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Behavioral Economics for Activity Motivation in Adolescents (BEAM)

University of Pittsburgh logo

University of Pittsburgh

Status

Completed

Conditions

Polycystic Ovary Syndrome
Insulin Resistance
Type 2 Diabetes
PreDiabetes

Treatments

Behavioral: 1FLW
Behavioral: 1FGW
Behavioral: 2FGD
Behavioral: 1RGW
Behavioral: 2RGW
Behavioral: 2FGW
Behavioral: 1RGD
Behavioral: 1FGD
Behavioral: 1RLW
Behavioral: 2RLW
Behavioral: 1RLD
Behavioral: 2RGD
Behavioral: 2FLW
Behavioral: 1FLD
Behavioral: 2RLD
Behavioral: 2FLD

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04874415
STUDY21040122
K23DK125719-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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

Enrollment

75 patients

Sex

All

Ages

13 to 22 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

75 participants in 16 patient groups

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

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Mary E Vajravelu, MD

Data sourced from clinicaltrials.gov

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