NCT02717663

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
512

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

Enrollment Period

4.3 years

First QC Date

March 10, 2016

Last Update Submit

October 26, 2021

Conditions

Physical ActivityBehaviorGoals

Keywords

ReinforcementWalkingExerciseBuilt EnvironmentAdaptiveFinancial incentiveWalkability

Outcome Measures

Primary Outcomes (3)

  • Change in mean ActiGraph accelerometer-derived moderate-to-vigorous physical activity min/day (MVPA min/day) between study arms.

    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.

    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

    24 months

Secondary Outcomes (2)

  • Change in mean fitness (VO2max measured by treadmill test) between study arms.

    12 months

  • Change in self-reported physical activity measured by the International Physical Activity Questionnaire (IPAQ).

    12 months

Study Arms (4)

Static goals with delayed incentives

EXPERIMENTAL

Participants will receive static physical activity goals with delayed, non-contingent incentives

Behavioral: Static GoalsBehavioral: Delayed (non-contingent) Incentives

Adaptive goals with delayed incentives

EXPERIMENTAL

Participants will receive adaptive physical activity goals with delayed, non-contingent incentives

Behavioral: Adaptive GoalsBehavioral: Delayed (non-contingent) Incentives

Static goals with immediate rewards

EXPERIMENTAL

Participants will receive static physical activity goals with immediate rewards

Behavioral: Static GoalsBehavioral: Immediate Micro-Incentives

Adaptive goals with immediate rewards

EXPERIMENTAL

Participants will receive adaptive physical activity goals with immediate rewards

Behavioral: Adaptive GoalsBehavioral: Immediate Micro-Incentives

Interventions

Adaptive GoalsBEHAVIORAL

Prescribed goals change daily based on participant's performance

Adaptive goals with delayed incentivesAdaptive goals with immediate rewards
Static GoalsBEHAVIORAL

Prescribed goals remain the same throughout study

Static goals with delayed incentivesStatic goals with immediate rewards
Delayed (non-contingent) IncentivesBEHAVIORAL

Incentives are provided on bi-monthly basis for participation

Adaptive goals with delayed incentivesStatic goals with delayed incentives
Immediate Micro-IncentivesBEHAVIORAL

Incentives are provided immediately for each goal attained

Adaptive goals with immediate rewardsStatic goals with immediate rewards

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women and men of all races/ethnicities living in Maricopa County, Arizona

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Related Publications (3)

  • McEntee ML, Hurley JC, Phillips CB, Hooker SP, Todd M, Frank LD, Adams MA. The moderating impact of neighborhood walkability on mHealth interventions to increase moderate to vigorous physical activity for insufficiently active adults in a randomized trial. Int J Behav Nutr Phys Act. 2023 Aug 15;20(1):97. doi: 10.1186/s12966-023-01494-2.

    PMID: 37582736DERIVED

  • 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.

    PMID: 35000693DERIVED

  • 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.

    PMID: 33275107DERIVED

MeSH Terms

Conditions

Motor ActivityBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Exercise and Wellness Program, School of Nutrition and Health Promotion, College of Health Solutions.

Study Record Dates

First Submitted

March 10, 2016

First Posted

March 24, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

October 28, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)