Behavior, Motor Activity, Overweight, Physical Activity
Conditions
Brief summary
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: 1. 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: 2. 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. 3. to assess participants' satisfaction with the overall program.
Interventions
Sponsors
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* women and men of all races/ethnicities living in Maricopa County, Arizona.
Exclusion criteria
* be between 18 and 60 years old * currently not exceeding physical activity recommendations determined by the International Physical Activity Questionnaire (IPAQ short form). * not have a medical condition based on the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) that requires supervised physical activity * not taking medication(s) that would prohibit a moderate intensity physical activity program * have a body mass index between 25 and 55 kg/m2 * not be currently pregnant or planning to become pregnant in the next 4 months * not be planning to leave Maricopa County for 10 days or more in the next 4 months * not planning to move from Maricopa County in the next 4 months * not currently in another physical activity, diet, or weight loss program (e.g. weight watchers) * have access to Microsoft Windows (XP, Vista, 7, 8) or Mac (10.5+) operating systems on computer with a USB port on a daily basis * have daily access to email and the internet * have a mobile phone with text messaging capabilities and be willing to send and receive up to 3-5 text messages per day.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fitbit-measured Steps/Day and Moderate-to-vigorous Physical Activity Between Study Arms. | Daily for 4 months | 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. |
Secondary
| Measure | 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Adaptive with Immediate Rewards | 25 |
| Arm 2 Adaptive with Delayed Rewards | 24 |
| Arm 3 Static with Immediate Rewards | 24 |
| Arm 4 Static with Delayed Non-Contingent Rewards | 23 |
| Total | 96 |
Baseline characteristics
| Characteristic | Arm 1 | Arm 2 | Arm 3 | Arm 4 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 41.0 years STANDARD_DEVIATION 10.16 | 44.5 years STANDARD_DEVIATION 10.7 | 38.4 years STANDARD_DEVIATION 8.22 | 40.3 years STANDARD_DEVIATION 7.91 | 41.0 years STANDARD_DEVIATION 9.46 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 4 Participants | 6 Participants | 3 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 20 Participants | 18 Participants | 20 Participants | 77 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 25 participants | 24 participants | 24 participants | 23 participants | 96 participants |
| Sex: Female, Male Female | 22 Participants | 17 Participants | 19 Participants | 16 Participants | 74 Participants |
| Sex: Female, Male Male | 3 Participants | 7 Participants | 5 Participants | 7 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 24 | 0 / 24 | 0 / 23 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 | 0 / 24 | 0 / 23 |
Outcome results
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.
Time frame: Daily for 4 months
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adaptive Goals | Change in Fitbit-measured Steps/Day and Moderate-to-vigorous Physical Activity Between Study Arms. | 9695 steps | Standard Deviation 3948 |
| Static Goals | Change in Fitbit-measured Steps/Day and Moderate-to-vigorous Physical Activity Between Study Arms. | 9836 steps | Standard Deviation 3930 |
| Immediate Reinforcement | Change in Fitbit-measured Steps/Day and Moderate-to-vigorous Physical Activity Between Study Arms. | 10562 steps | Standard Deviation 4032 |
| Delayed Non-contingent Reinforcement | Change in Fitbit-measured Steps/Day and Moderate-to-vigorous Physical Activity Between Study Arms. | 8969 steps | Standard Deviation 3802 |
Secondary
Change in Fitness (VO2max) Between Study Arms.
Time frame: Baseline and 4 months
Secondary
Changes in Body Mass Index and Body Composition Measured by Dual-energy X-Ray Absorptiometry (DEXA) Between Study Arms.
Time frame: Baseline and 4 months
Secondary
Changes to Cardiovascular-disease (CVD) Risk and Inflammatory Markers (e.g. Glucose, Insulin, Lipids, Adhesion Molecules and Hemostatic Factors) Between Groups.
Time frame: Baseline and 4 months
Secondary
Changes to iAortic Pulse Wave Velocity Assessed With the SphymocorTM Between Study Arms.
Time frame: Baseline and 4 months
Secondary
Changes to Self-reported Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ).
Time frame: Baseline and 4 months