Early Prevention of Excessive Gestational Weight Gain Using Lifestyle Change

NCT02804061 | Completed

• 1 other identifier: 108080
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

nutrition; exercise; behavior change; adherence

Outcome Measures

Primary Outcomes (1)

• Prevention of early excessive gestational weight gain

  Calculations based on the Institute of Medicine (2009) weight gain guidelines

  Up to 24 weeks gestation

Secondary Outcomes (2)

• Prevention of total excessive gestational weight gain

  Up to 38 weeks of pregnancy or last known pregnancy weight

• Birth weight

  At Birth

Study Arms (3)

Full NELIP

ACTIVE COMPARATOR

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

Nutrition followed by Exercise (N+E)

EXPERIMENTAL

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

Exercise followed by Nutrition (E+N)

EXPERIMENTAL

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

Interventions

NELIP BEHAVIORAL

Also known as: Nutrition and Exercise Lifestyle Intervention Program

Exercise followed by Nutrition (E+N); Full NELIP; Nutrition followed by Exercise (N+E)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University, Canada: lead
• Iowa State University: collaborator

Study Sites (1)

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

London, Ontario, N6A 3K7, Canada

Location

Related Publications (6)

• 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.

  PMID: 22453250 BACKGROUND

• 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.

  PMID: 20083959 BACKGROUND

• 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.

  PMID: 23969792 BACKGROUND

• 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.

  PMID: 29214130 RESULT

• 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.

  PMID: 31872340 RESULT

• Bgeginski R, Nagpal TS, Hosein K, Manley M, Paplinskie S, Prapavessis H, Campbell CG, DE Vrijer B, Mottola MF. Does Delivery of a Nutrition and Exercise Intervention Simultaneously or Sequentially Prevent Excessive Gestational Weight Gain? The NELIP Trial. Med Sci Sports Exerc. 2025 Sep 1;57(9):2032-2039. doi: 10.1249/MSS.0000000000003729. Epub 2025 Apr 8.

  PMID: 40197635 DERIVED

MeSH Terms

Conditions

Birth Weight; Motor Activity

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Michelle F Mottola, PhD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 17, 2016
• Study Start: July 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: December 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)