An Adaptive Physical Activity Intervention for Overweight Adults
Primary Purpose
Physical Activity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adaptive Intervention (AI)
Static Intervention (SI)
Sponsored by
About this trial
This is an interventional prevention trial for Physical Activity focused on measuring Pedometer,, adaptive,, exercise,, reinforcement,, goal setting,, technology,, email,, weight loss, mHealth, eHealth
Eligibility Criteria
Inclusion Criteria:
- Live in San Diego County.
- Be between 18 and 55 years old.
- Currently not exceeding 1,000 MET-minutes per week of physical activity determined by the International Physical Activity Questionnaire (IPAQ short form).
- Not suffering from a medical condition or taking medication(s) that would prohibit one from adopting a moderate intensity physical activity program.
- Have a body mass index between 25 and 35 kg/m2.
- Not currently pregnant.
- Familiar with email and access to email and the internet daily,
- Not planning to leave San Diego County for more than 10 days over the next 6 months.
- Not planning to move away from San Diego County in the next 6 months.
- Potential participants must have access to Microsoft Windows (XP, Vista, or windows 7) on a daily basis. If they do not, they would need to have daily access to and use Windows virtualization software (e.g. Parallels, VMware) for an Apple operating system.
Exclusion Criteria:
- Does not live in Dan Diego.
- Individuals under the age of 18 or over 55.
- Those who exceed 1,000 met-minutes of physical activity per week determined by the International Physical Activity Questionnaire (IPAQ short form).
- Suffering from a medical condition or taking medication which will prohibit one from adopting a moderate intensity physical activity program.
- Does not have a BMI between 25 and 35 kg/m2.
- Currently Pregnant.
- Unfamiliar with email, or does not have access to the internet and email daily.
- Planning to leave San Diego for more than ten days.
- Planning to move from San Diego in the next 6 months.
- Does not have access to Microsoft Windows or a Windows virtualization software for an Apple operating system.
Sites / Locations
- San Diego State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Adaptive Intervention Group (AI)
Static Intervention group (SI)
Arm Description
Adaptive Intervention Group (AI) receives adaptive step goals and feedback/incentives based on personal physical activity performance.
Static Intervention group (SI) receives a static "usual care" goal of 10,000 steps/day and feedback/incentives for uploading their pedometer to the study website.
Outcomes
Primary Outcome Measures
Physical activity measured daily over 6 months by Omron pedometers (HJ-720ITC) .
Participants in both groups will be provided an Omron (HJ-720ITC) pedometer on the first day of the baseline phase, and will continue to use the pedometer throughout the entire study.
Secondary Outcome Measures
Satisfaction Survey
At the end of the intervention phase, participants completed a satisfaction interview to rate on Likert-type scales and open-ended questions how motivating or burdensome specific study components were to them, their overall satisfaction with the study, personal experience with the intervention, any side effects or injuries, and their recommendations for improvement.
Full Information
NCT ID
NCT01793064
First Posted
February 13, 2013
Last Updated
January 13, 2014
Sponsor
Arizona State University
Collaborators
Active Living Research
1. Study Identification
Unique Protocol Identification Number
NCT01793064
Brief Title
An Adaptive Physical Activity Intervention for Overweight Adults
Official Title
An Adaptive Physical Activity Intervention for Overweight Adults: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University
Collaborators
Active Living Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to develop and evaluate an adaptive shaping intervention based on Behavioral Economics and Operant principles to promote physical activity behaviors (adaptive group) and compare to a static physical activity intervention (static group) using a two-group randomized controlled trial design. Participants will include 20 overweight men and women (BMI 25-35 kg/m2) between 18 to 55 years. Both groups will receive the following components: 1) a pedometer, 2) self-monitoring of physical activity, 3) brief educational materials, 4) motivational prompts, 5) physical activity goals, and 6) small financial incentives. The Adaptive Intervention (AI) group will receive adaptive goals and feedback based on percentiles and a "moving" window of their recent physical activity, with incentives linked to goal attainment. Comparison intervention participants will receive the static 10,000 steps per day goal, with matching incentive amounts but without incentives linked to goal attainment. The study will compare differences in goal setting and shaping procedures that aim to increase physical activity behavior.
