Early Prevention of Excessive Gestational Weight Gain Using Lifestyle Change

Birth Weight Clinical Trial

— NELIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02804061
• Other study ID #: 108080
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: January 1, 2021

Study information

• Verified date: November 2023
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• NELIP

Locations

Country	Name	City	State
Canada	Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Western University, Canada	Iowa State University

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View 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. — View 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/s40617-0 — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of early excessive gestational weight gain	Calculations based on the Institute of Medicine (2009) weight gain guidelines	Up to 24 weeks gestation
Secondary	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
Secondary	Birth weight	Taken from medical records	At Birth