- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02717663
WalkIT Arizona: Walking Interventions Through Texting
October 26, 2021 updated by: Marc Adams, PhD, MPH, Arizona State University
WalkIT: Neighborhood Walkability and Moderation of Adaptive Walking Interventions
The purpose of this study is to develop adaptive (AI) and micro-incentive (MI) interventions and test them against static (SI) and delayed-incentive (DI) interventions in a 4-arm randomized factorial trial to increase MVPA adoption and maintenance among inactive adults.
Using neighborhood walkability and socioeconomic status, participants will be recruited from four neighborhood types: "high walkable/high SES," "high walkable/low SES," "low walkable/high SES," and "low walkable/low SES."
We will evaluate synergistic or antagonistic effects of interventions and neighborhood factors on MVPA adoption by 12 months and maintenance by 24 months.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
512
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arizona
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Phoenix, Arizona, United States, 85004
- Arizona State University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- women and men of all races/ethnicities living in Maricopa County, Arizona
Exclusion Criteria:
- Live in one of the eligible neighborhood quadrants in Maricopa County, Arizona
- Adult men and women between 18 and 60 years old
- Inactive as screened by the International Physical Activity Questionnaire (IPAQ) short form and confirmed by baseline accelerometer measures
- No history of heart failure or type 2 diabetes
- No contraindications to exercise testing or requirement for medically supervised exercise (assessed by Physical Activity Readiness Questionnaire+ (PAR-Q+).
- Not currently pregnant and not planning to becoming pregnant in the next 2 years
- Not currently participating in physical activity, diet, or weight loss programs
- Daily access to a mobile phone with text messaging capabilities or an iOS or Android smartphone
- Willing to wear a small accelerometer on the wrist daily for 1 year
- Willing to send and receive 2-3 text messages per day for 1 year
- Not planning to be outside of Maricopa County for > 30 days consecutively in the next 2 years
- Not planning to move from their current home in the next 2 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Static goals with delayed incentives
Participants will receive static physical activity goals with delayed, non-contingent incentives
|
Prescribed goals remain the same throughout study
Incentives are provided on bi-monthly basis for participation
|
Experimental: Adaptive goals with delayed incentives
Participants will receive adaptive physical activity goals with delayed, non-contingent incentives
|
Incentives are provided on bi-monthly basis for participation
Prescribed goals change daily based on participant's performance
|
Experimental: Static goals with immediate rewards
Participants will receive static physical activity goals with immediate rewards
|
Prescribed goals remain the same throughout study
Incentives are provided immediately for each goal attained
|
Experimental: Adaptive goals with immediate rewards
Participants will receive adaptive physical activity goals with immediate rewards
|
Prescribed goals change daily based on participant's performance
Incentives are provided immediately for each goal attained
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in mean ActiGraph accelerometer-derived moderate-to-vigorous physical activity min/day (MVPA min/day) between study arms.
Time Frame: 12 months
|
12 months
|
Change in mean ActiGraph accelerometer-derived moderate-to-vigorous physical activity min/day (MVPA min/day) across high walkable (vs. low walkable) neighborhoods by 12 months.
Time Frame: 12 months
|
12 months
|
Change in mean ActiGraph accelerometer-derived moderate-to-vigorous physical activity min/day (MVPA min/day) across high walkable (vs. low walkable) neighborhoods by 24 months
Time Frame: 24 months
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24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in mean fitness (VO2max measured by treadmill test) between study arms.
Time Frame: 12 months
|
12 months
|
Change in self-reported physical activity measured by the International Physical Activity Questionnaire (IPAQ).
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Adams MA, Todd M, Angadi SS, Hurley JC, Stecher C, Berardi V, Phillips CB, McEntee ML, Hovell MF, Hooker SP. Adaptive Goals and Reinforcement Timing to Increase Physical Activity in Adults: A Factorial Randomized Trial. Am J Prev Med. 2022 Feb;62(2):e57-e68. doi: 10.1016/j.amepre.2021.09.014. Epub 2021 Dec 8.
- McEntee ML, Cantley A, Foreman E, Berardi V, Phillips CB, Hurley JC, Hovell MF, Hooker S, Adams MA. Effects of Goal Type and Reinforcement Type on Self-Reported Domain-Specific Walking Among Inactive Adults: 2x2 Factorial Randomized Controlled Trial. JMIR Form Res. 2020 Dec 4;4(12):e19863. doi: 10.2196/19863.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2016
Primary Completion (Actual)
August 1, 2020
Study Completion (Actual)
August 1, 2020
Study Registration Dates
First Submitted
March 10, 2016
First Submitted That Met QC Criteria
March 18, 2016
First Posted (Estimate)
March 24, 2016
Study Record Updates
Last Update Posted (Actual)
October 28, 2021
Last Update Submitted That Met QC Criteria
October 26, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- R01CA198915 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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