A Nutrition and Exercise Lifestyle Intervention Program Participant Choice Approach

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.

NCT Number	NCT06187675
Lead Sponsor	Western University, Canada
Conditions	Lifestyle, Healthy, Pregnancy Related, Adherence, Treatment, Nutrition, Healthy, Weight Gain, Maternal
Enrollment	120 participants
Start Date	2024-01-01
Primary Completion	2028-12 (estimated)
Study Completion	2029-11 (estimated)
Updated on ClinicalTrials.gov	2024-03-05