Behavioral Economics for Activity Motivation in Adolescents (BEAM)

Study Overview
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Brief Summary
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There is an urgent need to engineer targeted physical activity interventions that are effective and scalable for obese adolescents and young adults (AYA) with type 2 diabetes (T2D), who often have very low levels of physical activity. The BEAM Trial is a proposed mobile health (mHealth) intervention that uses behavioral economic-informed financial incentives and text messaging to promote physical activity in AYA with T2D and prediabetes.

Official Title
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Behavioral Economics for Activity Motivation in Adolescents and Young Adults With Prediabetes and Type 2 Diabetes

Conditions
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Type 2 Diabetes, PreDiabetes, Insulin Resistance, Polycystic Ovary Syndrome

Intervention / Treatment
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* Behavioral: 1RLD
* Behavioral: 1RLW
* Behavioral: 1RGD
* Behavioral: 1RGW
* Behavioral: 2RLD
* Behavioral: 2RLW
* Behavioral: 2RGD
* Behavioral: 2RGW
* Behavioral: 1FLD
* Behavioral: 1FLW
* Behavioral: 1FGD
* Behavioral: 1FGW
* Behavioral: 2FLD
* Behavioral: 2FLW
* Behavioral: 2FGD
* Behavioral: 2FGW


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Males or females age 13 to 22 years. 2) Overweight or obese (BMI ≥85th percentile for age/sex, or ≥25 kg/m2 for participants ≥18 years) 3) Diagnosis with prediabetes or type 2 diabetes 4) Consent (subjects 18 and older), Parental/guardian permission (subjects 13-17), assent (subjects 13-17) 5) Willingness to wear Fitbit during waking hours daily for duration of run-in and intervention. 6) Possession of a smartphone. Exclusion Criteria: 1) Potential subject unable to speak or read in English 2) Severe cognitive impairment 3) Permanent or temporary physical disability that impairs ambulation or precludes engagement in MVPA 4) Current pregnancy 5) Previously-diagnosed or current restrictive or purging eating disorder 6) Moderate to vigorous physical activity (MVPA) >30 minutes per day or Fitbit wear < 4 days during second week of 2-week run-in period

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Condition 1<br>1RLD=One text per day, ramped goal, loss incentive, daily goal time period. | Behavioral: 1RLD<br>* 1RLD=One text per day, ramped goal, loss incentive, daily goal time period<br>|
| Experimental: Condition 2<br>1RLW=One text per day, ramped goal, loss incentive, weekly goal time period. | Behavioral: 1RLW<br>* 1RLW=One text per day, ramped goal, loss incentive, weekly goal time period.<br>|
| Experimental: Condition 3<br>1RGD=One text per day, ramped goal, gain incentive, daily goal time period. | Behavioral: 1RGD<br>* 1RGD=One text per day, ramped goal, gain incentive, daily goal time period.<br>|
| Experimental: Condition 4<br>1RGW=One text per day, ramped goal, gain incentive, weekly goal time period. | Behavioral: 1RGW<br>* One text per day, ramped goal, gain incentive, weekly goal time period.<br>|
| Experimental: Condition 5<br>2RLD=Two texts per day, ramped goal, loss incentive, daily goal time period. | Behavioral: 2RLD<br>* Two texts per day, ramped goal, loss incentive, daily goal time period.<br>|
| Experimental: Condition 6<br>2RLW=Two texts per day, ramped goal, loss incentive, weekly goal time period. | Behavioral: 2RLW<br>* Two texts per day, ramped goal, loss incentive, weekly goal time period.<br>|
| Experimental: Condition 7<br>2RGD=Two texts per day, ramped goal, gain incentive, daily goal time period. | Behavioral: 2RGD<br>* Two texts per day, ramped goal, gain incentive, daily goal time period.<br>|
| Experimental: Condition 8<br>2RGW=Two texts per day, ramped goal, gain incentive, weekly goal time period. | Behavioral: 2RGW<br>* Two texts per day, ramped goal, gain incentive, weekly goal time period.<br>|
| Experimental: Condition 9<br>1FLD=One text per day, fixed goal, loss incentive, daily goal time period. | Behavioral: 1FLD<br>* One text per day, fixed goal, loss incentive, daily weekly goal time period.<br>|
| Experimental: Condition 10<br>1FLW=One text per day, fixed goal, loss incentive, weekly goal time period. | Behavioral: 1FLW<br>* One text per day, fixed goal, loss incentive, weekly goal time period.<br>|
| Experimental: Condition 11<br>1FGD=One text per day, fixed goal, gain incentive, daily goal time period. | Behavioral: 1FGD<br>* One text per day, fixed goal, gain incentive, daily goal time period.<br>|
| Experimental: Condition 12<br>1FGW=One text per day, fixed goal, gain incentive, weekly goal time period. | Behavioral: 1FGW<br>* One text per day, fixed goal, gain incentive, weekly goal time period.<br>|
| Experimental: Condition 13<br>2FLD=Two texts per day, fixed goal, loss incentive, daily goal time period. | Behavioral: 2FLD<br>* Two texts per day, fixed goal, loss incentive, daily goal time period.<br>|
| Experimental: Condition 14<br>2FLW=Two texts per day, fixed goal, loss incentive, weekly goal time period. | Behavioral: 2FLW<br>* Two texts per day, fixed goal, loss incentive, weekly goal time period.<br>|
| Experimental: Condition 15<br>2FGD=Two texts per day, fixed goal, gain incentive, daily goal time period. | Behavioral: 2FGD<br>* Two texts per day, fixed goal, gain incentive, daily goal time period.<br>|
| Experimental: Condition 16<br>2FGW=Two texts per day, fixed goal, gain incentive, weekly goal time period. | Behavioral: 2FGW<br>* Two texts per day, fixed goal, gain incentive, weekly goal time period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate to Vigorous Physical Activity (MVPA) | Effects of time spent in MVPA will be measured by assessing the weekly mean minutes in MVPA per day | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Step Count | Daily step count will be measured by assessing the daily mean steps | 12 weeks |