Childhood ObesityNCT01129505
Preventing Childhood Obesity: A Two-pronged Approach Starting in Pregnancy and the First Year Postpartum
A study testing Nutrition & Exercise Lifestyle Intervention Program (NELIP) in people with Childhood Obesity and Excessive Weight Gain in Pregnancy With Baby Delivered, run by Western University, Canada at 1 site in Canada.
Trial summary
Our longitudinal aim is to reduce childhood obesity using our two-pronged intervention program, which includes healthy food choices and increased physical activity initiated during pregnancy and re-instated in the early period after delivery for overweight and obese women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Excessive Weight Gain in Pregnancy With Baby Delivered, Dietary Modification
- What is being tested?
- Nutrition & Exercise Lifestyle Intervention Program (NELIP)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to Dec 2013
- Phase
- Interventional
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- medically pre-screened for contraindications to exercise
- prior to 16 weeks gestation (pregnancy program)
- singleton pregnancy and pre-pregnancy BMI equal or greater than 25
- before 2 months post delivery (postpartum program)
- BMI equal or greater than 25 (postpartum program)
Who cannot join
- diagnosed with gestational diabetes or type 2 diabetes
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario
London, Ontario, N6A 3K7
About this study
Official title: Preventing Childhood Obesity: Early Intervention During Pregnancy and First Year Postpartum for Overweight and Obese Women Using a Two-pronged Family-based Nutrition & Exercise Lifestyle Intervention Program (NELIP).
Our longitudinal aim is to reduce childhood obesity using our two-pronged intervention program, which includes healthy food choices and increased physical activity initiated during pregnancy and re-instated in the early period after delivery for overweight and obese women. We will accomplish this with our family-based Nutrition and Exercise Lifestyle Intervention Program (NELIP) to promote healthy family living. An intervention targeting school-aged children on the importance of healthy lifestyles occurs too late to prevent childhood obesity and establish lifelong healthy body weights. To break this spiraling cycle of generations of unhealthy body weights in Canadian children, and to reduce the risk of future obesity-related health problems, it is necessary to prevent excessive pregnancy weight gain, high blood sugars in the mother and to promote a healthy lifestyle during pregnancy and early post delivery. With our NELIP team as a cornerstone, and our pilot data already collected with promising results, we foresee an opportunity over the next 3 years to contribute to changing patient care with emphasis on disease prevention and healthy family lifestyle initiation early in life to reverse the trend of childhood obesity. With a solid research-based initiative from the lab to the community by educating health care providers, future health care can be improved by putting prevention-based programs into practice.
Healthy women = healthy babies = healthy families = healthy futures!!
Read the detailed description
Overweight and obesity have been identified as major neglected public health issues, as the prevalence of unhealthy body weights is increasing world-wide at an alarming rate. There is a robust link between the fetal environment and its long-term influence on health and susceptibility to future chronic disease in the offspring. Obesity begets obesity, and an unhealthy maternal metabolic state can have a profound influence on the risk of early obesity development in the child. Excessive pregnancy weight gain and high pre-pregnant body-mass index (BMI) have been linked to gestational diabetes (GDM) and macrosomic infants (birth weight >4.0kg. Since much of the influence of the intrauterine milieu is transmitted to the next generation non-genetically, potentially deleterious effects can be reversed and prevented. An intervention targeting school-aged children on the importance of healthy lifestyles occurs too late to prevent childhood obesity and establish lifelong healthy body weights. To break the spiralling cycle of generations of unhealthy body weights in Canadian children, and to reduce the risk of future obesity-related health problems, it is imperative to prevent excessive pregnancy weight gain, GDM and to promote a healthy prenatal and early postnatal lifestyle.
Reversing the obesity epidemic will involve a lifetime of effort by the medical and research communities, however, over the next 3 years, we believe that we may contribute to the solution by using a two-pronged approach by first targeting pregnant overweight and obese women with a healthy lifestyle approach called the Nutrition \& Exercise Lifestyle Intervention Program (NELIP) combined with a Family-based Behavioural Treatment (FBBT) that will prevent excessive weight gain and GDM, and promote a healthy fetal environment. The second prong will use this healthy lifestyle (NELIP+FBBT) approach starting at 2 months postpartum continuing to the first year, to minimize postpartum weight retention, encourage breastfeeding, and promote a healthy family lifestyle.
