A Nutrition and Exercise Lifestyle Intervention Program Participant Choice Approach (NELIP)

A Participant Choice Approach to Improve Adherence and Investigate Pregnancy Outcomes to Lifestyle Interventions

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related; Lifestyle, Healthy; Nutrition, Healthy; Adherence, Treatment; Weight Gain, Maternal
• Intervention / Treatment: Behavioral: Nutrition and Exercise Lifestyle Intervention Program

Detailed Description

Investigators are using a pseudo randomized yoked design and will include two groups: choice of intervention strategy or no-choice. If the individual is randomized to no choice, then the next person would get a choice and the no choice person would be assigned to the group yoked (matched) to the person with a choice. Participants assigned to the choice group will choose one of three intervention strategies provided; either Group A (receiving both nutrition and exercise simultaneously), B (starting with nutrition and receiving exercise sequentially followed by nutrition starting at 25 weeks) or C (starting with nutrition first and then introducing exercise sequentially at 25 weeks). All groups will follow the full NELIP until delivery. Participants in the no-choice group will be yoked (matched) to a participant in the choice group and receive the strategy that their yoked counterparts chose.

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle F Mottola, PhD; Phone Number: 85480 519-661-2111; Email: mmottola@uwo.ca
• Study Contact Backup: Name: Edit Somogyi, PhD; Phone Number: 88366 519-661-2111; Email: esomogyi@uwo.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 3K7
      • Recruiting
      • Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario
      • Contact: Michelle F Mottola, PhD; Phone Number: 88366 519-661-2111; Email: mmottola@uwo.ca
      • Principal Investigator: Michelle F Mottola, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Nutrition and Exercise Lifestyle Intervention Program; Nutrition and Exercise components for pregnancy; Other Names: NELIP
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.	Behavioral: Nutrition and Exercise Lifestyle Intervention Program; Nutrition and Exercise components for pregnancy; Other Names: NELIP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant satisfaction	Satisfaction Survey assessed on a 5-point Likert scale; ranging from 1 for very unsatisfied to 5 for very satisfied.	Measured at 34-36 weeks of pregnancy at the end of the intervention
Gestational weight gain	Weight gained measured in kg and compared to the Institute of Medicine 2009 weight gain guidelines	Measured weekly from 12-18 weeks of pregnancy to 34-36 weeks of pregnancy
Birth weight	Birth weight (measured in kg)	Measured within 6 to 18 hours after delivery
Birth length	Birth Length (measured in cms)	Measured within 6 to 18 hours after delivery
Birth circumferences	Newborn circumferences (arm, forearm, thigh, leg, abdomen, chest, and head - measured in cm)	Measured within 6 to 18 hours after delivery
Birth skinfolds	Newborn skinfolds (biceps, triceps, subscapular, suprailiac, anterior thigh - measured in mm)	Measured within 6 to 18 hours after delivery
Pregnancy outcome	APGAR scores (measured out of 10 at 1 minutes and 5 minutes after birth)	Measured within 6 to 18 hours after delivery
Pregnancy complications	Pregnancy complications (recorded)	Measured within 6 to 18 hours after delivery
Postpartum body weight	Participant body weight (measured in kg)	2, 6 and 12 months after birth
Follow-up Infant weight	Infant weight (measured in kg)	2, 6 and 12 months after birth
Follow-up Infant length	Infant length (measured in cm)	2, 6 and 12 months after birth
Follow-up Infant Girths	Infant circumferences (arm, forearm, thigh, leg, abdomen, chest, head - measured in cm)	2, 6 and 12 months after birth
Follow-up Infant adiposity	Infant skinfold measurements (biceps, triceps, subscapular, suprailiac, anterior thigh - measured in mm)	2, 6 and 12 months after birth

Collaborators and Investigators

• Sponsor: Western University, Canada
• Investigators: Principal Investigator: Michelle F Mottola, PhD, Western University

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Exercise and Pregnancy Laboratory Website

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: exercise; adherence; nutrition; pregnancy; lifestyle
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain; Gestational Weight Gain
• Other Study ID Numbers: 123317

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: deidentified data may be shared after publication
• IPD Sharing Time Frame: After completion of the study and after publication
• IPD Sharing Access Criteria: Access with be determined by the principal investigator once the reasons for data acquisition are given
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No