Type 2 DiabetesNCT04874415

Behavioral Economics for Activity Motivation in Adolescents (BEAM)

A study testing 1RLD, 1RLW and 1RGD in people with Type 2 Diabetes and PreDiabetes, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 13 to 22 years
Conditions the study is for: Type 2 Diabetes, PreDiabetes, Insulin Resistance
What is being tested?: 1RLD, 1RLW and 1RGD
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 1 siteUnited States
Study dates: 16 Nov 2021to 4 Oct 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 22 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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

Conditions: Type 2 Diabetes, PreDiabetes, Insulin Resistance, Polycystic Ovary Syndrome
Being tested: 1RLD, 1RLW, 1RGD, 1RGW, 2RLD
Medical subject headings: Diabetes Mellitus, Type 2, Prediabetic State, Insulin Resistance, Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

1RLDBehavioural
1RLD=One text per day, ramped goal, loss incentive, daily goal time period
1RLWBehavioural
1RLW=One text per day, ramped goal, loss incentive, weekly goal time period.
1RGDBehavioural
1RGD=One text per day, ramped goal, gain incentive, daily goal time period.
1RGWBehavioural
One text per day, ramped goal, gain incentive, weekly goal time period.
2RLDBehavioural
Two texts per day, ramped goal, loss incentive, daily goal time period.
2RLWBehavioural
Two texts per day, ramped goal, loss incentive, weekly goal time period.
2RGDBehavioural
Two texts per day, ramped goal, gain incentive, daily goal time period.
2RGWBehavioural
Two texts per day, ramped goal, gain incentive, weekly goal time period.
1FLDBehavioural
One text per day, fixed goal, loss incentive, daily weekly goal time period.
1FLWBehavioural
One text per day, fixed goal, loss incentive, weekly goal time period.
1FGDBehavioural
One text per day, fixed goal, gain incentive, daily goal time period.
1FGWBehavioural
One text per day, fixed goal, gain incentive, weekly goal time period.
2FLDBehavioural
Two texts per day, fixed goal, loss incentive, daily goal time period.
2FLWBehavioural
Two texts per day, fixed goal, loss incentive, weekly goal time period.
2FGDBehavioural
Two texts per day, fixed goal, gain incentive, daily goal time period.
2FGWBehavioural
Two texts per day, fixed goal, gain incentive, weekly goal time period.

Study groups in NCT04874415
Study group	Role	What they receive
Condition 1	Experimental	1RLD=One text per day, ramped goal, loss incentive, daily goal time period. Receives: Behavioral: 1RLD
Condition 2	Experimental	1RLW=One text per day, ramped goal, loss incentive, weekly goal time period. Receives: Behavioral: 1RLW
Condition 3	Experimental	1RGD=One text per day, ramped goal, gain incentive, daily goal time period. Receives: Behavioral: 1RGD
Condition 4	Experimental	1RGW=One text per day, ramped goal, gain incentive, weekly goal time period. Receives: Behavioral: 1RGW
Condition 5	Experimental	2RLD=Two texts per day, ramped goal, loss incentive, daily goal time period. Receives: Behavioral: 2RLD
Condition 6	Experimental	2RLW=Two texts per day, ramped goal, loss incentive, weekly goal time period. Receives: Behavioral: 2RLW
Condition 7	Experimental	2RGD=Two texts per day, ramped goal, gain incentive, daily goal time period. Receives: Behavioral: 2RGD
Condition 8	Experimental	2RGW=Two texts per day, ramped goal, gain incentive, weekly goal time period. Receives: Behavioral: 2RGW
Condition 9	Experimental	1FLD=One text per day, fixed goal, loss incentive, daily goal time period. Receives: Behavioral: 1FLD
Condition 10	Experimental	1FLW=One text per day, fixed goal, loss incentive, weekly goal time period. Receives: Behavioral: 1FLW
Condition 11	Experimental	1FGD=One text per day, fixed goal, gain incentive, daily goal time period. Receives: Behavioral: 1FGD
Condition 12	Experimental	1FGW=One text per day, fixed goal, gain incentive, weekly goal time period. Receives: Behavioral: 1FGW
Condition 13	Experimental	2FLD=Two texts per day, fixed goal, loss incentive, daily goal time period. Receives: Behavioral: 2FLD
Condition 14	Experimental	2FLW=Two texts per day, fixed goal, loss incentive, weekly goal time period. Receives: Behavioral: 2FLW
Condition 15	Experimental	2FGD=Two texts per day, fixed goal, gain incentive, daily goal time period. Receives: Behavioral: 2FGD
Condition 16	Experimental	2FGW=Two texts per day, fixed goal, gain incentive, weekly goal time period. Receives: Behavioral: 2FGW

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Moderate to Vigorous Physical Activity (MVPA)
Effects of time spent in MVPA was measured by assessing the change in weekly mean minutes in MVPA per day from baseline
Measured: 12 weeks

Secondary outcomes (9)

