Obesity, ChildhoodNCT06402825
Obesity-fertility Cohort Study: Protocol for the Assessment of Children Aged 6-12 Years and Their Mothers
An observational study of Obesity, Childhood and Lifestyle Intervention, run by Université de Sherbrooke at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Lifestyle Intervention, Preconception Care
- What is being tested?
- Fit-for-Fertility program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 13 Nov 2023to 23 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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).
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Follow-up of Children Born From a Randomized Controlled Trial Assessing a Preconception Lifestyle Intervention in Women With Obesity and Infertility
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.
Read the 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.
- Being tested
- Fit-for-Fertility program
- Keywords
- Obesity, Maternal obesity, Healthy lifestyle, Preconception care, Fetal programming
- Medical subject headings
- Pediatric Obesity, Obesity, Pregnancy in Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit-for-Fertility programBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Children born from mothers who were allocated to the intervention group in the Obesity-Fertility study. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured at the highest point of the iliac crests according to the National Institutes of Health (NIH) method to the nearest 0.1 cm with a flexible tape
Measured: 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)
Calculated from the child's waist circumference (cm) and height (cm).
Measured: 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
Fat and lean body mass, ratio
Measured: 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)
Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ) measures frequency and intensity of physical activity practiced by the child during the past seven days
Measured: 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)
Questionnaire adapted from the 2009 Canadian Community Health Survey of Statistics Canada
Measured: 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)
Fitbit wristband monitor worn for seven consecutive days
Measured: 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)
Fitbit wristband monitor worn for seven consecutive days
Measured: 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 - Dietary behaviours by CTFEQr17 (child)
French version of the Child Three-Factor Eating Questionnaire (CTFEQr17)
Measured: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
Lifestyle - Food intake (child)
Online 24-hour dietary recall survey developed by Laval University
Measured: 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)
Questionnaire adapted from the 2009 Canadian Community Health Survey of Statistics Canada
Measured: 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)
Maximal exertion test using the McMaster protocol
Measured: 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)
Hand dynamometer (kg)
Measured: 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)
Six-minute walk test
Measured: 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
Arm cuff appropriate for the arm size (mmHg)
Measured: 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)
Age-, sex- and height-adjusted Z-scores from normative tables from the American Academy of Pediatrics Pediatric Reference Guidelines
Measured: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
Cardiometabolic health - Heart rate
Arm cuff appropriate for the arm size (bpm)
Measured: 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)
Fasting levels
Measured: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
Cardiometabolic health - Triglycerides
Fasting levels
Measured: 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
Fasting levels
Measured: 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
Fasting levels
Measured: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
Cardiometabolic health - Cholesterol ratio
Fasting levels of TC divide by fasting levels of HDL
Measured: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start13 Nov 2023
- Primary completion21 Feb 2025
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Patrice Baillargeon, Université de Sherbrooke
- Investigators
- Jean-Patrice Baillargeon, MD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402825
- Sponsor's protocol ID
- 2024-5150
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2024
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26635965Thibodeau 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.
PubMed 40246570
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Children Born From a Randomized Controlled Trial Assessing a Preconception Lifestyle Intervention in Women With Obesity and Infertility
- ClinicalTrials.gov ID
- NCT06402825
- Acronym / sponsor ID
- 2024-5150
- Keywords
- Obesity, Maternal obesity, Healthy lifestyle, Preconception care, Fetal programming
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 21 Feb 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Behavioral: Fit-for-Fertility programChildren born from mothers who were allocated to the intervention group in the Obesity-Fertility study. |
| 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fit-for-Fertility programWomen 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). | Behavioural | Intervention |
Primary outcome
Anthropometrics - BMI z score (child)
Time frame: 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)
21 secondary outcomes
Anthropometrics - Waist circumference
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 - Dietary behaviours by CTFEQr17 (child)
Time frame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
Lifestyle - Food intake (child)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
Cardiometabolic health - Heart rate
Time frame: 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)
Time frame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
Cardiometabolic health - Triglycerides
Time frame: 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
Time frame: 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
Time frame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
Cardiometabolic health - Cholesterol ratio
Time frame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background: PubMed 26635965Duval 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.
- Derived from this study: PubMed 40246570Thibodeau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Patrice Baillargeon, MD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Childhood and Lifestyle Intervention, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometrics - BMI z score (child) (time frame: Once, between October 2023 and September 2024 (11 months), which is 6 to 10 years after the child's birth.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06402825, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.