Primary objectives are:
- To prevent excessive pregnancy weight gain and GDM in order to decrease the incidence of macrosomia and large for gestational age babies
- To prevent weight retention postpartum and encourage healthy infant feeding practices in order to decrease the risk of developing obesity during the first year of life.
Secondary objectives are:
- To track pregnancy weight gain and postpartum weight loss, gradually reducing body weight as needed (0.5 kg per week) to achieve and maintain a healthy body weight in the mother
- To track birth weight and infant growth within the first year of life (at 2, 6 and 12 months), including body weight, height, BMI, and body fatness, using the World Health Organization growth charts as a standard.
Currently, the R. Samuel McLaughlin Foundation-Exercise and Pregnancy Lab at the University of Western Ontario is the only research laboratory in North America actively investigating metabolic changes in exercising pregnant and postpartum women. Our longitudinal aim is to reduce obesity, and chronic disease risks (such as diabetes) in the offspring of overweight and obese women using our two-pronged intervention program, which includes healthy food choices and increased physical activity (NELIP and FBBT) initiated during pregnancy and reinforced in the early postpartum period. With our NELIP team as a cornerstone, and our pilot data already collected, we foresee an opportunity over the next 3 years to contribute to intervention strategies and patient care with emphasis on disease prevention and healthy family lifestyle initiation early in life to reverse the trend of childhood obesity. With a solid research-based initiative from the lab to the community by knowledge translation to health care providers, future health care costs can be reduced by putting prevention-based programs into practice.
- Conditions
- Childhood Obesity, Excessive Weight Gain in Pregnancy With Baby Delivered, Dietary Modification, Healthy Lifestyle Habits
- Being tested
- Nutrition & Exercise Lifestyle Intervention Program (NELIP)
- Keywords
- pregnancy, intervention, exercise, nutrition, infants
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition & Exercise Lifestyle Intervention Program (NELIP)Behavioural
Also called NELIP, FBBT
Nutrition- individualize total energy intake with a minimum of 2000 kcal/day with a restriction of not more than 33% total energy intake, total carbohydrate of 40-50% total energy intake, total fat intake of 30% of total energy intake (substituting monounsaturated fatty acids for saturated and trans-fatty acids), and approximately 30% dedicated to protein intake.
Exercise-25 minutes of walking per session, 3-4 times per week, each subsequent week increasing by 2 mins to a maximum of 40 mins/session.
Family-based Behavioural Treatment (FBBT) Coupled with the individualized NELIP for each woman, FBBT will be presented in 3 group sessions (including family members), focussing on strategies to make healthy lifestyle choices with behavioural strategies.
What is being measured
The primary outcome is the main question the study is designed to answer.
To prevent excessive pregnancy weight gain and GDM to decrease incidence of macrosomia
To prevent excessive pregnancy weight gain on NELIP and GDM in order to decrease the incidence of macrosomia and large for gestational age babies (> 4.0 kg)
Measured: weekly weight gain during pregnancy and birth
Secondary outcomes (1)
To prevent weight retention in the mother and encourage healthy infant feeding practices
To prevent weight retention postpartum (gradually reducing body weight as needed by 0.5 kg per week) to achieve and maintain a healthy body weight in the mother and to encourage healthy infant feeding practices in order to decrease the risk of obesity during the first year of life.
Measured: 2, 6 and 12 months post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startMar 2009
- Primary completionDec 2013
- Study completionDec 2013
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 Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Health Research Foundation
- Responsible party
- Principal investigator, Michelle Mottola, University of Western Ontario, Canada
- Investigators
- Michelle F Mottola, PhD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129505
- Sponsor's protocol ID
- OPG-92367
- Status last verified
- Dec 2023
- First submitted
- 21 May 2010
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Mottola MF, Giroux I, Gratton R, Hammond JA, Hanley A, Harris S, McManus R, Davenport MH, Sopper MM. Nutrition and exercise prevent excess weight gain in overweight pregnant women. Med Sci Sports Exerc. 2010 Feb;42(2):265-72. doi: 10.1249/MSS.0b013e3181b5419a.