Change in Daily Step Count
Daily step count will be measured by assessing the change in daily mean steps from baseline
Measured: 12 weeks
Change in BMI Z-score
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.
Measured: From baseline to follow-up in-person study visits, separated by 3 months
Change in Plasma Glucose
mg/dL; obtained fasting
Measured: From baseline to follow-up in-person study visits, separated by 3 months
Change in Insulin
uIU/mL; obtained fasting
Measured: From baseline to follow-up in-person study visits, separated by 3 months
Change in Hemoglobin A1c
Percent (%)
Measured: From baseline to follow-up in-person study visits, separated by 3 months
Change in Triglycerides
mg/dL; obtained fasting
Measured: From baseline to follow-up in-person study visits, separated by 3 months
Change in Low-density Lipoprotein (LDL)
mg/dL; obtained fasting
Measured: From baseline to follow-up in-person study visits, separated by 3 months
Change in High-density Lipoprotein (HDL)
mg/dL; obtained fasting
Measured: From baseline to follow-up in-person study visits, separated by 3 months
Change in ALT
U/L
Measured: From baseline to follow-up in-person study visits, separated by 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Nov 20214 Oct 2024

First posted5 May 2021
Study start16 Nov 2021
Primary completion4 Oct 2024
Study completion4 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04874415
Sponsor's protocol ID: STUDY21040122
Other IDs: K23DK125719-01
Status last verified: Oct 2025
First submitted: 30 Apr 2021
Last updated: 28 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
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Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Not yet recruiting
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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Behavioral Economics for Activity Motivation in Adolescents and Young Adults With Prediabetes and Type 2 Diabetes
ClinicalTrials.gov ID: NCT04874415
Acronym / sponsor ID: STUDY21040122
Conditions: Type 2 Diabetes, PreDiabetes, Insulin Resistance, Polycystic Ovary Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 16 Nov 2021 (actual)
Primary completion: 4 Oct 2024 (actual)
Study completion: 4 Oct 2024 (actual)
First posted: 5 May 2021 (actual)
Results: Posted 9 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Other
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 16

Arm	Type	Receives
Condition 1	Experimental	Behavioral: 1RLD1RLD=One text per day, ramped goal, loss incentive, daily goal time period.
Condition 2	Experimental	Behavioral: 1RLW1RLW=One text per day, ramped goal, loss incentive, weekly goal time period.
Condition 3	Experimental	Behavioral: 1RGD1RGD=One text per day, ramped goal, gain incentive, daily goal time period.
Condition 4	Experimental	Behavioral: 1RGW1RGW=One text per day, ramped goal, gain incentive, weekly goal time period.
Condition 5	Experimental	Behavioral: 2RLD2RLD=Two texts per day, ramped goal, loss incentive, daily goal time period.
Condition 6	Experimental	Behavioral: 2RLW2RLW=Two texts per day, ramped goal, loss incentive, weekly goal time period.
Condition 7	Experimental	Behavioral: 2RGD2RGD=Two texts per day, ramped goal, gain incentive, daily goal time period.
Condition 8	Experimental	Behavioral: 2RGW2RGW=Two texts per day, ramped goal, gain incentive, weekly goal time period.
Condition 9	Experimental	Behavioral: 1FLD1FLD=One text per day, fixed goal, loss incentive, daily goal time period.
Condition 10	Experimental	Behavioral: 1FLW1FLW=One text per day, fixed goal, loss incentive, weekly goal time period.
Condition 11	Experimental	Behavioral: 1FGD1FGD=One text per day, fixed goal, gain incentive, daily goal time period.
Condition 12	Experimental	Behavioral: 1FGW1FGW=One text per day, fixed goal, gain incentive, weekly goal time period.
Condition 13	Experimental	Behavioral: 2FLD2FLD=Two texts per day, fixed goal, loss incentive, daily goal time period.
Condition 14	Experimental	Behavioral: 2FLW2FLW=Two texts per day, fixed goal, loss incentive, weekly goal time period.
Condition 15	Experimental	Behavioral: 2FGD2FGD=Two texts per day, fixed goal, gain incentive, daily goal time period.
Condition 16	Experimental	Behavioral: 2FGW2FGW=Two texts per day, fixed goal, gain incentive, weekly goal time period.

