Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT06187675

A Nutrition and Exercise Lifestyle Intervention Program Participant Choice Approach

Led by Western University, Canada · Updated on 2024-03-05

120

Participants Needed

1

Research Sites

304 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Interventions that target excessive gestational weight gain (EGWG) with nutrition and exercise behavior change struggle with low program adherence. The investigators recently examined adherence in a randomized controlled trial to a previously established lifestyle program called the Nutrition and Exercise Lifestyle Intervention Program (NELIP) and found that those individuals with high adherence to the program were more likely to prevent EGWG. Perhaps offering participants a choice to intervention strategies may improve adherence. The current research question is: What impact does participant choice have on adherence to the introduction of nutrition and exercise components during 3 intervention strategies offered to pregnant individuals compared to no choice and does choice maintain pregnancy health outcomes? The strategies are: Group A - introducing both the nutrition and exercise components simultaneous at baseline (12-18 weeks of pregnancy) that is followed to delivery (NELIP); Group B - introducing the nutrition component first and then at 25 weeks adding the exercise component; or Group C - starting with the exercise component first, followed with introducing the nutrition component at 25 weeks. Both Groups B and C follow the full NELIP from 25 weeks to delivery (final intervention measures will occur at 34-36 weeks gestation). Follow-up will occur at birth (6-18 hours), 2, 6 and 12 months post delivery.

CONDITIONS

Official Title

A Nutrition and Exercise Lifestyle Intervention Program Participant Choice Approach

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 12 to 18 weeks of pregnancy
  • Pregnant with a single fetus
  • Medically eligible for exercise based on the Get Active Questionnaire for Pregnancy
Not Eligible

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
  • Currently enrolled in another clinical trial

AI-Screening

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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

CONTACT

E

Edit Somogyi, PhD

CONTACT

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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