Clinical trial NCT06402825: Obesity-fertility Cohort Study: Protocol for the Assessment of Children Aged 6-12 Years and Their Mothers
Official title: Follow-up of Children Born From a Randomized Controlled Trial Assessing a Preconception Lifestyle Intervention in Women With Obesity and Infertility
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Obesity, Childhood
Lifestyle Intervention
Preconception Care
Keywords: Obesity
Maternal obesity
Healthy lifestyle
Preconception care
Fetal programming
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 47
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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).

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.

Detailed description: INTRODUCTION: 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) registered at ClinicalTrials.gov (NCT01483612). 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.

METHODS AND ANALYSIS: Participants in the Obesity-Fertility RCT were women with obesity and infertility recruited at the CHUS fertility clinic between January 2012 and August 2018. 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. This study will take place from October 2023 to September 2024, when the child will be 6-10 years old. 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. Of the 130 women who participated in the Obesity-Fertility RCT, 53 mother-child dyads are potentially eligible for this follow-up study. Comparisons between groups will be performed using appropriate unpaired tests and adjusted for potential confounders using multiple regression models.

ETHICS AND DISSEMINATION: The study has been approved by the Institutional Research Ethics Review Boards of the CHUS. The results will be widely disseminated to the scientific community as well as to relevant health professionals and the general public.

IMPACT: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.).

Primary outcomes:
measure: Anthropometrics - BMI z score (child)
timeFrame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
Secondary outcomes:
measure: Anthropometrics - Waist circumference
timeFrame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
measure: Anthropometrics - Waist-to-height ratio (child)
timeFrame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
measure: Body composition measured by dual-energy X-ray absorptiometry
timeFrame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
measure: Lifestyle - Self-reported physical activity by GSLTPAQ (child)
timeFrame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
measure: Lifestyle - Self-reported physical activity level (mother)
timeFrame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
measure: Lifestyle - Number of steps per day measured by Fitbit (child)
timeFrame: Once, over a one-week period, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
measure: Lifestyle - Minutes per day of physical activity measured by Fitbit (child)
timeFrame: Once, over a one-week period, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
measure: Lifestyle - Dietary behaviours by CTFEQr17 (child)
timeFrame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
measure: Lifestyle - Food intake (child)
timeFrame: Three dietary recall, over a period of four weeks, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
measure: Lifestyle - Eating habits (mother)
timeFrame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
measure: Physical fitness level - Cardiorespiratory fitness (child)
timeFrame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
measure: Physical fitness level - Grip strength (child)
timeFrame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
measure: Physical fitness level - Functional capacity (mother)
timeFrame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
measure: Cardiometabolic health - Systolic and diastolic blood pressure
timeFrame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
measure: Cardiometabolic health - Systolic and diastolic blood pressure Z-scores (child)
timeFrame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
measure: Cardiometabolic health - Heart rate
timeFrame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
measure: Cardiometabolic health - Total cholesterol (TC)
timeFrame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
measure: Cardiometabolic health - Triglycerides
timeFrame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
measure: Cardiometabolic health - High-density lipoprotein (HDL) cholesterol
timeFrame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
measure: Cardiometabolic health - Low-density lipoprotein (LDL) cholesterol
timeFrame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
measure: Cardiometabolic health - Cholesterol ratio
timeFrame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Jean-Patrice Baillargeon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.