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An Adaptive Physical Activity Intervention for Overweight Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01793064
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : January 15, 2014
Sponsor:
Collaborator:
Active Living Research
Information provided by (Responsible Party):
Marc Adams, Arizona State University

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:

  1. 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.
  2. 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.
  3. 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.

Condition or disease Intervention/treatment Phase
Physical Activity Behavioral: Adaptive Intervention (AI) Behavioral: Static Intervention (SI) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: An Adaptive Physical Activity Intervention for Overweight Adults: A Randomized Controlled Trial
Study Start Date : June 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adaptive Intervention Group (AI)
Adaptive Intervention Group (AI) receives adaptive step goals and feedback/incentives based on personal physical activity performance.
Behavioral: Adaptive Intervention (AI)
Adaptive Intervention Group (AI) receives adaptive step goals and feedback/incentives based on personal physical activity performance.

Active Comparator: Static Intervention group (SI)
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.
Behavioral: Static Intervention (SI)
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 Measures :
  1. Physical activity measured daily over 6 months by Omron pedometers (HJ-720ITC) . [ Time Frame: 6 months ]
    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 :
  1. Satisfaction Survey [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Live in San Diego County.
  2. Be between 18 and 55 years old.
  3. Currently not exceeding 1,000 MET-minutes per week of physical activity determined by the International Physical Activity Questionnaire (IPAQ short form).
  4. Not suffering from a medical condition or taking medication(s) that would prohibit one from adopting a moderate intensity physical activity program.
  5. Have a body mass index between 25 and 35 kg/m2.
  6. Not currently pregnant.
  7. Familiar with email and access to email and the internet daily,
  8. Not planning to leave San Diego County for more than 10 days over the next 6 months.
  9. Not planning to move away from San Diego County in the next 6 months.
  10. 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:

  1. Does not live in Dan Diego.
  2. Individuals under the age of 18 or over 55.
  3. Those who exceed 1,000 met-minutes of physical activity per week determined by the International Physical Activity Questionnaire (IPAQ short form).
  4. Suffering from a medical condition or taking medication which will prohibit one from adopting a moderate intensity physical activity program.
  5. Does not have a BMI between 25 and 35 kg/m2.
  6. Currently Pregnant.
  7. Unfamiliar with email, or does not have access to the internet and email daily.
  8. Planning to leave San Diego for more than ten days.
  9. Planning to move from San Diego in the next 6 months.
  10. Does not have access to Microsoft Windows or a Windows virtualization software for an Apple operating system.

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): NCT01793064


Locations
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United States, California
San Diego State University
San Diego, California, United States, 92182
Sponsors and Collaborators
Arizona State University
Active Living Research
Investigators
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Principal Investigator: Marc Adams, PhD Arizona State University

Publications of Results:
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Responsible Party: Marc Adams, Assistant Professor, Exercise and Wellness Program, School of Nutrition and Health Promotion, College of Health Solutions., Arizona State University
ClinicalTrials.gov Identifier: NCT01793064    
Other Study ID Numbers: AD-31475
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: January 15, 2014
Last Verified: January 2014
Keywords provided by Marc Adams, Arizona State University:
Pedometer,
adaptive,
exercise,
reinforcement,
goal setting,
technology,
email,
weight loss
mHealth
eHealth
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms