Behavioral Economics for Activity Motivation in Adolescents (BEAM)

April 3, 2024 updated by: Mary Ellen Vajravelu, MD, University of Pittsburgh

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • UPMC Children's Hospital of Pittsburgh
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Moderate to Vigorous Physical Activity (MVPA)
Time Frame: 12 weeks
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
Time Frame: 12 weeks
Daily step count will be measured by assessing the daily mean steps
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2021

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

April 30, 2021

First Submitted That Met QC Criteria

April 30, 2021

First Posted (Actual)

May 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY21040122
  • K23DK125719-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Polycystic Ovary Syndrome

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe