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Obesity-fertility Cohort Study: Protocol for the Assessment of Children Aged 6-12 Years and Their Mothers

NCT06402825 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2026-05-06

No results posted yet for this study

Summary

Maternal preconception obesity and adverse gestational metabolic health increase the risk of childhood obesity in offspring. A group of investigators from Université de Sherbrooke therefore developed a lifestyle intervention starting during preconception in women with obesity and infertility, which was evaluated with the Obesity-Fertility randomized controlled trial (RCT). The present study will assess children who were born in the Obesity-Fertility RCT and are now aged 6-10 years old. The objective of this study is to evaluate the effect of a lifestyle intervention during preconception and pregnancy on adiposity and cardiometabolic parameters in offspring compared to those born to mothers who did not have access to the lifestyle intervention. The hypothesis being that, at the age of 6-10 years old, children born to mothers who were in the intervention group have more favorable measurements of body composition and certain metabolic and/or inflammatory blood markers than those born to control mothers.

Participants in the Obesity-Fertility RCT were women with obesity and infertility recruited at the Centre hospitalier universitaire de Sherbrooke (CHUS) fertility clinic. They were randomly allocated to the control group, which followed standard care, or to the intervention group, which received a lifestyle intervention alone for 6 months, and then in combination with fertility treatments. Those who have given birth to a single child will be invited to participate in this follow-up study with their child. During the research visit, medical history, anthropometry, body composition, lifestyle, physical fitness level, and blood or saliva markers of cardiometabolic health will be assessed for both mothers and children.

This study will provide new evidence on the impact of targeting lifestyle habits during preconception on the health of children and their mothers 6-10 years later; and the potential of such interventions to counteract the intergenerational transmission of obesity.

Conditions

  • Obesity, Childhood
  • Lifestyle Intervention
  • Preconception Care

Interventions

BEHAVIORAL

Fit-for-Fertility program

Women in the intervention group had to delay fertility treatments for 6 months and were offered the interdisciplinary lifestyle intervention, which was provided for a maximum of 18 months or until the end of a pregnancy that occurred. The lifestyle intervention consisted of individual meetings with a dietitian and a kinesiologist trained in motivational interviewing, combined with 12 educational group sessions during the first 6 months. Details of the lifestyle intervention are presented in the previously published protocol (Duval et al., 2015).

Sponsors & Collaborators

  • Université de Sherbrooke

    lead OTHER

Principal Investigators

  • Jean-Patrice Baillargeon, MD · Université de Sherbrooke

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-13
Primary Completion
2025-02-21
Completion
2025-06-23

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06402825 on ClinicalTrials.gov