A Nutrition and Exercise Lifestyle Intervention Program Participant Choice Approach

NCT06187675 | Recruiting

• 1 other identifier: 123317
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

pregnancy; lifestyle; nutrition; exercise; adherence

Outcome Measures

Primary Outcomes (1)

• Adherence to the intervention strategy

  Percent of participants adherent to the strategies measured by a published Adherence Scale giving a score out of 3 for each component (nutrition and exercise).

  Measured once per week from baseline (12-18 weeks gestation) to end of the intervention (34-36 weeks gestation)

Secondary Outcomes (13)

• Participant satisfaction

  Measured at 34-36 weeks of pregnancy at the end of the intervention

• Gestational weight gain

  Measured weekly from 12-18 weeks of pregnancy to 34-36 weeks of pregnancy

• Birth weight

  Measured within 6 to 18 hours after delivery

• Birth length

  Measured within 6 to 18 hours after delivery

• Birth circumferences

  Measured within 6 to 18 hours after delivery

Study Arms (2)

Choice

ACTIVE COMPARATOR

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.

Behavioral: Nutrition and Exercise Lifestyle Intervention Program

No choice

EXPERIMENTAL

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

Behavioral: Nutrition and Exercise Lifestyle Intervention Program

Interventions

Nutrition and Exercise Lifestyle Intervention Program BEHAVIORAL

Nutrition and Exercise components for pregnancy

Also known as: NELIP

Choice; No choice

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All gender identities will be accepted as these individuals must be pregnant.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

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

London, Ontario, N6A 3K7, Canada

RECRUITING

Related Publications (3)

• 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.

  PMID: 31872340 BACKGROUND

• 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.

  PMID: 29214130 BACKGROUND

• 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.

  PMID: 20083959 BACKGROUND

Related Links

• Exercise and Pregnancy Laboratory Website

MeSH Terms

Conditions

Treatment Adherence and Compliance; Gestational Weight Gain; Motor Activity

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Michelle F Mottola, PhD

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle F Mottola, PhD

CONTACT

519-661-2111; mmottola@uwo.ca

Edit Somogyi, PhD

CONTACT

519-661-2111; esomogyi@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: data analysis will be analysed blinded to group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: pseudo randomized yoked design

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: January 2, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): November 1, 2029
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After completion of the study and after publication
• Access Criteria: Access with be determined by the principal investigator once the reasons for data acquisition are given

Locations

CA (1)