in preconception measured with the Canadian-Healthy Eating Index- 2007
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.
Time frame
0, 2, 4, and 6 monthsSecondary outcomes
1
Women's Urinary Food exposure Biomarker Profile
Three urine spot samples collected over a week will be pooled after normalizing using refractive index measurement to guide dilution. Around 40 metabolites will be targeted for the quantitative measurement of dietary intake biomarker concentrations.
Time frame
0 and 2 months in preconception, 24- 26 weeks in pregnancy.2
Men and Women's diet quality measured with the Canadian-Healthy Eating Index- 2007.
The C-HEI score will be measured with two or three online 24 hour dietary recalls at each time point (R24W tool). Value range 0-100 with a higher score indicating better diet quality.
Time frame
0, 2, 4, and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.3
Men and Women's physical activity level measured with the International Physical Activity Questionnaires Short Version.
Physical activity measured in MET-minutes/week. Value range of 0-5000 MET-minutes/week with a higher score indicating a higher activity level.
Time frame
0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.4
Men and Women's steps per day measured with a Fitbit.
Steps per day measured with a wristband accelerometer over 7 days . Value range 0- 15 000 steps per day with a higher step count indicating a higher activity level.
Time frame
0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.Other outcomes
1
Fertility outcomes
Rates of clinical pregnancies (embryo with a positive heartbeat on first trimester ultrasound), spontaneous miscarriage (unviable pregnancy prior to 20 weeks of gestation), and live birth rate.
Time frame
After 9 months of follow-up.Sponsors and contacts
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Source ClinicalTrials.gov