A Nutrition and Exercise Lifestyle Intervention Program Participant Choice Approach

Recruiting now · Not applicable

Conditions studied: Lifestyle, Healthy, Pregnancy Related, Adherence, Treatment, Nutrition, Healthy, Weight Gain, Maternal

In brief

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.

Key facts

Study ID

NCT06187675

Run by

Western University, Canada

People needed

120

Starts

2024-01-01

Expected to finish

2029-11-01

Last updated by the study team

2024-03-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• between 12 to 18 weeks of pregnancy
• a singleton fetus
• medically screened with the Get Active Questionnaire for Pregnancy to determine eligibility for participation in the exercise component

You may not qualify if…

• inability to walk
• serious medical problems
• high blood pressure
• uncontrolled chest pain
• uncontrolled symptomatic lung disease
• diabetes before pregnancy
• a history of recreational substance use disorder
• any contraindication to exercise
• enrolled in another clinical trial.

Where it is running

• Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario — London, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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