Behavioral Economics for Activity Motivation in Adolescents (BEAM)

NCT ID: NCT04874415

Last Updated: 2025-10-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-16

Study Completion Date

2024-10-04

Brief Summary

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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.

Detailed Description

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

Conditions

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Type 2 Diabetes PreDiabetes Insulin Resistance Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Condition 1

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

Group Type EXPERIMENTAL

1RLD

Intervention Type BEHAVIORAL

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

Condition 2

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

Group Type EXPERIMENTAL

1RLW

Intervention Type BEHAVIORAL

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

Condition 3

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

Group Type EXPERIMENTAL

1RGD

Intervention Type BEHAVIORAL

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

Condition 4

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

Group Type EXPERIMENTAL

1RGW

Intervention Type BEHAVIORAL

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

Condition 5

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

Group Type EXPERIMENTAL

2RLD

Intervention Type BEHAVIORAL

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

Condition 6

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

Group Type EXPERIMENTAL

2RLW

Intervention Type BEHAVIORAL

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

Condition 7

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

Group Type EXPERIMENTAL

2RGD

Intervention Type BEHAVIORAL

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

Condition 8

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

Group Type EXPERIMENTAL

2RGW

Intervention Type BEHAVIORAL

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

Condition 9

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

Group Type EXPERIMENTAL

1FLD

Intervention Type BEHAVIORAL

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

Condition 10

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

Group Type EXPERIMENTAL

1FLW

Intervention Type BEHAVIORAL

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

Condition 11

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

Group Type EXPERIMENTAL

1FGD

Intervention Type BEHAVIORAL

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

Condition 12

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

Group Type EXPERIMENTAL

1FGW

Intervention Type BEHAVIORAL

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

Condition 13

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

Group Type EXPERIMENTAL

2FLD

Intervention Type BEHAVIORAL

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

Condition 14

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

Group Type EXPERIMENTAL

2FLW

Intervention Type BEHAVIORAL

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

Condition 15

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

Group Type EXPERIMENTAL

2FGD

Intervention Type BEHAVIORAL

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

Condition 16

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

Group Type EXPERIMENTAL

2FGW

Intervention Type BEHAVIORAL

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

Interventions

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1RLD

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

Intervention Type BEHAVIORAL

1RLW

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

Intervention Type BEHAVIORAL

1RGD

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

Intervention Type BEHAVIORAL

1RGW

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

Intervention Type BEHAVIORAL

2RLD

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

Intervention Type BEHAVIORAL

2RLW

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

Intervention Type BEHAVIORAL

2RGD

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

Intervention Type BEHAVIORAL

2RGW

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

Intervention Type BEHAVIORAL

1FLD

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

Intervention Type BEHAVIORAL

1FLW

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

Intervention Type BEHAVIORAL

1FGD

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

Intervention Type BEHAVIORAL

1FGW

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

Intervention Type BEHAVIORAL

2FLD

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

Intervention Type BEHAVIORAL

2FLW

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

Intervention Type BEHAVIORAL

2FGD

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

Intervention Type BEHAVIORAL

2FGW

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Mary Ellen Vajravelu, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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K23DK125719-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY21040122

Identifier Type: -

Identifier Source: org_study_id

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