CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 142 enrolled
Drug / intervention
NELIPbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02804061
NCT02804061N/ACompleted

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

Western University, Canada·interventional·Posted Jun 17, 2016·Updated Dec 8, 2023

In Brief

A clinical study evaluating NELIP for Excessive Weight Gain in Pregnancy, First Trimester and 2 related conditions. Completed, enrolled 142 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 17, 2016
Enrollment StartJul 1, 2016
Primary CompletionJan 1, 2021
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 10.0 years ago

Interventions

NELIPbehavioral