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

Study Overview
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Brief Summary
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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.

Detailed Description
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In Canada, overweight and obesity are major public health concerns that affect nearly 45% of reproductive-age women. In pregnancy, overweight and excessive gestational weight gain are important risk factors for complications including gestational diabetes, hypertensive disorders of pregnancy, fetal macrosomia, and cesarean delivery. Women who are overweight in pregnancy and who gain excessive weight are also predisposed to subsequent obesity, and their offspring are predisposed to childhood obesity and metabolic syndrome. In light of the failure of pregnancy lifestyle interventions to improve pregnancy outcomes for overweight and obese women, earlier intervention is mandated. Preconception appears as a key period to prevent overweight and pregnancy complications. The main objective of this study is to evaluate the impact of the Healthy for my Baby intervention on the diet quality of women in the preconception period, as measured with the Canadian Healthy Eating Index 2007 (C-HEI). Urinary profiling of dietary exposure biomarkers will be used as a secondary assessment of diet quality. Secondary outcomes for preconception include the effect of the intervention on the lifestyle habits and anthropometric measures of women and their partners. In pregnancy, the main secondary objective is to evaluate the impact of the intervention on the pattern of gestational weight gain as defined by the 2009 Institute of Medicine recommendations. Other outcomes for pregnancy include the rates of gestational diabetes, hypertensive disorders of pregnancy, macrosomia, and cesarean delivery. The lifestyle habits of women and their partner and the anthropometric measures of their spouses will also be evaluated in pregnancy. Fertility outcomes will be reported as exploratory measures. Eligible subjects are couples aged 18 to 40 years who wish to conceive within 12 months of trial inclusion, in which the female partner has a BMI ≥ 25 kg/m2. Exclusion criteria are insufficient knowledge of French or English, an anticipated move to another region, a personal history of infertility, type 1 or 2 diabetes mellitus, prior bariatric surgery, an eating disorder established by clinical diagnosis, medical contraindication to pregnancy, medical contraindication to physical activity, participation in another intensive lifestyle intervention, or a 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. Couples will be randomized in blocks to the intervention or control group in a 1:1 ratio with randomly selected block size. The intervention will include two sessions of motivational interviewing on healthy lifestyle in preconception, and two more sessions in pregnancy. As an adjunct to in-person meetings, couples will have access to a mobile phone application to self-monitor daily lifestyle smart goals. Participants in the control group will receive standard advice on lifestyle as provided by their usual care provider. 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. Research visits will take place at study inclusion and every 3 months in preconception for up to 6 months. In pregnancy, study visits will take place in the first (6-8 weeks), second (24-26 weeks), and third (32-34 weeks) trimesters. The C-HEI will be measured at 0, 2, 4, and 6 months in preconception and every trimester in pregnancy with two web-based 24-hour dietary recalls. Urine samples will be collected at 0 and 2 months in preconception and at 24-26 weeks in pregnancy. Data on pregnancy and neonatal outcomes will be collected from medical files at the end of the trial. A sample size of 54 women is required to detect a 10-point difference in the C-HEI score (maximal value 100) between the groups with an alpha value of 5%, 80% power, and a 13 points standard deviation. Sixty-eight women and their partners will be recruited to account for a 20% attrition rate. The evolution of the C-HEI score with time in the preconception period will be compared between groups using a mixed linear model. Student's t-test will also be used to compare the average HEI-score between groups at 3, and 6-month follow-up. A statistical significance of 5% with Bonferroni correction for multiple comparisons will be used for the preconception primary outcome assessment. The concentration of 40 urinary metabolites will be compared between baseline, 2 months in preconception and 24-26 weeks of pregnancy using repeated measures ANOVA or Friedman test with a Bonferroni adjustment for multiple comparisons. The proportion of adequate gestational weight gain will be compared between groups with a Chi-squared test. Secondary outcomes will be assessed using Student's t-test, Wilcoxon test, Chi-squared test, or Fisher's exact test as appropriate. For all secondary outcomes statistical significance is set at 5%.

Official Title
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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

Conditions
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Overweight and Obesity, Pregnancy Complications, Health Behavior, Life Style, Preconception Care

Intervention / Treatment
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* Behavioral: Healthy for my Baby
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Healthy for my Baby Intervention | Behavioral: Healthy for my Baby<br>* 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.<br>|
| Other: Control<br>Usual care | Other: Usual Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0, 2, 4, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0 and 2 months in preconception, 24- 26 weeks in pregnancy. | 
| 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. | 0, 2, 4, and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy. | 
| 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. | 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy. | 
| 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. | 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy. | 
| Men and Women's minutes of moderate and vigorous physical activity measured with a Fitbit. | 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. | 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy. | 
| Men and Women's Sleep quality measured with the Pittsburgh Sleep Quality Index | Sleep quality measured with a questionnaire. Value range 0-21 with a higher score indicating lower sleep quality. | 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy. | 
| Men and Women's quality of life measured with the SF-12 v2 | 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. | 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy. | 
| Men and Women's Anxiety and Depression symptoms measured with the Hospital Anxiety and Depression Scale. | Anxiety and Depression symptoms measured with a questionnaire. Value range 0-42 with a higher score indicating more anxiety and depression symptoms. | 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy. | 
| Women's body fat percentage. | The change in body fat will be assessed in preconception using foot-to-foot bioimpedance. | 0, 3, and 6 months in preconception. | 
| Women's waist circumference in centimeters. | The change in waist circumference will be assessed in preconception using a measuring tape and a standardized protocol. | 0, 3, and 6 months in preconception. | 
| Men and Women's weight in kilograms. | The change in bodyweight will be assessed throughout the study using a calibrated scale. | 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy. | 
| Men's body fat percentage. | The change in body fat will be assessed throughout the study using foot-to-foot bioimpedance. | 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy. | 
| Men's waist circumference in centimeters. | The change in waist circumference will be assessed throughout the study using a measuring tape and a standardized protocol. | 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy. | 
| Proportion of adequate gestational weight gain | 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. | At delivery. | 
| Rate of pregnancy complications | 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. | At delivery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolomics