Sequential Introduction of Exercise First Followed by Nutrition Improves Program Adherence During Pregnancy: a Randomized Controlled Trial.
Taniya S Nagpal, Harry Prapavessis, Christina G Campbell...
https://pubmed.ncbi.nlm.nih.gov/31872340Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID06187675
A Participant Choice Approach to Improve Adherence and Investigate Pregnancy Outcomes to Lifestyle Interventions
Led by Western University, Canada · Updated on 2024-03-05
120
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring how giving pregnant individuals a choice among different nutrition and exercise programs affects their ability to stick to the program and maintain healthy pregnancy outcomes. The study focuses on preventing excessive gestational weight gain by comparing adherence to three lifestyle intervention strategies within the Nutrition and Exercise Lifestyle Intervention Program (NELIP). This research uses a pseudo-randomized design to examine if choice improves participation compared to no choice in pregnant individuals between 12 and 18 weeks of pregnancy with a single fetus. Participants are divided into two groups: one group chooses from three intervention strategies and the other group is matched to a choice participant and receives the same strategy without choice. The three strategies vary in timing of introducing nutrition and exercise components; either both simultaneously starting at 12-18 weeks, or nutrition first followed by exercise at 25 weeks, or exercise first followed by nutrition at 25 weeks. The exercise involves a supervised walking program with gradually increasing duration, and nutrition is based on a modified gestational diabetic meal plan tailored per participant. The full program continues until delivery, with final intervention measures between 34 and 36 weeks gestation. Participants will be monitored weekly for adherence using a point system, with additional assessments of satisfaction and health outcomes like weight gain, birth measurements, and pregnancy complications. Follow-up visits occur at birth and at 2, 6, and 12 months postpartum to track maternal and infant health. The study collects detailed data on nutrition, exercise, and pregnancy progress to understand how choice impacts adherence and outcomes over this extended timeline.
CONDITIONS
Brief Title
A Nutrition and Exercise Lifestyle Intervention Program Participant Choice Approach
Who Can Participate
Age: 18Years +
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Between 12 to 18 weeks of pregnancy
- Pregnant with a single fetus
- Medically screened and eligible for exercise participation using the Get Active Questionnaire for Pregnancy
You will not qualify if you...
- Unable to walk
- Serious medical problems
- High blood pressure
- Uncontrolled chest pain
- Uncontrolled symptomatic lung disease
- Diabetes before pregnancy
- History of recreational substance use disorder
- Any contraindication to exercise
- Enrolled in another clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - From 12-18 weeks of pregnancy until 34-36 weeks of pregnancy
Participants engage in a nutrition and exercise lifestyle intervention program during pregnancy. They either choose or are assigned to one of three strategies involving nutrition and exercise components starting between 12 to 18 weeks of pregnancy and continuing until delivery.
Weekly visits for adherence monitoring and assessments
Follow-up
Duration - Up to 12 months after birth
Participants and their infants return for follow-up visits to assess postpartum body weight and infant growth and adiposity at 2, 6, and 12 months after birth.
3 visits at 2, 6, and 12 months postpartum
Trial Site Locations
Total: 1 location
1
Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario
London, Ontario, Canada, N6A 3K7
Actively Recruiting
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Research Team
M
Michelle F Mottola, PhD
E
Edit Somogyi, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Measuring Adherence to a Nutrition and Exercise Lifestyle Intervention: Is Program Adherence Related to Excessive Gestational Weight Gain?
Taniya S Nagpal, Harry Prapavessis, Christina Campbell...
https://pubmed.ncbi.nlm.nih.gov/29214130Nutrition and exercise prevent excess weight gain in overweight pregnant women.
Michelle F Mottola, Isabelle Giroux, Robert Gratton...
https://pubmed.ncbi.nlm.nih.gov/20083959