NCT04874415

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 mobile health (mHealth) intervention that uses behavioral economic-informed financial incentives and text messaging to promote physical activity in AYA with T2D and prediabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

November 16, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2024

Completed
1 year until next milestone

Results Posted

Study results publicly available

October 9, 2025

Completed
Last Updated

October 28, 2025

Status Verified

October 1, 2025

Enrollment Period

2.9 years

First QC Date

April 30, 2021

Results QC Date

September 19, 2025

Last Update Submit

October 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    12 weeks

Secondary Outcomes (9)

  • Change in Daily Step Count

    12 weeks

  • Change in BMI Z-score

    From baseline to follow-up in-person study visits, separated by 3 months

  • Change in Plasma Glucose

    From baseline to follow-up in-person study visits, separated by 3 months

  • Change in Insulin

    From baseline to follow-up in-person study visits, separated by 3 months

  • Change in Hemoglobin A1c

    From baseline to follow-up in-person study visits, separated by 3 months

  • +4 more secondary outcomes

Study Arms (16)

Condition 1

EXPERIMENTAL

1RLD=One text per day, ramped goal, loss incentive, daily goal time period.

Behavioral: 1RLD

Condition 2

EXPERIMENTAL

1RLW=One text per day, ramped goal, loss incentive, weekly goal time period.

Behavioral: 1RLW

Condition 3

EXPERIMENTAL

1RGD=One text per day, ramped goal, gain incentive, daily goal time period.

Behavioral: 1RGD

Condition 4

EXPERIMENTAL

1RGW=One text per day, ramped goal, gain incentive, weekly goal time period.

Behavioral: 1RGW

Condition 5

EXPERIMENTAL

2RLD=Two texts per day, ramped goal, loss incentive, daily goal time period.

Behavioral: 2RLD

Condition 6

EXPERIMENTAL

2RLW=Two texts per day, ramped goal, loss incentive, weekly goal time period.

Behavioral: 2RLW

Condition 7

EXPERIMENTAL

2RGD=Two texts per day, ramped goal, gain incentive, daily goal time period.

Behavioral: 2RGD

Condition 8

EXPERIMENTAL

2RGW=Two texts per day, ramped goal, gain incentive, weekly goal time period.

Behavioral: 2RGW

Condition 9

EXPERIMENTAL

1FLD=One text per day, fixed goal, loss incentive, daily goal time period.

Behavioral: 1FLD

Condition 10

EXPERIMENTAL

1FLW=One text per day, fixed goal, loss incentive, weekly goal time period.

Behavioral: 1FLW

Condition 11

EXPERIMENTAL

1FGD=One text per day, fixed goal, gain incentive, daily goal time period.

Behavioral: 1FGD

Condition 12

EXPERIMENTAL

1FGW=One text per day, fixed goal, gain incentive, weekly goal time period.

Behavioral: 1FGW

Condition 13

EXPERIMENTAL

2FLD=Two texts per day, fixed goal, loss incentive, daily goal time period.

Behavioral: 2FLD

Condition 14

EXPERIMENTAL

2FLW=Two texts per day, fixed goal, loss incentive, weekly goal time period.

Behavioral: 2FLW

Condition 15

EXPERIMENTAL

2FGD=Two texts per day, fixed goal, gain incentive, daily goal time period.

Behavioral: 2FGD

Condition 16

EXPERIMENTAL

2FGW=Two texts per day, fixed goal, gain incentive, weekly goal time period.

Behavioral: 2FGW

Interventions

1RLDBEHAVIORAL

1RLD=One text per day, ramped goal, loss incentive, daily goal time period

Condition 1
1RLWBEHAVIORAL

1RLW=One text per day, ramped goal, loss incentive, weekly goal time period.

Condition 2
1RGDBEHAVIORAL

1RGD=One text per day, ramped goal, gain incentive, daily goal time period.

Condition 3
1RGWBEHAVIORAL

One text per day, ramped goal, gain incentive, weekly goal time period.

Condition 4
2RLDBEHAVIORAL

Two texts per day, ramped goal, loss incentive, daily goal time period.

Condition 5
2RLWBEHAVIORAL

Two texts per day, ramped goal, loss incentive, weekly goal time period.

Condition 6
2RGDBEHAVIORAL

Two texts per day, ramped goal, gain incentive, daily goal time period.

Condition 7
2RGWBEHAVIORAL

Two texts per day, ramped goal, gain incentive, weekly goal time period.

Condition 8
1FLDBEHAVIORAL

One text per day, fixed goal, loss incentive, daily weekly goal time period.

Condition 9
1FLWBEHAVIORAL

One text per day, fixed goal, loss incentive, weekly goal time period.

Condition 10
1FGDBEHAVIORAL

One text per day, fixed goal, gain incentive, daily goal time period.

Condition 11
1FGWBEHAVIORAL

One text per day, fixed goal, gain incentive, weekly goal time period.

Condition 12
2FLDBEHAVIORAL

Two texts per day, fixed goal, loss incentive, daily goal time period.

Condition 13
2FLWBEHAVIORAL

Two texts per day, fixed goal, loss incentive, weekly goal time period.

Condition 14
2FGDBEHAVIORAL

Two texts per day, fixed goal, gain incentive, daily goal time period.

Condition 15
2FGWBEHAVIORAL

Two texts per day, fixed goal, gain incentive, weekly goal time period.

Condition 16

Eligibility Criteria

Age13 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \) Males or females age 13 to 22 years.
  • \) Overweight or obese (BMI ≥85th percentile for age/sex, or ≥25 kg/m2 for participants ≥18 years)
  • \) Diagnosis with prediabetes or type 2 diabetes
  • \) Consent (subjects 18 and older), Parental/guardian permission (subjects 13-17), assent (subjects 13-17)
  • \) Willingness to wear Fitbit during waking hours daily for duration of run-in and intervention.
  • \) Possession of a smartphone.

You may not qualify if:

  • \) Potential subject unable to speak or read in English
  • \) Severe cognitive impairment
  • \) Permanent or temporary physical disability that impairs ambulation or precludes engagement in MVPA
  • \) Current pregnancy
  • \) Previously-diagnosed or current restrictive or purging eating disorder
  • \) Moderate to vigorous physical activity (MVPA) \>30 minutes per day or Fitbit wear \< 4 days during second week of 2-week run-in period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Prediabetic StateInsulin ResistancePolycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal Disorders

Results Point of Contact

Title
Dr. Mary Ellen Vajravelu
Organization
University of Pittsburgh

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 30, 2021

First Posted

May 5, 2021

Study Start

November 16, 2021

Primary Completion

October 4, 2024

Study Completion

October 4, 2024

Last Updated

October 28, 2025

Results First Posted

October 9, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations