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

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ClinicalTrials.gov Identifier: NCT04242069
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Université de Sherbrooke

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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Pregnancy Complications Health Behavior Life Style Preconception Care Behavioral: Healthy for my Baby Other: Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : April 30, 2022

Arm Intervention/treatment
Experimental: Intervention
Healthy for my Baby Intervention
Behavioral: Healthy for my Baby

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.


Control
Usual care
Other: Usual Care

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 Outcome Measures :
  1. Women's diet quality in preconception measured with the Canadian-Healthy Eating Index- 2007 [ Time Frame: 0, 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.


Secondary Outcome Measures :
  1. Men and Women's physical activity level measured with the International Physical Activity Questionnaires Short Version. [ Time Frame: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy. ]
    Physical activity measured in MET-minutes/week. Value range of 0-5000 MET-minutes/week with a higher score indicating a higher activity level.

  2. Men and Women's steps per day measured with a Fitbit. [ Time Frame: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy. ]
    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.

  3. Men and Women's minutes of moderate and vigorous physical activity measured with a Fitbit. [ Time Frame: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy. ]
    Minutes of moderate and vigorous physical activity per week measured with a wristband accelerometer over 7 days. Value range 0-800 minutes with a higher number of minutes indicating a higher activity level.

  4. Men and Women's Sleep quality measured with the Pittsburgh Sleep Quality Index [ Time Frame: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy. ]
    Sleep quality measured with a questionnaire. Value range 0-21 with a higher score indicating lower sleep quality.

  5. Men and Women's quality of life measured with the SF-12 v2 [ Time Frame: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy. ]
    Quality of life measured with a questionnaire and reported as a t-score. Value range 0-100 with a higher score indicating better quality of life.

  6. Men and Women's Anxiety and Depression symptoms measured with the Hospital Anxiety and Depression Scale. [ Time Frame: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy. ]
    Anxiety and Depression symptoms measured with a questionnaire. Value range 0-42 with a higher score indicating more anxiety and depression symptoms.

  7. Women's body fat percentage. [ Time Frame: 0, 3, and 6 months in preconception. ]
    The change in body fat will be assessed in preconception using foot-to-foot bioimpedance.

  8. Women's waist circumference in centimeters. [ Time Frame: 0, 3, and 6 months in preconception. ]
    The change in waist circumference will be assessed in preconception using a measuring tape and a standardized protocol.

  9. Men and Women's weight in kilograms. [ Time Frame: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy. ]
    The change in bodyweight will be assessed throughout the study using a calibrated scale.

  10. Men's body fat percentage. [ Time Frame: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy. ]
    The change in body fat will be assessed throughout the study using foot-to-foot bioimpedance.

  11. Men's waist circumference in centimeters. [ Time Frame: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy. ]
    The change in waist circumference will be assessed throughout the study using a measuring tape and a standardized protocol.

  12. Women's diet quality in pregnancy measured with the Canadian-Healthy Eating Index- 2007. [ Time Frame: 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy. ]
    Women's 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.

  13. Proportion of adequate gestational weight gain [ Time Frame: At delivery. ]
    Women's total weight gain in pregnancy will be obtained from their medical file. The proportion of adequate gestational weight gain according to BMI specific recommendations (IOM, 2009) will be compared between groups.

  14. Rate of pregnancy complications [ Time Frame: At delivery. ]
    Rates of gestational diabetes (diagnosed with a provoked hyperglycemia test or serial capillary glycemia measures), gestational hypertension (clinical diagnosis), pre-eclampsia (clinical diagnosis), fetal macrosomia (birth weight over the 90th percentile for the gestational age and sex), and mode of delivery.


Other Outcome Measures:
  1. Fertility outcomes [ Time Frame: After 9 months of follow-up. ]
    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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women and their partners who wish to conceive within 6 months of trial inclusion
  • Both members of the couple agree to take part in the study
  • 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
Publications:
Government of Canada SC. Measured adult body mass index (BMI) (World Health Organization classification), by age group and sex, Canada and provinces, Canadian Community Health Survey - Nutrition [Internet]. 2017. Available at: https://www150.statcan.gc.ca/t1/tbl1/en/tv.action?pid=1310079401
Institute of Medicine (US) and National Research Council (US) Committee to Reexamine IOM Pregnancy Weight Guidelines. Weight Gain During Pregnancy: Reexamining the Guidelines [Internet]. Rasmussen KM, Yaktine AL, éditeurs. Washington (DC): National Academies Press (US); 2009

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Responsible Party: Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT04242069    
Other Study ID Numbers: 2020-3291
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pregnancy Complications
Overweight
Body Weight
Signs and Symptoms