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Behavioural Intervention

Nutrition and Exercise for Pregnancy Weight Gain (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

Must not have

Inability to walk

Serious medical problems such as high blood pressure, uncontrolled chest pain, uncontrolled symptomatic lung disease, diabetes before pregnancy and/or a history of recreational substance use disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured weekly from 12-18 weeks of pregnancy to 34-36 weeks of pregnancy

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 12 to 18 weeks pregnant with one baby.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot walk.

Select...

I have no uncontrolled serious health issues or history of substance abuse.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured weekly from 12-18 weeks of pregnancy to 34-36 weeks of pregnancy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence to the intervention strategy

Secondary study objectives

Birth circumferences

Birth length

Birth skinfolds

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met