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Completed

NCT Number: NCT01793064

An Adaptive Physical Activity Intervention for Overweight Adults

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.

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Key information

Conditions

Physical Activity Behavior Body Weight Body Weight Changes Motor Activity Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Diego State University

San Diego, California, 92182, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adaptive Intervention (AI)

Behavioral

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

Static Intervention (SI)

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • Active Living Research

Registry information

Official study title

An Adaptive Physical Activity Intervention for Overweight Adults: A Randomized Controlled Trial

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 15, 2013
Registry last updated
Jan 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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