A Nutrition and Exercise Lifestyle Intervention Program Participant Choice Approach
NCT ID: NCT06187675
Last Updated: 2024-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2024-01-01
2029-11-30
Brief Summary
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Detailed Description
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Nutrition component of NELIP: This component is a modified gestational diabetic meal plan that has four general goals tailored to the participant: (1) to achieve approximately 2000 kcal of energy per day. The determination of the amount of kcal consumed per day will consider the participant's intake from the dietary assessment. There also must not be a restriction of calories that exceeds 30% of their total energy intake; (2) participants will consume approximately 200-250g/day of carbohydrates, accounting for approximately 40-55% of total energy intake. Carbohydrate intake will be distributed throughout three meals and four snacks daily. The nutritionist will educate participants about the importance of complex and low-glycemic index carbohydrates through the one-on-one session; (3) fat and protein intake will be approximately 30% and 20-30% of total energy intake, respectively; (4) achieve appropriate micronutrient and fluid intake for pregnancy. This will be monitored by a weekly 24 hour food intake record.
Exercise component of NELIP: This is a walking program that comprises of 1 weekly supervised session on a treadmill or outside and participants will be recommended to walk 2 to 3 additional times per week. The walking program will start at 25 minutes per session, 3 to 4 times weekly, and increase by 2 minutes per week until 40 minutes and then maintained until delivery. This will be monitored by a wrist monitoring device. The primary outcome is adherence measured weekly using a published adherence protocol using a point system. Secondary outcomes are participant satisfaction to the program and health outcomes: weekly weight gain, calculated EGWG, and pregnancy outcomes (birth weight length, infant anthropometrics, APGAR scores and delivery complications). At 2, 6 and 12 months of age the maternal-infant dyad will return to the lab and infant morphometric measurements recorded from birth will be repeated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
Nutrition and Exercise Lifestyle Intervention Program
Nutrition and Exercise components for pregnancy
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.
Nutrition and Exercise Lifestyle Intervention Program
Nutrition and Exercise components for pregnancy
Interventions
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Nutrition and Exercise Lifestyle Intervention Program
Nutrition and Exercise components for pregnancy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* a singleton fetus
* medically screened with the Get Active Questionnaire for Pregnancy to determine eligibility for participation in the exercise component
Exclusion Criteria
* 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.
18 Years
FEMALE
Yes
Sponsors
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Western University, Canada
OTHER
Responsible Party
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Michelle Mottola
Principal Investigator
Principal Investigators
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Michelle F Mottola, PhD
Role: PRINCIPAL_INVESTIGATOR
Western University
Locations
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Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario
London, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Nagpal TS, Prapavessis H, Campbell CG, de Vrijer B, Bgeginski R, Hosein K, Paplinskie S, Manley M, Mottola MF. Sequential Introduction of Exercise First Followed by Nutrition Improves Program Adherence During Pregnancy: a Randomized Controlled Trial. Int J Behav Med. 2020 Feb;27(1):108-118. doi: 10.1007/s12529-019-09840-0.
Nagpal TS, Prapavessis H, Campbell C, Mottola MF. Measuring Adherence to a Nutrition and Exercise Lifestyle Intervention: Is Program Adherence Related to Excessive Gestational Weight Gain? Behav Anal Pract. 2017 May 17;10(4):347-354. doi: 10.1007/s40617-017-0189-5. eCollection 2017 Dec.
Mottola MF, Giroux I, Gratton R, Hammond JA, Hanley A, Harris S, McManus R, Davenport MH, Sopper MM. Nutrition and exercise prevent excess weight gain in overweight pregnant women. Med Sci Sports Exerc. 2010 Feb;42(2):265-72. doi: 10.1249/MSS.0b013e3181b5419a.
Related Links
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Exercise and Pregnancy Laboratory Website
Other Identifiers
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123317
Identifier Type: -
Identifier Source: org_study_id
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