Behavioral Economics for Activity Motivation in Adolescents (BEAM)

Not Applicable

Completed

• Conditions: Insulin Resistance; PreDiabetes; Polycystic Ovary Syndrome; Type 2 Diabetes
• Interventions: Behavioral: 2RLW; Behavioral: 2RGW; Behavioral: 1FLD; Behavioral: 2FLW; Behavioral: 1RLD; Behavioral: 1FLW; Behavioral: 2FLD; Behavioral: 2FGW; Behavioral: 1RGD; Behavioral: 1RGW; Behavioral: 2RLD; Behavioral: 2RGD; Behavioral: 1RLW; Behavioral: 1FGD; Behavioral: 2FGD; Behavioral: 1FGW

• Registration Number: NCT04874415
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-30
• Study First Submitted QC: 2021-04-30
• Study First Posted: 2021-05-05
• Study Start: 2021-11-16
• Primary Completion: 2024-10-04
• Study Completion: 2024-10-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Condition 6	2RLW	2RLW=Two texts per day, ramped goal, loss incentive, weekly goal time period.
Condition 8	2RGW	2RGW=Two texts per day, ramped goal, gain incentive, weekly goal time period.
Condition 9	1FLD	1FLD=One text per day, fixed goal, loss incentive, daily goal time period.
Condition 14	2FLW	2FLW=Two texts per day, fixed goal, loss incentive, weekly goal time period.
Condition 1	1RLD	1RLD=One text per day, ramped goal, loss incentive, daily goal time period.
Condition 10	1FLW	1FLW=One text per day, fixed goal, loss incentive, weekly goal time period.
Condition 13	2FLD	2FLD=Two texts per day, fixed goal, loss incentive, daily goal time period.
Condition 16	2FGW	2FGW=Two texts per day, fixed goal, gain incentive, weekly goal time period.
Condition 3	1RGD	1RGD=One text per day, ramped goal, gain incentive, daily goal time period.
Condition 4	1RGW	1RGW=One text per day, ramped goal, gain incentive, weekly goal time period.
Condition 5	2RLD	2RLD=Two texts per day, ramped goal, loss incentive, daily goal time period.
Condition 7	2RGD	2RGD=Two texts per day, ramped goal, gain incentive, daily goal time period.
Condition 2	1RLW	1RLW=One text per day, ramped goal, loss incentive, weekly goal time period.
Condition 11	1FGD	1FGD=One text per day, fixed goal, gain incentive, daily goal time period.
Condition 15	2FGD	2FGD=Two texts per day, fixed goal, gain incentive, daily goal time period.
Condition 12	1FGW	1FGW=One text per day, fixed goal, gain incentive, weekly goal time period.

Primary Outcome Measures

Name	Time	Method
Moderate to Vigorous Physical Activity (MVPA)	12 weeks	Effects of time spent in MVPA will be measured by assessing the weekly mean minutes in MVPA per day

Secondary Outcome Measures

Name	Time	Method
Daily Step Count	12 weeks	Daily step count will be measured by assessing the daily mean steps

Trial Locations

Locations (1)

UPMC Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States