Follow-up of Children Born From a Randomized Controlled Trial Assessing a Preconception Lifestyle Intervention in Women With Obesity and Infertility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Anthropometrics - BMI z score (child)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.).
研究组 & 干预措施
Intervention
Children born from mothers who were allocated to the intervention group in the Obesity-Fertility study.
干预措施: Fit-for-Fertility program (Behavioral)
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.
结局指标
主要结局
Anthropometrics - BMI z score (child)
时间窗: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
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)
次要结局
- Anthropometrics - Waist circumference(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.)
- 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.)
- 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.)
- Lifestyle - Number of steps per day measured by Fitbit (child)(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.)
- Lifestyle - Minutes per day of physical activity measured by Fitbit (child)(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.)
- 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 - Dietary behaviours by CTFEQr17 (child)(Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.)
- Lifestyle - Food intake (child)(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.)
- Lifestyle - Eating habits (mother)(Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.)
- Physical fitness level - Cardiorespiratory fitness (child)(Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.)
- Cardiometabolic health - Systolic and diastolic blood pressure(Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.)
- Physical fitness level - Grip strength (child)(Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.)
- Cardiometabolic health - Heart rate(Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.)
- Physical fitness level - Functional capacity (mother)(Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.)
- Cardiometabolic health - Total cholesterol (TC)(Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.)
- Cardiometabolic health - High-density lipoprotein (HDL) cholesterol(Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.)
- Cardiometabolic health - Low-density lipoprotein (LDL) cholesterol(Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.)
- Cardiometabolic health - Cholesterol ratio(Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.)
- Cardiometabolic health - Systolic and diastolic blood pressure Z-scores (child)(Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.)
- Cardiometabolic health - Triglycerides(Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.)
研究者
Jean-Patrice Baillargeon
Associate Professor
Université de Sherbrooke