PubMed 20083959Hubbard ME, Ruchat SM, Davenport MH, Prapavessis H, Gratton R, McManus R, Giroux I, Hanley AJ, Mottola MF. Impact of an Antenatal Family-based Behavioral Treatment with a Nutrition and Exercise Lifestyle Intervention Program on Infant Weight-for-length at Birth. Int J Behav Med. 2026 Jun;33(3):402-413. doi: 10.1007/s12529-024-10345-8. Epub 2025 Jan 6.
PubMed 39762494
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Childhood Obesity: Early Intervention During Pregnancy and First Year Postpartum for Overweight and Obese Women Using a Two-pronged Family-based Nutrition & Exercise Lifestyle Intervention Program (NELIP).
- ClinicalTrials.gov ID
- NCT01129505
- Acronym / sponsor ID
- OPG-92367
- Conditions
- Childhood Obesity, Excessive Weight Gain in Pregnancy With Baby Delivered, Dietary Modification, Healthy Lifestyle Habits
- Keywords
- pregnancy, intervention, exercise, nutrition, infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Health Research Foundation
- Study start
- Mar 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 May 2010 (estimated)
- 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.
Our longitudinal aim is to reduce childhood obesity using our two-pronged intervention program, which includes healthy food choices and increased physical activity initiated during pregnancy and re-instated in the early period after delivery for overweight and obese women. We will accomplish this with our family-based Nutrition and Exercise Lifestyle Intervention Program (NELIP) to promote healthy family living. An intervention targeting school-aged children on the importance of healthy lifestyles occurs too late to prevent childhood obesity and establish lifelong healthy body weights. To break this spiraling cycle of generations of unhealthy body weights in Canadian children, and to reduce the risk of future obesity-related health problems, it is necessary to prevent excessive pregnancy weight gain, high blood sugars in the mother and to promote a healthy lifestyle during pregnancy and early post delivery. With our NELIP team as a cornerstone, and our pilot data already collected with promising results, we foresee an opportunity over the next 3 years to contribute to changing patient care with emphasis on disease prevention and healthy family lifestyle initiation early in life to reverse the trend of childhood obesity. With a solid research-based initiative from the lab to the community by educating health care providers, future health care can be improved by putting prevention-based programs into practice.
Healthy women = healthy babies = healthy families = healthy futures!!
Detailed description
Overweight and obesity have been identified as major neglected public health issues, as the prevalence of unhealthy body weights is increasing world-wide at an alarming rate. There is a robust link between the fetal environment and its long-term influence on health and susceptibility to future chronic disease in the offspring. Obesity begets obesity, and an unhealthy maternal metabolic state can have a profound influence on the risk of early obesity development in the child. Excessive pregnancy weight gain and high pre-pregnant body-mass index (BMI) have been linked to gestational diabetes (GDM) and macrosomic infants (birth weight >4.0kg. Since much of the influence of the intrauterine milieu is transmitted to the next generation non-genetically, potentially deleterious effects can be reversed and prevented. An intervention targeting school-aged children on the importance of healthy lifestyles occurs too late to prevent childhood obesity and establish lifelong healthy body weights. To break the spiralling cycle of generations of unhealthy body weights in Canadian children, and to reduce the risk of future obesity-related health problems, it is imperative to prevent excessive pregnancy weight gain, GDM and to promote a healthy prenatal and early postnatal lifestyle.
Reversing the obesity epidemic will involve a lifetime of effort by the medical and research communities, however, over the next 3 years, we believe that we may contribute to the solution by using a two-pronged approach by first targeting pregnant overweight and obese women with a healthy lifestyle approach called the Nutrition \& Exercise Lifestyle Intervention Program (NELIP) combined with a Family-based Behavioural Treatment (FBBT) that will prevent excessive weight gain and GDM, and promote a healthy fetal environment. The second prong will use this healthy lifestyle (NELIP+FBBT) approach starting at 2 months postpartum continuing to the first year, to minimize postpartum weight retention, encourage breastfeeding, and promote a healthy family lifestyle.
Primary objectives are:
- To prevent excessive pregnancy weight gain and GDM in order to decrease the incidence of macrosomia and large for gestational age babies
- To prevent weight retention postpartum and encourage healthy infant feeding practices in order to decrease the risk of developing obesity during the first year of life.
