Adherence to Different Exercise Interventions

Aherence to Different Exercise Interventions

Only 50% of sedentary adults that start an exercise training program adhere to the program after 6 months. Exercise variety may improve adherence. The goal of this study is to examine different exercise interventions that include a variety of exercise on adherence.

Study Overview

• Status: Recruiting
• Conditions: Exercise Adherence
• Intervention / Treatment: Behavioral: Walking; Behavioral: Variety; Behavioral: Progressive

Detailed Description

Regular exercise, in the form of walking 150 minutes per week, is widely regarded as having many health and fitness benefits. Despite these well-known benefits, adherence to exercise interventions is extremely low. When sedentary adults start an exercise training program only 50% adhere to the program and meet the national recommendations of 150 minutes per week. A possible explanation of the low adherence is that most adults only walk for exercise, and that providing a variety of exercise may increase adherence. Preliminary observational data show that a variety of exercise may increase weekly exercise expenditure compared to other interventions. The overall objective of this study is to investigate the feasibility, adherence, and acceptability of different exercise interventions including 1) walk intervention, 2) variety intervention, and 3) progressive intervention (see below for description).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Todd Hagobian, PhD; Phone Number: 8057567511; Email: thagobia@calpoly.edu
• Study Contact Backup: Name: Adam Seal, PhD; Phone Number: 8057562545; Email: adseal@calpoly.edu

Study Locations

• United States
  • California
    • San Luis Obispo, California, United States, 93407
      • Recruiting
      • California Polytechnic State University
      • Contact: Eric Benson; Phone Number: 805-756-7525; Email: ecbenson@calpoly.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 18-40 years old
• Sedentary (<1 hour per week of exercise)
• BMI 18.5 to 40 kg/m2

Exclusion Criteria:

• Adults with diagnosed cardiovascular, diabetes, renal, or any other metabolic disease determined by Health and Fitness History questionnaire.
• Any other disability, ailment, or physical characteristics that may hinder the ability to participate in regular exercise determined by Health and Fitness History questionnaire.
• Participating in other studies that would interfere with their ability to safely complete the exercise protocols.
• Pregnant or trying to become pregnant, and peri-menopausal or post-menopausal women.
• History of smoking within the last 6 months
• Any other vulnerable population (children <18, pregnant women, prisoners, etc.)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Walking; Participants prescribed 150 minutes/week of moderate to vigorous walking.	Behavioral: Walking; Prescribed 150 minutes per week of moderate to vigorous walking.
Experimental: Variety; Participants prescribed 150 minutes/week of moderate to vigorous variety of exercise. Each week participants will be prescribed a single different exercise (variety) which will include cycling, walking/jogging, yoga/Pilates, and cross-training.	Behavioral: Variety; Prescribed 150 minutes per week of moderate to vigorous variety of exercise. Each week participants are randomly asked to participate in cycling, walking/jogging, yoga/Pilates, or cross-training.
Experimental: Progressive; Participants prescribed 150 minutes/week of moderate to vigorous exercise. The exercises include cycling, walking/jogging, yoga/Pilates, and cross-training, and each week another exercise will be added to the list of options for participants. Participants may choose from the list of exercise. They do not have to do them all, and they can do as much or little (none) of whatever they choose.	Behavioral: Progressive; Prescribed 150 minutes per week of moderate to vigorous progressive variety of exercise. Each week participants are randomly asked to participate in cycling, walking/jogging, yoga/Pilates, or cross-training. Participants can choose which exercise they want to do, and can do as much or little as they want.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to exercise intervention	Adherence is assessed as meeting or exceeding 150 minutes per week of moderate to vigorous exercise	Change from baseline at 1-week, 2-weeks, 3-weeks, and 4-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of intervention	Participants will complete a survey on acceptability at the end of the exercise intervention	Acceptability at 4-weeks
Body Weight	Body weight will be measured at baseline and 4-weeks	Change in body weight from baseline to 4-weeks

Collaborators and Investigators

• Sponsor: California Polytechnic State University-San Luis Obispo
• Investigators: Principal Investigator: Todd Hagobian, California Polytechnic State University-San Luis Obispo

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: July 1, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2023-152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data and documentation will be available under a data-sharing agreement. Information shared with outside collaborators will link data to two unique study identifiers (de-Identified) to maintain participant anonymity, and outside researchers and the community will not be allowed to have access to participant names and confidential information.
• IPD Sharing Time Frame: Seven years after the date of the last participant completing the study.
• IPD Sharing Access Criteria: Contact PI and a date-sharing agreement will be created that provides for (1) a commitment to use the data for research purposes only; (2) a commitment to securing the data using appropriate computer technology (password protected and encrypted); (3) a commitment to destroying or returning the data after analyses are completed and (4) a commitment not to attempt to identify participants individually.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

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