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Behavioural Intervention
No choice for Healthy Lifestyle (NELIP Trial)
N/A
Recruiting
Led By Michelle F Mottola, PhD
Research Sponsored by Western University, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between 12 to 18 weeks of pregnancy, with a singleton fetus
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured weekly from 12-18 weeks of pregnancy to 34-36 weeks of pregnancy
Awards & highlights
NELIP Trial Summary
This trial is looking at different ways to help pregnant individuals prevent excessive weight gain during pregnancy. They want to see if giving participants a choice of intervention strategies will improve their adherence to the program. The three
Who is the study for?
This trial is for pregnant individuals interested in managing weight gain through a healthy lifestyle. Participants should be willing to adhere to a nutrition and exercise program, with no major health issues that would limit their ability to follow the intervention.Check my eligibility
What is being tested?
The study tests how giving participants a choice affects adherence to a lifestyle program aimed at preventing excessive weight gain during pregnancy. It compares three strategies: simultaneous nutrition and exercise introduction, staggered introduction of each component, or following an established full program from mid-pregnancy.See study design
What are the potential side effects?
As this is a nutrition and exercise intervention, side effects are minimal but may include typical risks associated with new diets or physical activity such as muscle soreness or dietary adjustments.
NELIP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 12 to 18 weeks pregnant with one baby.
NELIP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured weekly from 12-18 weeks of pregnancy to 34-36 weeks of pregnancy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured weekly from 12-18 weeks of pregnancy to 34-36 weeks of pregnancy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to the intervention strategy
Secondary outcome measures
Birth circumferences
Birth length
Birth skinfolds
+10 moreNELIP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: No choiceExperimental Treatment1 Intervention
Participants will be yoked (matched) to a participant in the Choice group and they receive the same strategy as the person with a choice.
Group II: ChoiceActive Control1 Intervention
Participants will be given a choice of 3 strategies; Group A - they receive both nutrition and exercise components simultaneously, Group B - they receive the nutrition component first followed by introduction of the exercise component sequentially, or Group C - they receive the exercise component first followed by introduction of the nutrition component sequentially.
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Who is running the clinical trial?
Western University, CanadaLead Sponsor
239 Previous Clinical Trials
56,801 Total Patients Enrolled
Michelle F Mottola, PhDPrincipal InvestigatorWestern University
5 Previous Clinical Trials
471 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants currently being actively recruited for this trial?
"As per clinicaltrials.gov, this particular clinical trial is not currently actively seeking participants. The study was first posted on January 1st, 2024 and the most recent update was made on December 18th, 2023. However, there are presently 316 other studies that are accepting patients at this time."
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