Recruiting

NELIP

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT02155751

Conditions

Obesity

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nutrition Lifestyle Intervention Program (NLIP)

Exercise Lifestyle Intervention Program (ELIP)

Study Details

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.

Conditions

Obesity

Pregnancy

Study ID

NCT02155751

Start date

Jul, 2012

Status verified date

May, 2017

Completion date

Dec, 2017

Anticipated

Primary completion date

Sep, 2015

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient referred to "My Clinic" at London Health Sciences Centre
  • 18 or older
  • 12-20 weeks gestational age
  • Pre-pregnancy BMI >= 35kg/m2
  • Willing to be randomized

Exclusion Criteria:

  • Contraindication to walking regularly

Study Design

Enrollment

23 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Full NELIP group

These 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".

experimental: Exercise program only/ELIP

These 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.

experimental: Nutrition program only/NLIP

These 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.

no intervention: Control

A 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

Nutrition Lifestyle Intervention Program (NLIP)

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.

Exercise Lifestyle Intervention Program (ELIP)

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.

Primary outcome measure

  • Weight gain in pregnancy [ Time Frame: up to 42 weeks ]

Central Contacts and Locations

Central contacts

Debbie A Penava, MD

519-646-6401Debbie.Penava@lhsc.on.ca

Michelle Mottola, PhD

519-661-2111mmottola@uwo.ca

Locations

University of Western Ontario, London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Principal Investigator:

Debbie A Penava, MD

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

May 12, 2017

Last verified

May, 2017

Keywords

  • Obesity prevention
  • Nutrition and exercise in pregnancy
  • Postpartum
  • Maternal obesity risk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2017-05-12.