Physical ActivityNCT01793064
An Adaptive Physical Activity Intervention for Overweight Adults
A study testing Adaptive Intervention (AI) and Static Intervention (SI) in people with Physical Activity, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Adaptive Intervention (AI) and Static Intervention (SI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University
San Diego, California, 92182
About this study
Official title: An Adaptive Physical Activity Intervention for Overweight Adults: A Randomized Controlled Trial
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.
- Conditions
- Physical Activity
- Being tested
- Adaptive Intervention (AI), Static Intervention (SI)
- Keywords
- Pedometer,, adaptive,, exercise,, reinforcement,, goal setting,, technology,, email,, weight loss, mHealth, eHealth
- Medical subject headings
- Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Intervention (AI)Behavioural
Adaptive Intervention Group (AI) receives adaptive step goals and feedback/incentives based on personal physical activity performance.
Static Intervention (SI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Intervention Group (AI) | Experimental | Adaptive Intervention Group (AI) receives adaptive step goals and feedback/incentives based on personal physical activity performance. Receives: Behavioral: Adaptive Intervention (AI) |
| Static Intervention group (SI) | Active comparator | 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. Receives: Behavioral: Static Intervention (SI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startJun 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Active Living Research
- Responsible party
- Principal investigator, Marc Adams, Arizona State University
- Investigators
- Marc Adams, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793064
- Sponsor's protocol ID
- AD-31475
- Status last verified
- Jan 2014
- First submitted
- 13 Feb 2013
- Last updated
- 15 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24349392
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Physical Activity Intervention for Overweight Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01793064
- Acronym / sponsor ID
- AD-31475
- Conditions
- Physical Activity
- Keywords
- Pedometer,, adaptive,, exercise,, reinforcement,, goal setting,, technology,, email,, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Active Living Research
- Study start
- Jun 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive Intervention Group (AI) | Experimental | Behavioral: Adaptive Intervention (AI)Adaptive Intervention Group (AI) receives adaptive step goals and feedback/incentives based on personal physical activity performance. |
| Static Intervention group (SI) | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 Intervention (AI)Adaptive Intervention Group (AI) receives adaptive step goals and feedback/incentives based on personal physical activity performance. | Behavioural | Adaptive Intervention Group (AI) |
| 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. | Behavioural | Static Intervention group (SI) |
Primary outcome
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.
1 secondary outcome
Satisfaction Survey
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
- Results publication: PubMed 24349392Adams 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.
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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.
Marc Adams, PhD principal investigator
Arizona State University
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 Intervention (AI) and Static Intervention (SI) in people with Physical Activity, 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 10 inclusion and 10 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 15 Jan 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physical activity measured daily over 6 months by Omron pedometers (HJ-720ITC) . (time frame: 6 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 NCT01793064, which also lists 1 linked publication.
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 15 Jan 2014; AzTrials last refreshed its copy on 30 Oct 2026.