- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02053259
A Walking Intervention Through Text Messaging (WalkIT)
Walking Intervention Through Texting Study: A Factorial Trial
The purpose of this study is to develop and evaluate adaptive goal setting and feedback interventions (Adaptive Interventions) to promote physical activity behaviors and compare it to static physical activity interventions (Static Interventions) using two levels of goal setting (Adaptive Goals vs. Static Goals) and two levels of reinforcement procedures (Praise/Rewards and No Praise/Rewards) in a 2 x 2 factorial randomized controlled trial. All four groups will receive the intervention via a semi-automated text message system developed by the investigators study team.
The primary aim of this study will be to:
Evaluate whether the adaptive interventions result in greater change in physical activity (pedometer-measured steps/day) compared to the static Intervention groups. HYPOTHESES: Participants in the adaptive interventions will increase their steps/day more than participants in the Static Intervention groups. The Adaptive Goals and Reinforcement Group will outperform the other 3 groups.
The secondary aims of this study will be to:
- Evaluate the effectiveness of the adaptive and static goal interventions in improving anthropometric, cardiovascular fitness, and cardiometabolic risk factors. HYPOTHESES: Participants in the adaptive interventions will show greater improvements in fitness, lean and fat body mass, and serum biomarkers than participants in the Static Intervention groups. The Adaptive Goals and Reinforcement Group will outperform the other 3 groups.
- to assess participants' satisfaction with the overall program.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
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Phoenix, Arizona, United States, 85004
- Arizona State Univertsity, School of Nutrition and Health Promotion
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- women and men of all races/ethnicities living in Maricopa County, Arizona.
Exclusion Criteria:
- be between 18 and 60 years old
- currently not exceeding physical activity recommendations determined by the International Physical Activity Questionnaire (IPAQ short form).
- not have a medical condition based on the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) that requires supervised physical activity
- not taking medication(s) that would prohibit a moderate intensity physical activity program
- have a body mass index between 25 and 55 kg/m2
- not be currently pregnant or planning to become pregnant in the next 4 months
- not be planning to leave Maricopa County for 10 days or more in the next 4 months
- not planning to move from Maricopa County in the next 4 months
- not currently in another physical activity, diet, or weight loss program (e.g. weight watchers)
- have access to Microsoft Windows (XP, Vista, 7, 8) or Mac (10.5+) operating systems on computer with a USB port on a daily basis
- have daily access to email and the internet
- have a mobile phone with text messaging capabilities and be willing to send and receive up to 3-5 text messages per day.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adaptive Goals with Immediate Reinforcement
Adaptive Physical Activity Goals, Immediate Financial Reinforcement
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Experimental: Adaptive Goals with Delayed Reinforcement
Adaptive Physical Activity Goals, Delayed Financial Reinforcement
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Experimental: Static Goals with Immediate Reinforcement
Static Physical Activity Goals, Immediate Financial Reinforcement
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Active Comparator: Static Goals with Delayed Reinforcement
Static Physical Activity Goals, Delayed Financial Reinforcement
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Fitbit-measured Steps/Day and Moderate-to-vigorous Physical Activity Between Study Arms.
Time Frame: Daily for 4 months
|
Given this study used a 2 condition (adaptive vs. static goals) x 2 condition (immediate vs. delayed financial reinforcement) randomized factorial design we report main effects for each condition.
Sample sizes for main effects will be 96 participants for each comparison (Adaptive vs. Static goals or Immediate vs. Delayed Reinforcement) as the other condition.
Consistent with proper analyses of factorial designs, main effects for the goal setting conditions pool participants across reinforcement conditions, and main effects for reinforcement conditions pool participants across goal setting conditions.
|
Daily for 4 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Fitness (VO2max) Between Study Arms.
Time Frame: Baseline and 4 months
|
Baseline and 4 months
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Changes in Body Mass Index and Body Composition Measured by Dual-energy X-Ray Absorptiometry (DEXA) Between Study Arms.
Time Frame: Baseline and 4 months
|
Baseline and 4 months
|
Changes to iAortic Pulse Wave Velocity Assessed With the SphymocorTM Between Study Arms.
Time Frame: Baseline and 4 months
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Baseline and 4 months
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Changes to Cardiovascular-disease (CVD) Risk and Inflammatory Markers (e.g. Glucose, Insulin, Lipids, Adhesion Molecules and Hemostatic Factors) Between Groups.
Time Frame: Baseline and 4 months
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Baseline and 4 months
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Changes to Self-reported Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ).
Time Frame: Baseline and 4 months
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Baseline and 4 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Hurley JC, Hollingshead KE, Todd M, Jarrett CL, Tucker WJ, Angadi SS, Adams MA. The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults. JMIR Res Protoc. 2015 Sep 11;4(3):e108. doi: 10.2196/resprot.4856.
- Adams MA, Hurley JC, Todd M, Bhuiyan N, Jarrett CL, Tucker WJ, Hollingshead KE, Angadi SS. Adaptive goal setting and financial incentives: a 2 x 2 factorial randomized controlled trial to increase adults' physical activity. BMC Public Health. 2017 Mar 29;17(1):286. doi: 10.1186/s12889-017-4197-8. Erratum In: BMC Public Health. 2017 Apr 6;17 (1):303.
- Phillips CB, Hurley JC, Angadi SS, Todd M, Berardi V, Hovell MF, Adams MA. Delay Discount Rate Moderates a Physical Activity Intervention Testing Immediate Rewards. Behav Med. 2020 Apr-Jun;46(2):142-152. doi: 10.1080/08964289.2019.1570071. Epub 2019 Apr 11.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASU-SNHP01
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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