Behavioral Economics for Activity Motivation in Adolescents (BEAM)

October 11, 2025 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 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Some secondary outcome measures from the protocol were inadvertently left out when creating the registration and have been added with the results.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Moderate to Vigorous Physical Activity (MVPA)
Time Frame: 12 weeks
Effects of time spent in MVPA was measured by assessing the change in weekly mean minutes in MVPA per day from baseline
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Daily Step Count
Time Frame: 12 weeks
Daily step count will be measured by assessing the change in daily mean steps from baseline
12 weeks
Change in Plasma Glucose
Time Frame: From baseline to follow-up in-person study visits, separated by 3 months
mg/dL; obtained fasting
From baseline to follow-up in-person study visits, separated by 3 months
Change in Insulin
Time Frame: From baseline to follow-up in-person study visits, separated by 3 months
uIU/mL; obtained fasting
From baseline to follow-up in-person study visits, separated by 3 months
Change in Hemoglobin A1c
Time Frame: From baseline to follow-up in-person study visits, separated by 3 months
Percent (%)
From baseline to follow-up in-person study visits, separated by 3 months
Change in Triglycerides
Time Frame: From baseline to follow-up in-person study visits, separated by 3 months
mg/dL; obtained fasting
From baseline to follow-up in-person study visits, separated by 3 months
Change in Low-density Lipoprotein (LDL)
Time Frame: From baseline to follow-up in-person study visits, separated by 3 months
mg/dL; obtained fasting
From baseline to follow-up in-person study visits, separated by 3 months
Change in High-density Lipoprotein (HDL)
Time Frame: From baseline to follow-up in-person study visits, separated by 3 months
mg/dL; obtained fasting
From baseline to follow-up in-person study visits, separated by 3 months
Change in ALT
Time Frame: From baseline to follow-up in-person study visits, separated by 3 months
U/L
From baseline to follow-up in-person study visits, separated by 3 months
Change in BMI Z-score
Time Frame: From baseline to follow-up in-person study visits, separated by 3 months
Z-score calculated using "zanthro" package in Stata, according to U.S. CDC growth charts. The BMI Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched adolescents and young adults). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population. A Z-score of 0 represents the population mean. BMI Z-scores greater than 1.645 are consistent with pediatric obesity.
From baseline to follow-up in-person study visits, separated by 3 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 4, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 4, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

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.

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