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

NCT04242069 | Recruiting DMC

• 1 other identifier: 2020-3291
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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.

Conditions

Overweight and Obesity; Pregnancy Complications; Health Behavior; Life Style; Preconception Care

Keywords

Metabolomics

Outcome Measures

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.

  0, 2, 4, and 6 months

Secondary Outcomes (15)

• Women's Urinary Food exposure Biomarker Profile

  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.

  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.

  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.

  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.

  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

  After 9 months of follow-up.

Study Arms (2)

Intervention

EXPERIMENTAL

Healthy for my Baby Intervention

Behavioral: Healthy for my Baby

Control

OTHER

Usual care

Other: Usual Care

Interventions

Healthy for my Baby BEHAVIORAL

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.

Intervention

Usual Care OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Woman's body mass index ≥ 25 kg/m2
• Access to a smart phone

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (2)

Centre de recherche du CHU de Québec Université Laval

Québec, Quebec, G1V 4G2, Canada

RECRUITING

Centre de recherche du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Related Publications (7)

• 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

  BACKGROUND

• 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.

  PMID: 26016557 BACKGROUND

• 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.

  PMID: 22110473 BACKGROUND

• 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.

  PMID: 28724518 BACKGROUND

• 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/

  PMID: 20669500 BACKGROUND

• Garriguet D. Diet quality in Canada. Health Rep. 2009 Sep;20(3):41-52.

  PMID: 19813438 BACKGROUND

• 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.

  PMID: 34414154 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Pregnancy Complications; Health Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior

Study Officials

• William D Fraser, MD,MSc

  Researcher, Centre de recherche du CHUS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana C Colmenares, MD

CONTACT

1-819-674-3780; ensantepourbebe@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 27, 2020
• Study Start: June 18, 2021
• Primary Completion: December 30, 2025
• Study Completion (Estimated): July 30, 2026
• Last Updated: April 2, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)