Behavioral Economics for Activity Motivation in Adolescents (BEAM)

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04874415
• Other study ID #: STUDY21040122
• Secondary ID: K23DK125719-01
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2021
• Est. completion date: April 1, 2025

Study information

• Verified date: April 2024
• Source: University of Pittsburgh
• Contact: Mary E Vajravelu, MD
• Phone: 412-692-6533
• Email: MaryEllen.Vajravelu[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: April 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Insulin Resistance
• Polycystic Ovary Syndrome
• PreDiabetes
• Prediabetic State
• Type 2 Diabetes

Intervention

Behavioral:
• 1RLD
1RLD=One text per day, ramped goal, loss incentive, daily goal time period
• 1RLW
1RLW=One text per day, ramped goal, loss incentive, weekly goal time period.
• 1RGD
1RGD=One text per day, ramped goal, gain incentive, daily goal time period.
• 1RGW
One text per day, ramped goal, gain incentive, weekly goal time period.
• 2RLD
Two texts per day, ramped goal, loss incentive, daily goal time period.
• 2RLW
Two texts per day, ramped goal, loss incentive, weekly goal time period.
• 2RGD
Two texts per day, ramped goal, gain incentive, daily goal time period.
• 2RGW
Two texts per day, ramped goal, gain incentive, weekly goal time period.
• 1FLD
One text per day, fixed goal, loss incentive, daily weekly goal time period.
• 1FLW
One text per day, fixed goal, loss incentive, weekly goal time period.
• 1FGD
One text per day, fixed goal, gain incentive, daily goal time period.
• 1FGW
One text per day, fixed goal, gain incentive, weekly goal time period.
• 2FLD
Two texts per day, fixed goal, loss incentive, daily goal time period.
• 2FLW
Two texts per day, fixed goal, loss incentive, weekly goal time period.
• 2FGD
Two texts per day, fixed goal, gain incentive, daily goal time period.
• 2FGW
Two texts per day, fixed goal, gain incentive, weekly goal time period.

Locations

Country	Name	City	State
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Daily Step Count	Daily step count will be measured by assessing the daily mean steps	12 weeks