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

November 30, 2023 updated by: Michelle Mottola, Western University, Canada

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 3K7
        • Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Full NELIP
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
Other Names:
  • Nutrition and Exercise Lifestyle Intervention Program
Experimental: Nutrition followed by Exercise (N+E)
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
Other Names:
  • Nutrition and Exercise Lifestyle Intervention Program
Experimental: Exercise followed by Nutrition (E+N)
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
Other Names:
  • Nutrition and Exercise Lifestyle Intervention Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevention of early excessive gestational weight gain
Time Frame: Up to 24 weeks gestation
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
Time Frame: Up to 38 weeks of pregnancy or last known pregnancy weight
Calculations based on the Institute of Medicine (2009)
Up to 38 weeks of pregnancy or last known pregnancy weight
Birth weight
Time Frame: At Birth
Taken from medical records
At Birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University, Canada

Collaborators

Iowa State University

Investigators

  • Principal Investigator: Michelle F Mottola, PhD, Western University, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

June 16, 2016

First Posted (Estimated)

June 17, 2016

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 108080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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