Early Prevention of Excessive Gestational Weight Gain Using Lifestyle Change

NCT ID: NCT02804061

Last Updated: 2023-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2021-01-01

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.

Conditions

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

Keywords

nutrition; exercise; behavior change; adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

NELIP

Intervention Type: BEHAVIORAL

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).

Group Type: EXPERIMENTAL

NELIP

Intervention Type: BEHAVIORAL

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).

Group Type: EXPERIMENTAL

NELIP

Intervention Type: BEHAVIORAL

Interventions

NELIP

Intervention Type: BEHAVIORAL

Other Intervention Names

Nutrition and Exercise Lifestyle Intervention Program

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Iowa State University

OTHER

Sponsor Role: collaborator

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Michelle Mottola

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle F Mottola, PhD

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

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

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 22453250 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20083959 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23969792 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29214130 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31872340 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40197635 (View on PubMed)

Other Identifiers

108080

Identifier Type: -

Identifier Source: org_study_id