Bringing NELIP for Obese Pregnant Women Into Clinical Practice
Bringing an Evidence-based Nutrition and Exercise Lifestyle Intervention Program (NELIP) for Obese Pregnant Women Into Clinical Practice
1 other identifier
interventional
23
1 country
1
Brief Summary
This is a pilot project in which investigators will recruit obese (pre-pregnancy BMI of ≥ 35 kg/m2) women from the newly developed "My Clinic" at London Health Sciences Centre as well as normal obstetrical care at London Health Sciences Centre. Patients will be randomized to one of three treatment groups: 1) the full Nutrition and Exercise Lifestyle Intervention Program (NELIP), 2) Nutrition program only, or 3) Exercise program only. The investigators hypothesize that the evidence-based NELIP for obese pregnant women will be feasible to adopt in a clinical setting and will prevent excessive gestational weight gain, gestational diabetes and promote healthy infant growth patterns at the 6 and 12 month milestones. Outcomes may be improved in My Clinic over normal obstetrical care patients with interprofessional services.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Jul 2012
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 11, 2013
CompletedFirst Posted
Study publicly available on registry
June 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMay 12, 2017
May 1, 2017
3.2 years
October 11, 2013
May 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight gain in pregnancy
Average weekly weight gain and total weight gained throughout pregnancy; recorded from initial recruitment (12-20 weeks GA) to date of delivery (up to 42 weeks). This would include approximately 20 weeks on average of follow-up in the clinic, but up to a maximum of 30 weeks total. Women are assessed at 6 months post partum and weight change measured also.
up to 42 weeks
Secondary Outcomes (6)
Infant birth weight
Measured at time of birth
Neonatal morphometrics
Measured at birth, 6 months postpartum, 12 months postpartum
Birth complications
Measured at time of birth
Breast feeding
Measured at birth, 6 months postpartum, 12 months postpartum
Maternal weight retention
Measured at 6 and 12 months postpartum
- +1 more secondary outcomes
Study Arms (4)
Full NELIP group
EXPERIMENTALThese women (n=10) will receive the full NELIP intervention and will be introduced to both the dietary program and the exercise program as described above under "detailed description".
Exercise program only/ELIP
EXPERIMENTALThese women (n=10) will only be given the exercise component (ELIP) of NELIP, as outlined below in interventions. Once dietary intake has been assessed, this group will not be given any dietary intervention but will be encouraged to eat a healthy, balanced diet. Access to the nutritionist in the clinic is available and encouraged.
Nutrition program only/NLIP
EXPERIMENTALThese women (n=10) will only be given the nutrition program (NLIP) of NELIP as outlined below in intervention. They will be encouraged to be more active but will not be given an exercise intervention.
Control
NO INTERVENTIONA control group (n=30) of obese pregnant women will also be recruited and will be matched by pre-pregnancy BMI, maternal age and parity, with no intervention, but will attend the clinic for standard obstetric care and follow-up.
Interventions
The dietary program will mimic the gestational diabetic meal plan: a) individualize total energy intake with a minimum of 2000 kcal/day (8360 kJ/day), taking into account the usual energy intake as indicated by each dietary assessment (including 3-day food intake records) with a restriction of not more than 33% total energy intake; b) adjust if necessary the total carbohydrate intake to 40-50% of total energy intake, distributing carbohydrate intake throughout the day with three balanced meals, and three snacks per day emphasizing complex carbohydrates and low glycemic index foods; c) adjust the total fat intake to 30% of total energy intake (substituting monounsaturated fatty acids for saturated and trans-fatty acids), with the remaining 30% dedicated to protein intake; and d) meet all micronutrient and fluid needs recommended during pregnancy.
The exercise program includes a walking program in which pregnant women walk for 25 minutes, 3 to 4 times per week, adding 2 minutes each week, until 40 minutes is reached and then maintained until delivery. Each woman will be given a pedometer and log sheet to keep track of daily steps and to initiate self-monitoring behaviour.
Eligibility Criteria
You may qualify if:
- Patient referred to "My Clinic" at London Health Sciences Centre
- or older
- weeks gestational age
- Pre-pregnancy BMI \>= 35kg/m2
- Willing to be randomized
You may not qualify if:
- Contraindication to walking regularly
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Western Ontario, London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
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.
PMID: 20083959BACKGROUNDHealth Canada. Nutrition for a health pregnancy: National guidelines for the childbearing years. Ottawa (ON): Minister of Public Works & Government Services Canada (CA); 2010.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Debbie A Penava, MD
London Health Sciences Centre
- PRINCIPAL INVESTIGATOR
Michelle Mottola, PhD
Western University, Canada
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Debbie Penava
Study Record Dates
First Submitted
October 11, 2013
First Posted
June 4, 2014
Study Start
July 1, 2012
Primary Completion
September 1, 2015
Study Completion
December 1, 2017
Last Updated
May 12, 2017
Record last verified: 2017-05