Recruiting

Nutrition & Exercise

Sponsor:

Western University, Canada

Code:

NCT06187675

Conditions

Lifestyle, Healthy

Pregnancy Related

Adherence, Treatment

Nutrition, Healthy

Weight Gain, Maternal

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Nutrition and Exercise Lifestyle Intervention Program

Study Details

Brief summary:

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

Lifestyle, Healthy

Pregnancy Related

Adherence, Treatment

Nutrition, Healthy

Weight Gain, Maternal

Study ID

NCT06187675

Start date

Jan 1, 2024

Status verified date

Mar, 2024

Completion date

Nov, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Choice

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.

experimental: No choice

Participants will be yoked (matched) to a participant in the Choice group and they receive the same strategy as the person with a choice.

Interventions

Nutrition and Exercise Lifestyle Intervention Program

Nutrition and Exercise components for pregnancy

Primary outcome measure

  • Adherence to the intervention strategy [ Time Frame: Measured once per week from baseline (12-18 weeks gestation) to end of the intervention (34-36 weeks gestation) ]

Central Contacts and Locations

Central contacts

Michelle F Mottola, PhD

519-661-2111mmottola@uwo.ca

Locations

Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario

Recruiting

London, Ontario, Canada, N6A 3K7

Contacts

Michelle F Mottola, PhD

519-661-2111mmottola@uwo.ca

Principal Investigator:

Michelle F Mottola, PhD

More Information

Sponsor

Western University, Canada

Last update posted

Mar 5, 2024

Last verified

Mar, 2024

Keywords

  • pregnancy
  • lifestyle
  • nutrition
  • exercise
  • adherence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-06. This information was provided to ClinicalTrials.gov by Western University, Canada on 2024-03-05.