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Early Prevention of Excessive Gestational Weight Gain Using Lifestyle Change (NELIP)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
NELIP
Sponsored by
University of Western Ontario, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Excessive Weight Gain in Pregnancy, First Trimester focused on measuring nutrition, exercise, behavior change, adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Full NELIP

Nutrition followed by Exercise (N+E)

Exercise followed by Nutrition (E+N)

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

Prevention of early excessive gestational weight gain
Calculations based on the Institute of Medicine (2009) weight gain guidelines

Secondary Outcome Measures

Prevention of total excessive gestational weight gain
Calculations based on the Institute of Medicine (2009)
Birth weight
Taken from medical records

Full Information

First Posted
June 14, 2016
Last Updated
April 5, 2021
Sponsor
University of Western Ontario, Canada
Collaborators
Iowa State University
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1. Study Identification

Unique Protocol Identification Number
NCT02804061
Brief Title
Early Prevention of Excessive Gestational Weight Gain Using Lifestyle Change
Acronym
NELIP
Official Title
Strategizing the Best Approach to Prevent Early Excessive Gestational Weight Gain Using a Nutrition and Exercise Lifestyle Intervention Program (NELIP)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Western Ontario, Canada
Collaborators
Iowa State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Excessive Weight Gain in Pregnancy, First Trimester, Excessive Weight Gain in Pregnancy With Baby Delivered, Birth Weight
Keywords
nutrition, exercise, behavior change, adherence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full NELIP
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Nutrition followed by Exercise (N+E)
Arm Type
Experimental
Arm Description
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).
Arm Title
Exercise followed by Nutrition (E+N)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
NELIP
Other Intervention Name(s)
Nutrition and Exercise Lifestyle Intervention Program
Primary Outcome Measure Information:
Title
Prevention of early excessive gestational weight gain
Description
Calculations based on the Institute of Medicine (2009) weight gain guidelines
Time Frame
Up to 24 weeks gestation
Secondary Outcome Measure Information:
Title
Prevention of total excessive gestational weight gain
Description
Calculations based on the Institute of Medicine (2009)
Time Frame
Up to 38 weeks of pregnancy or last known pregnancy weight
Title
Birth weight
Description
Taken from medical records
Time Frame
At Birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle F Mottola, PhD
Organizational Affiliation
University of Western Ontario, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22453250
Citation
Ruchat SM, Davenport MH, Giroux I, Hillier M, Batada A, Sopper MM, Hammond JM, Mottola MF. Nutrition and exercise reduce excessive weight gain in normal-weight pregnant women. Med Sci Sports Exerc. 2012 Aug;44(8):1419-26. doi: 10.1249/MSS.0b013e31825365f1.
Results Reference
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PubMed Identifier
20083959
Citation
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.
Results Reference
background
PubMed Identifier
23969792
Citation
Davenport MH, Ruchat SM, Giroux I, Sopper MM, Mottola MF. Timing of excessive pregnancy-related weight gain and offspring adiposity at birth. Obstet Gynecol. 2013 Aug;122(2 Pt 1):255-261. doi: 10.1097/AOG.0b013e31829a3b86.
Results Reference
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PubMed Identifier
29214130
Citation
Nagpal TS, Prapavessis H, Campbell C, Mottola MF. Measuring Adherence to a Nutrition and Exercise Lifestyle Intervention: Is Program Adherence Related to Excessive Gestational Weight Gain? Behav Anal Pract. 2017 May 17;10(4):347-354. doi: 10.1007/s40617-017-0189-5. eCollection 2017 Dec.
Results Reference
background
PubMed Identifier
31872340
Citation
Nagpal TS, Prapavessis H, Campbell CG, de Vrijer B, Bgeginski R, Hosein K, Paplinskie S, Manley M, Mottola MF. Sequential Introduction of Exercise First Followed by Nutrition Improves Program Adherence During Pregnancy: a Randomized Controlled Trial. Int J Behav Med. 2020 Feb;27(1):108-118. doi: 10.1007/s12529-019-09840-0.
Results Reference
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Early Prevention of Excessive Gestational Weight Gain Using Lifestyle Change

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