Early Prevention of Excessive Gestational Weight Gain Using Lifestyle Change

Study Overview
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Brief Summary
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Nutrition and exercise behaviour change programs can prevent excessive gestational weight gain (EGWG). The Nutrition and Exercise Lifestyle Intervention Program (NELIP) is a previously published two-behaviour change program which was successful in preventing EGWG across normal weight, overweight and obese pre-pregnancy body mass index (BMI) categories (Ruchat et al. 2012; Mottola et al. 2010), however some women found it difficult to adhere to two lifestyle behaviour changes throughout pregnancy. The proposed pilot randomized controlled trial will address the issue of adherence by identifying the best way to offer a two-behaviour change program (NELIP) to pregnant women to increase the effectiveness of preventing early and total EGWG. Participants will begin the program at <18 weeks gestation and will be randomized to one of three groups: A) Receive both behaviour changes (Nutrition AND Exercise) simultaneously at entrance to the study; B) Receive the nutrition component first followed sequentially by the introduction of exercise at 25 weeks gestation (Nutrition FOLLOWED by Exercise); C) Receive the exercise component first followed sequentially by the introduction of the nutrition component at 25 weeks gestation (Exercise FOLLOWED by Nutrition).

Detailed Description
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A randomized parallel groups design will be used as a pilot project. Each participant will be medically pre-screened using the PARmed-X for Pregnancy (2015) in early pregnancy (<18 weeks), stratified by pre-pregnancy BMI status (normal weight [18.5-24.9 kg/m2]; overweight [25.0-29.9 kg/m2], obese [=>30.0 kg/m2]) and randomized into one of 3 groups: Group A) NELIP (full intervention); Group B) Nutrition intervention given at study entry followed sequentially by the exercise intervention starting immediately after 24 week mid-way visit (N+E); or Group C) Exercise intervention started at study entry followed sequentially by the nutrition intervention starting immediately after 24 week mid-way visit (E+N). Infant sex, body weight, length, complications will be recorded at birth and the last known maternal body weight. Neonatal morphometrics will be assessed with diaper only (6 skinfold sites from umbilical, suprailiac, biceps, triceps, subscapular, and anterior thigh; circumferences from the head, chest, abdomen, hips, thigh, leg, arm, and arm, forearm, thigh and leg length measured to the nearest mm) and will be measured within 6-18 hours of delivery by a member of the research team visiting the woman either at hospital or home. Each maternal-infant pair will be asked to return to the lab at 2, 6 and 12 months post-delivery for follow-up and assessment of chronic disease risk.

Official Title
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Strategizing the Best Approach to Prevent Early Excessive Gestational Weight Gain Using a Nutrition and Exercise Lifestyle Intervention Program (NELIP)

Conditions
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Excessive Weight Gain in Pregnancy, First Trimester, Excessive Weight Gain in Pregnancy With Baby Delivered, Birth Weight

Intervention / Treatment
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* Behavioral: NELIP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: single pregnancy (no twins); < 18 weeks, 0 days pregnant at time of entry to study; low-risk pregnancy, as determined by medical pre-screening via PARmed-X for Pregnancy by their health care provider; > 18 years of age; low physical activity defined as less than 3 intentional bouts of 30 minutes of moderately intense physical activity per week; non smokers. Exclusion Criteria: multiple pregnancy (twins, etc); contraindication to exercise (includes chronic diseases such as cardiovascular diseases, thyroid diseases, uncontrolled Type 2 diabetes, peripheral vascular disease, hypertension); > 18 weeks, 0 days pregnant at time of entrance to study; <18 years of age; high physical activity defined as more than 3 intentional bouts of 30 minutes of moderately intense physical activity per week; smokers.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Full NELIP<br>This group will receive the full Nutrition and Exercise Lifestyle Intervention Program (two behavior changes) from enrollment until birth and serves as the comparator control (Group A). | Behavioral: NELIP<br> <br> * Other names: Nutrition and Exercise Lifestyle Intervention Program;|
| Experimental: Nutrition followed by Exercise (N+E)<br>Intervention - Nutrition component only (one behaviour) until 24 week assessment, then the addition of the second behavior change (Exercise component) at 25 weeks, with both behaviours followed until birth (Group B). | Behavioral: NELIP<br> <br> * Other names: Nutrition and Exercise Lifestyle Intervention Program;|
| Experimental: Exercise followed by Nutrition (E+N)<br>Intervention - Exercise component only (one behaviour) until 24 week assessment, after which there will be the addition of the second behaviour change (Nutrition component), with both behaviours followed until birth (Group C). | Behavioral: NELIP<br> <br> * Other names: Nutrition and Exercise Lifestyle Intervention Program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of early excessive gestational weight gain | Calculations based on the Institute of Medicine (2009) weight gain guidelines | Up to 24 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of total excessive gestational weight gain | Calculations based on the Institute of Medicine (2009) | Up to 38 weeks of pregnancy or last known pregnancy weight | 
| Birth weight | Taken from medical records | At Birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition, exercise, behavior change, adherence