Overweight and Obesity Clinical Trial
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
NCT number | NCT04242069 |
Other study ID # | 2020-3291 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 18, 2021 |
Est. completion date | July 30, 2026 |
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.
Status | Recruiting |
Enrollment | 68 |
Est. completion date | July 30, 2026 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Centre de recherche du CHU de Québec Université Laval | Québec | |
Canada | Centre de recherche du CHUS | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke |
Canada,
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. — View Citation
Garriguet D. Diet quality in Canada. Health Rep. 2009 Sep;20(3):41-52. — View 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
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/ — View 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. Erratum In: BMJ. 2017 Aug 23;358:j3991. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | After 9 months of follow-up. | |
Primary | 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 | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. |
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