Recruiting

Lifestyle Intervention

Sponsor:

Université de Sherbrooke

Code:

NCT04242069

Conditions

Overweight and Obesity

Pregnancy Complications

Health Behavior

Life Style

Preconception Care

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Healthy for my Baby

Usual Care

Study Details

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

Study ID

NCT04242069

Start date

Jun 18, 2021

Status verified date

Dec, 2024

Completion date

Jul 30, 2026

Anticipated

Primary completion date

Dec 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention

Healthy for my Baby Intervention

other: Control

Usual care

Interventions

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.

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 measure

  • Women's diet quality in preconception measured with the Canadian-Healthy Eating Index- 2007 [ Time Frame: 0, 2, 4, and 6 months ]

Central Contacts and Locations

Central contacts

Ana C Colmenares, MD

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

Locations

Centre de recherche du CHU de Québec Université Laval

Recruiting

Québec, Quebec, Canada, G1V 4G2

Contacts

Anne-Sophie Plante, MSc

418 525-4444

Centre de recherche du CHUS

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Ana C Colmenares, MD

819-674-3780ensantepourbebe@usherbrooke.ca

More Information

Sponsor

Université de Sherbrooke

Last update posted

Apr 2, 2025

Last verified

Dec, 2024

Keywords

  • Metabolomics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2025-04-02.