Clinical trial NCT04242069: Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Pregnancy Complications
Health Behavior
Life Style
Preconception Care
Keywords: Metabolomics
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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%.

Eligibility 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

Primary outcomes:
measure: Women's diet quality in preconception measured with the Canadian-Healthy Eating Index- 2007
timeFrame: 0, 2, 4, and 6 months
Secondary outcomes:
measure: Women's Urinary Food exposure Biomarker Profile
timeFrame: 0 and 2 months in preconception, 24- 26 weeks in pregnancy.
measure: Men and Women's diet quality measured with the Canadian-Healthy Eating Index- 2007.
timeFrame: 0, 2, 4, and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.
measure: Men and Women's physical activity level measured with the International Physical Activity Questionnaires Short Version.
timeFrame: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.
measure: Men and Women's steps per day measured with a Fitbit.
timeFrame: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.
measure: Men and Women's minutes of moderate and vigorous physical activity measured with a Fitbit.
timeFrame: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.
measure: Men and Women's Sleep quality measured with the Pittsburgh Sleep Quality Index
timeFrame: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.
measure: Men and Women's quality of life measured with the SF-12 v2
timeFrame: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.
measure: Men and Women's Anxiety and Depression symptoms measured with the Hospital Anxiety and Depression Scale.
timeFrame: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.
measure: Women's body fat percentage.
timeFrame: 0, 3, and 6 months in preconception.
measure: Women's waist circumference in centimeters.
timeFrame: 0, 3, and 6 months in preconception.
measure: Men and Women's weight in kilograms.
timeFrame: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.
measure: Men's body fat percentage.
timeFrame: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.
measure: Men's waist circumference in centimeters.
timeFrame: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.
measure: Proportion of adequate gestational weight gain
timeFrame: At delivery.
measure: Rate of pregnancy complications
timeFrame: At delivery.
Other outcomes:
measure: Fertility outcomes
timeFrame: After 9 months of follow-up.
Locations:
city: Québec
country: Canada
facility: Centre de recherche du CHU de Québec Université Laval
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre de recherche du CHUS
state: Quebec
Study officials:
affiliation: Researcher, Centre de recherche du CHUS
name: William D Fraser, MD,MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: Marchi J, Berg M, Dencker A, Olander EK, Begley C. Risks associated with obesity in pregnancy, for the mother and baby: a systematic review of reviews. Obes Rev. 2015 Aug;16(8):621-38. doi: 10.1111/obr.12288. Epub 2015 May 28.
citation: Battista MC, Hivert MF, Duval K, Baillargeon JP. Intergenerational cycle of obesity and diabetes: how can we reduce the burdens of these conditions on the health of future generations? Exp Diabetes Res. 2011;2011:596060. doi: 10.1155/2011/596060. Epub 2011 Oct 29.
citation: International Weight Management in Pregnancy (i-WIP) Collaborative Group. Effect of diet and physical activity based interventions in pregnancy on gestational weight gain and pregnancy outcomes: meta-analysis of individual participant data from randomised trials. BMJ. 2017 Jul 19;358:j3119. doi: 10.1136/bmj.j3119.
citation: Institute of Medicine (US) and National Research Council (US) Committee to Reexamine IOM Pregnancy Weight Guidelines; Rasmussen KM, Yaktine AL, editors. Weight Gain During Pregnancy: Reexamining the Guidelines. Washington (DC): National Academies Press (US); 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK32813/
citation: Garriguet D. Diet quality in Canada. Health Rep. 2009 Sep;20(3):41-52.
citation: Hardy I, Lloyd A, Morisset AS, Camirand Lemyre F, Baillargeon JP, Fraser WD. Healthy for My Baby Research Protocol- a Randomized Controlled Trial Assessing a Preconception Intervention to Improve the Lifestyle of Overweight Women and Their Partners. Front Public Health. 2021 Aug 3;9:670304. doi: 10.3389/fpubh.2021.670304. eCollection 2021.