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

NCT06402825 | Completed

• 1 other identifier: 2024-5150
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Obesity; Maternal obesity; Healthy lifestyle; Preconception care; Fetal programming

Outcome Measures

Primary Outcomes (1)

• Anthropometrics - BMI z score (child)

  BMI Z-score adjusted for age and sex calculated according to World Health Organization reference values (AnthroPlus software, version 1.0, last updated September 17, 2014)

  Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.

Secondary Outcomes (21)

• Anthropometrics - Waist circumference

  Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.

• Anthropometrics - Waist-to-height ratio (child)

  Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.

• Body composition measured by dual-energy X-ray absorptiometry

  Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.

• Lifestyle - Self-reported physical activity by GSLTPAQ (child)

  Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.

• Lifestyle - Self-reported physical activity level (mother)

  Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.

Study Arms (2)

Intervention

Children born from mothers who were allocated to the intervention group in the Obesity-Fertility study.

Behavioral: Fit-for-Fertility program

Control

Children born from mothers who were allocated to the control group in the Obesity-Fertility study. Participants in the control group received standard care from the fertility clinic without delay.

Interventions

Fit-for-Fertility program BEHAVIORAL

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).

Intervention

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children born from mothers who participated in the Obesity-Fertility study. Those mother were recruited between 2012 and 2018 at the fertility clinic of the Centre hospitalier universitaire de Sherbrooke. To be included in the study, they had to be aged between 18 and 40 years and living with infertility and obesity, or overweight if they had polycystic ovary syndrome (PCOS). Women were excluded if they had undergone or were planning bariatric surgery, or if natural conception was impossible or unlikely (such as both fallopian tubes blocked or severe male factor).

You may qualify if:

• Offsprings of women who were randomized in the Obesity-Fertility study known to have been conceived within 18 months following randomization of their mothers from a singleton pregnancy.

You may not qualify if:

• Children having a disease or taking a medication that has a major impact on weight, anthropometry, lifestyle habits or functional capacity (e.g., congenital heart disease, functional disability, severe asthma, regular use of glucocorticoids, etc.).

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (2)

• Duval K, Langlois MF, Carranza-Mamane B, Pesant MH, Hivert MF, Poder TG, Lavoie HB, Ainmelk Y, St-Cyr Tribble D, Laredo S, Greenblatt E, Sagle M, Waddell G, Belisle S, Riverin D, Jean-Denis F, Belan M, Baillargeon JP. The Obesity-Fertility Protocol: a randomized controlled trial assessing clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women. BMC Obes. 2015 Dec 1;2:47. doi: 10.1186/s40608-015-0077-x. eCollection 2015.

  PMID: 26635965 BACKGROUND

• Thibodeau A, Jean-Denis F, Harnois-Leblanc S, Perron P, Mathieu ME, Dallaire F, Morisset AS, Brochu M, Baillargeon JP. Obesity-fertility cohort study: protocol for the assessment of children aged 6-12 years and their mothers. BMJ Open. 2025 Apr 17;15(4):e091140. doi: 10.1136/bmjopen-2024-091140.

  PMID: 40246570 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, saliva

MeSH Terms

Conditions

Pediatric Obesity; Obesity; Pregnancy in Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Jean-Patrice Baillargeon, MD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 7, 2024
• Study Start: November 13, 2023
• Primary Completion: February 21, 2025
• Study Completion: June 23, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

CA (1)