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A Walking Intervention Through Text Messaging (WalkIT)

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ClinicalTrials.gov Identifier: NCT02053259
Recruitment Status : Completed
First Posted : February 3, 2014
Results First Posted : July 29, 2020
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Marc Adams, PhD, MPH, Arizona State University

Brief Summary:

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:

  1. 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:

  2. 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.
  3. to assess participants' satisfaction with the overall program.

Condition or disease Intervention/treatment Phase
Physical Activity Behavior Overweight Motor Activity Behavioral: Adaptive Goals Behavioral: Reinforcement Behavioral: Static Goals Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Walking Intervention Through Texting Study: A Factorial Trial
Actual Study Start Date : February 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Adaptive Goals with Immediate Reinforcement
Adaptive Physical Activity Goals, Immediate Financial Reinforcement
Behavioral: Adaptive Goals
Behavioral: Reinforcement
Experimental: Adaptive Goals with Delayed Reinforcement
Adaptive Physical Activity Goals, Delayed Financial Reinforcement
Behavioral: Adaptive Goals
Experimental: Static Goals with Immediate Reinforcement
Static Physical Activity Goals, Immediate Financial Reinforcement
Behavioral: Reinforcement
Behavioral: Static Goals
Active Comparator: Static Goals with Delayed Reinforcement
Static Physical Activity Goals, Delayed Financial Reinforcement
Behavioral: Static Goals



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Fitness (VO2max) Between Study Arms. [ Time Frame: Baseline and 4 months ]
  2. 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 ]
  3. Changes to iAortic Pulse Wave Velocity Assessed With the SphymocorTM Between Study Arms. [ Time Frame: Baseline and 4 months ]
  4. 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 ]
  5. Changes to Self-reported Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ). [ Time Frame: Baseline and 4 months ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02053259


Locations
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United States, Arizona
Arizona State Univertsity, School of Nutrition and Health Promotion
Phoenix, Arizona, United States, 85004
Sponsors and Collaborators
Arizona State University
Publications of Results:
Other Publications:
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Responsible Party: Marc Adams, PhD, MPH, Associate Professor, College of Health Solutions, Arizona State University
ClinicalTrials.gov Identifier: NCT02053259    
Other Study ID Numbers: ASU-SNHP01
First Posted: February 3, 2014    Key Record Dates
Results First Posted: July 29, 2020
Last Update Posted: July 29, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Overweight
Body Weight