Secondary objectives are:
- To track pregnancy weight gain and postpartum weight loss, gradually reducing body weight as needed (0.5 kg per week) to achieve and maintain a healthy body weight in the mother
- To track birth weight and infant growth within the first year of life (at 2, 6 and 12 months), including body weight, height, BMI, and body fatness, using the World Health Organization growth charts as a standard.
Currently, the R. Samuel McLaughlin Foundation-Exercise and Pregnancy Lab at the University of Western Ontario is the only research laboratory in North America actively investigating metabolic changes in exercising pregnant and postpartum women. Our longitudinal aim is to reduce obesity, and chronic disease risks (such as diabetes) in the offspring of overweight and obese women using our two-pronged intervention program, which includes healthy food choices and increased physical activity (NELIP and FBBT) initiated during pregnancy and reinforced in the early postpartum period. With our NELIP team as a cornerstone, and our pilot data already collected, we foresee an opportunity over the next 3 years to contribute to intervention strategies and patient care with emphasis on disease prevention and healthy family lifestyle initiation early in life to reverse the trend of childhood obesity. With a solid research-based initiative from the lab to the community by knowledge translation to health care providers, future health care costs can be reduced by putting prevention-based programs into practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- medically pre-screened for contraindications to exercise
- prior to 16 weeks gestation (pregnancy program)
- singleton pregnancy and pre-pregnancy BMI equal or greater than 25
- before 2 months post delivery (postpartum program)
- BMI equal or greater than 25 (postpartum program)
Key exclusion criteria (1 listed)
- diagnosed with gestational diabetes or type 2 diabetes
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 |
|---|---|---|
| Nutrition & Exercise Lifestyle Intervention Program (NELIP)Also: NELIP, FBBTNutrition- individualize total energy intake with a minimum of 2000 kcal/day with a restriction of not more than 33% total energy intake, total carbohydrate of 40-50% total energy intake, total fat intake of 30% of total energy intake (substituting monounsaturated fatty acids for saturated and trans-fatty acids), and approximately 30% dedicated to protein intake. Exercise-25 minutes of walking per session, 3-4 times per week, each subsequent week increasing by 2 mins to a maximum of 40 mins/session. Family-based Behavioural Treatment (FBBT) Coupled with the individualized NELIP for each woman, FBBT will be presented in 3 group sessions (including family members), focussing on strategies to make healthy lifestyle choices with behavioural strategies. | Behavioural | – |
Primary outcome
To prevent excessive pregnancy weight gain and GDM to decrease incidence of macrosomia
Time frame: weekly weight gain during pregnancy and birth
To prevent excessive pregnancy weight gain on NELIP and GDM in order to decrease the incidence of macrosomia and large for gestational age babies (> 4.0 kg)
1 secondary outcome
To prevent weight retention in the mother and encourage healthy infant feeding practices
Time frame: 2, 6 and 12 months post delivery
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 11 Dec 2023.
- Results publication: PubMed 20083959Mottola MF, Giroux I, Gratton R, Hammond JA, Hanley A, Harris S, McManus R, Davenport MH, Sopper MM. Nutrition and exercise prevent excess weight gain in overweight pregnant women. Med Sci Sports Exerc. 2010 Feb;42(2):265-72. doi: 10.1249/MSS.0b013e3181b5419a.
- Derived from this study: PubMed 39762494Hubbard ME, Ruchat SM, Davenport MH, Prapavessis H, Gratton R, McManus R, Giroux I, Hanley AJ, Mottola MF. Impact of an Antenatal Family-based Behavioral Treatment with a Nutrition and Exercise Lifestyle Intervention Program on Infant Weight-for-length at Birth. Int J Behav Med. 2026 Jun;33(3):402-413. doi: 10.1007/s12529-024-10345-8. Epub 2025 Jan 6.
- Click for more information about this study.Link provided by the sponsor.
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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.
Michelle F Mottola, PhD principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition & Exercise Lifestyle Intervention Program (NELIP) in people with Childhood Obesity and Excessive Weight Gain in Pregnancy With Baby Delivered, run by Western University, Canada 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 5 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 11 Dec 2023. 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?
To prevent excessive pregnancy weight gain and GDM to decrease incidence of macrosomia (time frame: weekly weight gain during pregnancy and 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 NCT01129505, 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 11 Dec 2023.