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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adaptive Goals with Immediate Reinforcement | Experimental | Adaptive Physical Activity Goals, Immediate Financial Reinforcement |
|
| Adaptive Goals with Delayed Reinforcement | Experimental | Adaptive Physical Activity Goals, Delayed Financial Reinforcement |
|
| Static Goals with Immediate Reinforcement | Experimental | Static Physical Activity Goals, Immediate Financial Reinforcement |
|
| Static Goals with Delayed Reinforcement | Active Comparator | Static Physical Activity Goals, Delayed Financial Reinforcement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive Goals | Behavioral |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Daily for 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fitness (VO2max) Between Study Arms. | Baseline and 4 months | |
| Changes in Body Mass Index and Body Composition Measured by Dual-energy X-Ray Absorptiometry (DEXA) Between Study Arms. | Baseline and 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State Univertsity, School of Nutrition and Health Promotion | Phoenix | Arizona | 85004 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26362511 | Background | 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. | |
| 28356097 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adaptive Physical Activity Goals With Immediate Reinforcement | Adaptive Physical Activity Goals with Immediate Reinforcement |
| FG001 | Adaptive Physical Activity Goals With Delayed Reinforcement | Adaptive Physical Activity Goals with Delayed Reinforcement |
| FG002 | Static Physical Activity Goals With Immediate Reinforcement | Static Physical Activity Goals with Immediate Reinforcement |
| FG003 | Static Physical Activity Goals With Delayed Reinforcement | Static Physical Activity Goals with Delayed Reinforcement |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Adaptive with Immediate Rewards |
| BG001 | Arm 2 | Adaptive with Delayed Rewards |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 2x2 factorial design main effects reported. Main effects for goal setting (n=49 for adaptive vs. n=47 for static) and reinforcement conditions (n=49 for immediate reinforcement vs. n=47 for delayed, non-contingent reinforcement). | Posted | Mean | Standard Deviation | steps | Daily for 4 months |
|
Continuously over the course of the 4-month intervention period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Adaptive Goals, Reinforcement Adaptive Goals Reinforcement |
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Not all of the secondary outcome data have been analyzed and some results are pending review by a journal.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marc Adams | Arizona State University | 602-827-2470 | marc.adams@asu.edu |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D001519 | Behavior |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000098408 | Reinforcement Machine Learning |
| ID | Term |
|---|---|
| D000069550 | Machine Learning |
| D001185 | Artificial Intelligence |
| D000465 | Algorithms |
| D055641 | Mathematical Concepts |
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| Reinforcement |
| Behavioral |
|
| Static Goals | Behavioral |
|
| Changes to iAortic Pulse Wave Velocity Assessed With the SphymocorTM Between Study Arms. | 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. | Baseline and 4 months |
| Changes to Self-reported Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ). | Baseline and 4 months |
| Adams 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. |
| 30973315 | Result | Phillips 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. |
| BG002 |
| Arm 3 |
Static with Immediate Rewards |
| BG003 | Arm 4 | Static with Delayed Non-Contingent Rewards |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Adaptive Goals |
Adaptive goals |
| OG001 | Static Goals | Static goals |
| OG002 | Immediate Reinforcement | Immediate reinforcement |
| OG003 | Delayed Non-contingent Reinforcement | Delayed non-contingent reinforcement |
|
|
| Secondary | Change in Fitness (VO2max) Between Study Arms. | Not Posted | Jan 2023 | Baseline and 4 months | Participants |
| Secondary | Changes in Body Mass Index and Body Composition Measured by Dual-energy X-Ray Absorptiometry (DEXA) Between Study Arms. | Not Posted | Jan 2023 | Baseline and 4 months | Participants |
| Secondary | Changes to iAortic Pulse Wave Velocity Assessed With the SphymocorTM Between Study Arms. | Not Posted | Jan 2023 | Baseline and 4 months | Participants |
| Secondary | Changes to Cardiovascular-disease (CVD) Risk and Inflammatory Markers (e.g. Glucose, Insulin, Lipids, Adhesion Molecules and Hemostatic Factors) Between Groups. | Not Posted | Jan 2023 | Baseline and 4 months | Participants |
| Secondary | Changes to Self-reported Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ). | Not Posted | Jan 2023 | Baseline and 4 months | Participants |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Arm 2 | Adaptive Goals, No Reinforcement Adaptive Goals | 0 | 24 | 0 | 24 |
| EG002 | Arm 3 | Static Goals, Reinforcement Reinforcement Static Goals | 0 | 24 | 0 | 24 |
| EG003 | Arm 4 | Static Goals, No reinforcement Static Goals | 0 | 23 | 0 | 23 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |