Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402825
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-07
First Post:
2024-04-23
Brief Title:
Follow-up of Children Born From a Preconception Lifestyle Intervention in Women With Obesity and Infertility
Sponsor:
Université de Sherbrooke
Organization:
Université de Sherbrooke
Study Overview
Official Title:
Follow-up of Children Born From a Randomized Controlled Trial Assessing a Preconception Lifestyle Intervention in Women With Obesity and Infertility
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
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 ClinicalTrialsgov 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None