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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02717663
Other study ID # R01CA198915
Secondary ID R01CA198915
Status Completed
Phase N/A
First received
Last updated
Start date May 2016
Est. completion date August 2020

Study information

Verified date October 2021
Source Arizona State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 512
Est. completion date August 2020
Est. primary completion date August 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Adaptive Goals
Prescribed goals change daily based on participant's performance
Static Goals
Prescribed goals remain the same throughout study
Delayed (non-contingent) Incentives
Incentives are provided on bi-monthly basis for participation
Immediate Micro-Incentives
Incentives are provided immediately for each goal attained

Locations

Country Name City State
United States Arizona State University Phoenix Arizona

Sponsors (2)

Lead Sponsor Collaborator
Arizona State University National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in mean ActiGraph accelerometer-derived moderate-to-vigorous physical activity min/day (MVPA min/day) between study arms. 12 months
Primary 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. 12 months
Primary 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 24 months
Secondary Change in mean fitness (VO2max measured by treadmill test) between study arms. 12 months
Secondary Change in self-reported physical activity measured by the International Physical Activity Questionnaire (IPAQ). 12 months
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