Primary aims include:
To determine whether physical activity (pedometer-measured steps/day) in both the Adaptive and Static interventions increased compared to their respective baselines. Hypothesis: Both the adaptive and static interventions will result in increased physical activity over 6 months.
To evaluate whether the Adaptive Intervention results in greater change in physical activity (pedometer-measured steps/day) compared to the Static Intervention. Hypothesis: The adaptive intervention will result in significantly greater physical activity, measured by pedometer, compared to the static intervention over 6 months.
To assess participants' satisfaction with the overall program. Hypothesis: Adaptive Intervention participants will report greater overall satisfaction with the intervention than the Static Intervention participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity
Keywords
Pedometer,, adaptive,, exercise,, reinforcement,, goal setting,, technology,, email,, weight loss, mHealth, eHealth
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adaptive Intervention Group (AI)
Arm Type
Experimental
Arm Description
Adaptive Intervention Group (AI) receives adaptive step goals and feedback/incentives based on personal physical activity performance.
Arm Title
Static Intervention group (SI)
Arm Type
Active Comparator
Arm Description
Static Intervention group (SI) receives a static "usual care" goal of 10,000 steps/day and feedback/incentives for uploading their pedometer to the study website.
Intervention Type
Behavioral
Intervention Name(s)
Adaptive Intervention (AI)
Intervention Description
Adaptive Intervention Group (AI) receives adaptive step goals and feedback/incentives based on personal physical activity performance.
Intervention Type
Behavioral
Intervention Name(s)
Static Intervention (SI)
Intervention Description
Static Intervention group (SI) receives a static "usual care" goal of 10,000 steps/day and feedback/incentives for uploading their pedometer to the study website.
Primary Outcome Measure Information:
Title
Physical activity measured daily over 6 months by Omron pedometers (HJ-720ITC) .
Description
Participants in both groups will be provided an Omron (HJ-720ITC) pedometer on the first day of the baseline phase, and will continue to use the pedometer throughout the entire study.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Satisfaction Survey
Description
At the end of the intervention phase, participants completed a satisfaction interview to rate on Likert-type scales and open-ended questions how motivating or burdensome specific study components were to them, their overall satisfaction with the study, personal experience with the intervention, any side effects or injuries, and their recommendations for improvement.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Live in San Diego County.
Be between 18 and 55 years old.
Currently not exceeding 1,000 MET-minutes per week of physical activity determined by the International Physical Activity Questionnaire (IPAQ short form).
Not suffering from a medical condition or taking medication(s) that would prohibit one from adopting a moderate intensity physical activity program.
Have a body mass index between 25 and 35 kg/m2.
Not currently pregnant.
Familiar with email and access to email and the internet daily,
Not planning to leave San Diego County for more than 10 days over the next 6 months.
Not planning to move away from San Diego County in the next 6 months.
Potential participants must have access to Microsoft Windows (XP, Vista, or windows 7) on a daily basis. If they do not, they would need to have daily access to and use Windows virtualization software (e.g. Parallels, VMware) for an Apple operating system.
Exclusion Criteria:
Does not live in Dan Diego.
Individuals under the age of 18 or over 55.
Those who exceed 1,000 met-minutes of physical activity per week determined by the International Physical Activity Questionnaire (IPAQ short form).
Suffering from a medical condition or taking medication which will prohibit one from adopting a moderate intensity physical activity program.
Does not have a BMI between 25 and 35 kg/m2.
Currently Pregnant.
Unfamiliar with email, or does not have access to the internet and email daily.
Planning to leave San Diego for more than ten days.
Planning to move from San Diego in the next 6 months.
Does not have access to Microsoft Windows or a Windows virtualization software for an Apple operating system.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Adams, PhD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Diego State University
City
San Diego
State/Province
California
ZIP/Postal Code
92182
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24349392
Citation
Adams MA, Sallis JF, Norman GJ, Hovell MF, Hekler EB, Perata E. An adaptive physical activity intervention for overweight adults: a randomized controlled trial. PLoS One. 2013 Dec 9;8(12):e82901. doi: 10.1371/journal.pone.0082901. eCollection 2013.
Results Reference
result
Learn more about this trial
An Adaptive Physical Activity Intervention for Overweight Adults
We'll reach out to this number within 24 hrs