Physical ActivityWalkITNCT02053259
A Walking Intervention Through Text Messaging
A study testing Adaptive Goals, Reinforcement and Static Goals in people with Physical Activity and Behavior, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Behavior, Overweight
- What is being tested?
- Adaptive Goals, Reinforcement and Static Goals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- women and men of all races/ethnicities living in Maricopa County, Arizona.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona State Univertsity, School of Nutrition and Health Promotion
Phoenix, Arizona, 85004
About this study
Official title: 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.
- Conditions
- Physical Activity, Behavior, Overweight, Motor Activity
- Being tested
- Adaptive Goals, Reinforcement, Static Goals
- Medical subject headings
- Motor Activity, Behavior, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive GoalsBehavioural
ReinforcementBehavioural
Static GoalsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Goals with Immediate Reinforcement | Experimental | Adaptive Physical Activity Goals, Immediate Financial Reinforcement Receives: Behavioral: Adaptive Goals; Behavioral: Reinforcement |
| Adaptive Goals with Delayed Reinforcement | Experimental | Adaptive Physical Activity Goals, Delayed Financial Reinforcement Receives: Behavioral: Adaptive Goals |
| Static Goals with Immediate Reinforcement | Experimental | Static Physical Activity Goals, Immediate Financial Reinforcement Receives: Behavioral: Reinforcement; Behavioral: Static Goals |
| Static Goals with Delayed Reinforcement | Active comparator | Static Physical Activity Goals, Delayed Financial Reinforcement Receives: Behavioral: Static Goals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fitbit-measured Steps/Day and Moderate-to-vigorous Physical Activity Between Study Arms.
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.
Measured: Daily for 4 months
Secondary outcomes (5)
Change in Fitness (VO2max) Between Study Arms.
Measured: Baseline and 4 months
Changes in Body Mass Index and Body Composition Measured by Dual-energy X-Ray Absorptiometry (DEXA) Between Study Arms.
Measured: Baseline and 4 months
Changes to iAortic Pulse Wave Velocity Assessed With the SphymocorTM Between Study Arms.
Measured: Baseline and 4 months
Changes to Cardiovascular-disease (CVD) Risk and Inflammatory Markers (e.g. Glucose, Insulin, Lipids, Adhesion Molecules and Hemostatic Factors) Between Groups.
Measured: Baseline and 4 months
Changes to Self-reported Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ).
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Adams, PhD, MPH, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053259
- Sponsor's protocol ID
- ASU-SNHP01
- Acronym
- WalkIT
- Status last verified
- Aug 2021
- First submitted
- 31 Jan 2014
- Last updated
- 22 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 26362511Adams 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.
PubMed 28356097Phillips 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.
PubMed 30973315
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking Intervention Through Texting Study: A Factorial Trial
- ClinicalTrials.gov ID
- NCT02053259
- Acronym / sponsor ID
- WalkIT / ASU-SNHP01
- Conditions
- Physical Activity, Behavior, Overweight, Motor Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Posted 29 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adaptive Goals with Immediate Reinforcement | Experimental | Behavioral: Adaptive Goals, Behavioral: ReinforcementAdaptive Physical Activity Goals, Immediate Financial Reinforcement |
| Adaptive Goals with Delayed Reinforcement | Experimental | Behavioral: Adaptive GoalsAdaptive Physical Activity Goals, Delayed Financial Reinforcement |
| Static Goals with Immediate Reinforcement | Experimental | Behavioral: Reinforcement, Behavioral: Static GoalsStatic Physical Activity Goals, Immediate Financial Reinforcement |
| Static Goals with Delayed Reinforcement | Active comparator | Behavioral: Static GoalsStatic Physical Activity Goals, Delayed Financial Reinforcement |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women and men of all races/ethnicities living in Maricopa County, Arizona.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive Goals | Behavioural | Adaptive Goals with Delayed Reinforcement, Adaptive Goals with Immediate Reinforcement |
| Reinforcement | Behavioural | Adaptive Goals with Immediate Reinforcement, Static Goals with Immediate Reinforcement |
| Static Goals | Behavioural | Static Goals with Delayed Reinforcement, Static Goals with Immediate Reinforcement |
Primary outcome
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.
5 secondary outcomes
Change in Fitness (VO2max) Between Study Arms.
Time frame: Baseline and 4 months
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
Changes to iAortic Pulse Wave Velocity Assessed With the SphymocorTM Between Study Arms.
Time frame: Baseline and 4 months
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
Changes to Self-reported Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ).
Time frame: Baseline and 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26362511Hurley 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.
- Results publication: PubMed 28356097Adams 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.
- Results publication: PubMed 30973315Phillips 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Goals, Reinforcement and Static Goals in people with Physical Activity and Behavior, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fitbit-measured Steps/Day and Moderate-to-vigorous Physical Activity Between Study Arms. (time frame: Daily for 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02053259, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.