Who may qualify

Ages: 13 to 22 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
1RLD1RLD=One text per day, ramped goal, loss incentive, daily goal time period	Behavioural	Condition 1
1RLW1RLW=One text per day, ramped goal, loss incentive, weekly goal time period.	Behavioural	Condition 2
1RGD1RGD=One text per day, ramped goal, gain incentive, daily goal time period.	Behavioural	Condition 3
1RGWOne text per day, ramped goal, gain incentive, weekly goal time period.	Behavioural	Condition 4
2RLDTwo texts per day, ramped goal, loss incentive, daily goal time period.	Behavioural	Condition 5
2RLWTwo texts per day, ramped goal, loss incentive, weekly goal time period.	Behavioural	Condition 6
2RGDTwo texts per day, ramped goal, gain incentive, daily goal time period.	Behavioural	Condition 7
2RGWTwo texts per day, ramped goal, gain incentive, weekly goal time period.	Behavioural	Condition 8
1FLDOne text per day, fixed goal, loss incentive, daily weekly goal time period.	Behavioural	Condition 9
1FLWOne text per day, fixed goal, loss incentive, weekly goal time period.	Behavioural	Condition 10
1FGDOne text per day, fixed goal, gain incentive, daily goal time period.	Behavioural	Condition 11
1FGWOne text per day, fixed goal, gain incentive, weekly goal time period.	Behavioural	Condition 12
2FLDTwo texts per day, fixed goal, loss incentive, daily goal time period.	Behavioural	Condition 13
2FLWTwo texts per day, fixed goal, loss incentive, weekly goal time period.	Behavioural	Condition 14
2FGDTwo texts per day, fixed goal, gain incentive, daily goal time period.	Behavioural	Condition 15
2FGWTwo texts per day, fixed goal, gain incentive, weekly goal time period.	Behavioural	Condition 16

Primary outcome

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

9 secondary outcomes

Change in Daily Step Count
Time frame: 12 weeks
Change in BMI Z-score
Time frame: From baseline to follow-up in-person study visits, separated by 3 months
Change in Plasma Glucose
Time frame: 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
Change in Hemoglobin A1c
Time frame: 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
Change in Low-density Lipoprotein (LDL)
Time frame: 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
Change in ALT
Time frame: From baseline to follow-up in-person study visits, separated by 3 months

Results and safety

Results posted to the registry on 9 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1FLD	5	3
1FLW	4	3
1RLD	4	3
1RLW	5	3
1FGD	4	2
1FGW	3	2
1RGD	3	2
1RGW	4	2
2FLD	4	0
2FLW	5	2
2RLD	5	3
2RLW	4	3
2FGD	4	3
2FGW	4	3
2RGD	5	1
2RGW	4	3

Primary outcome: Change in Moderate to Vigorous Physical Activity (MVPA)

Time frame: 12 weeks. Least squares mean (95% Confidence Interval). Unit: minutes per day

Measure	Once Daily Text Message n = 21	Twice Daily Text Message n = 18	Fixed Step Count Goal n = 19	Ramped Step Count Goal n = 20	Loss Framed Incentive n = 20	Gain Framed Incentive n = 19	Daily Step Count Goal n = 18	Weekly Step Count Goal n = 21
Baseline	6.1 (3.6 to 8.6)	7.1 (3.0 to 11.3)	5.0 (1.8 to 8.2)	8.2 (3.7 to 12.8)	5.1 (2.0 to 8.1)	8.2 (3.6 to 12.7)	6.5 (3.3 to 9.7)	6.7 (3.1 to 10.3)
Change from baseline to 12 weeks	2.3 (-0.9 to 5.5)	1.8 (-2.9 to 6.5)	3.3 (-0.9 to 7.4)	0.8 (-4.0 to 5.7)	4.0 (-0.2 to 8.3)	0.07 (-4.7 to 4.9)	-0.2 (-3.1 to 2.8)	4.3 (-0.5 to 9.0)

Once Daily Text Message vs Twice Daily Text Message: Mean Difference (Final Values): -0.4 (95% CI -6.2 to 5.3)
Fixed Step Count Goal vs Ramped Step Count Goal: Mean Difference (Final Values): -2.4 (95% CI -9.4 to 4.6)
Loss Framed Incentive vs Gain Framed Incentive: Mean Difference (Final Values): -4.0 (95% CI -11 to 3.1)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: from enrollment until end of follow-up, up to 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1FLD	0 of 5 (0%)	2 of 5 (40%)	0 of 5
1FLW	0 of 4 (0%)	1 of 4 (25%)	0 of 4
1RLD	0 of 4 (0%)	2 of 4 (50%)	0 of 4
1RLW	0 of 5 (0%)	1 of 5 (20%)	0 of 5
1FGD	0 of 4 (0%)	0 of 4 (0%)	0 of 4
1FGW	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
1RGD	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
1RGW	0 of 4 (0%)	2 of 4 (50%)	0 of 4
2FLD	0 of 4 (0%)	2 of 4 (50%)	0 of 4
2FLW	0 of 5 (0%)	1 of 5 (20%)	0 of 5
2RLD	0 of 5 (0%)	1 of 5 (20%)	0 of 5
2RLW	0 of 4 (0%)	2 of 4 (50%)	0 of 4
2FGD	0 of 4 (0%)	0 of 4 (0%)	0 of 4
2FGW	0 of 4 (0%)	2 of 4 (50%)	0 of 4
2RGD	0 of 5 (0%)	0 of 5 (0%)	0 of 5
2RGW	0 of 4 (0%)	2 of 4 (50%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 1RLD, 1RLW and 1RGD in people with Type 2 Diabetes and PreDiabetes, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Moderate to Vigorous Physical Activity (MVPA) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04874415.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.