NCT06024577

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
26mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Aug 2023Jul 2028

First Submitted

Initial submission to the registry

July 1, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 18, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

3.9 years

First QC Date

July 1, 2023

Last Update Submit

September 1, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Acceptability of intervention

    Acceptability at 4-weeks

  • Body Weight

    Change in body weight from baseline to 4-weeks

Study Arms (3)

Walking

ACTIVE COMPARATOR

Participants prescribed 150 minutes/week of moderate to vigorous walking.

Behavioral: Walking

Variety

EXPERIMENTAL

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

Progressive

EXPERIMENTAL

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

Interventions

WalkingBEHAVIORAL

Prescribed 150 minutes per week of moderate to vigorous walking.

Walking
VarietyBEHAVIORAL

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.

Variety
ProgressiveBEHAVIORAL

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.

Progressive

Eligibility Criteria

Age18 Years - 40 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsGender criteria are: * Cisgender man (non transgender) * Cisgender woman (non transgender) * Transgender man * Transgender woman
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Polytechnic State University

San Luis Obispo, California, 93407, United States

RECRUITING

MeSH Terms

Interventions

Walking

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Todd Hagobian

    California Polytechnic State University-San Luis Obispo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Todd Hagobian, PhD

CONTACT

Adam Seal, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Research staff collecting data will be masked to intervention
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized study to three arms: 1) walk intervention, 2) variety intervention, 3) progressive intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair and Professor

Study Record Dates

First Submitted

July 1, 2023

First Posted

September 6, 2023

Study Start

August 18, 2023

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Seven years after the date of the last participant completing the study.
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.
More information

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