NCT01129505

Brief 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. 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!!

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 24, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

4.8 years

First QC Date

May 21, 2010

Last Update Submit

December 4, 2023

Conditions

Keywords

pregnancyinterventionexercisenutritioninfants

Outcome Measures

Primary Outcomes (1)

  • 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)

    weekly weight gain during pregnancy and birth

Secondary Outcomes (1)

  • To prevent weight retention in the mother and encourage healthy infant feeding practices

    2, 6 and 12 months post delivery

Interventions

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.

Also known as: NELIP, FBBT

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • diagnosed with gestational diabetes or type 2 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario

London, Ontario, N6A 3K7, Canada

Location

Related Publications (2)

  • 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.

  • Hubbard 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. 2025 Jan 6. doi: 10.1007/s12529-024-10345-8. Online ahead of print.

Related Links

MeSH Terms

Conditions

Pediatric ObesityMotor Activity

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Michelle F Mottola, PhD

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Michelle F. Mottola, FACSM

Study Record Dates

First Submitted

May 21, 2010

First Posted

May 24, 2010

Study Start

March 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 11, 2023

Record last verified: 2023-12

Locations