An interventional study of NELIP in Excessive Weight Gain in Pregnancy, First Trimester, Excessive Weight Gain in Pregnancy With Baby Delivered and Birth Weight, sponsored by Western University, Canada. Completed at 1 site in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-08.
Sponsored by Western University, Canada · Not applicable, Interventional, and Prevention
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).
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.
446 studies on the registry are indexed under Birth Weight; 36 are open to participants now.
This study's enrollment of 142 is above the median of 110 across 299 interventional studies indexed under Birth Weight.
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Exclusion Criteria:
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
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
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
Also known as: Nutrition and Exercise Lifestyle Intervention Program
Prevention of early excessive gestational weight gain
Calculations based on the Institute of Medicine (2009) weight gain guidelines
Time frame: Up to 24 weeks gestation
Prevention of total excessive gestational weight gain
Calculations based on the Institute of Medicine (2009)
Time frame: Up to 38 weeks of pregnancy or last known pregnancy weight
Birth weight
Taken from medical records
Time frame: At Birth
Plan to share: No
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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