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Behavioral Economics for Activity Motivation in Adolescents (BEAM)

Primary Purpose

Type 2 Diabetes, PreDiabetes, Insulin Resistance

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1RLD
1RLW
1RGD
1RGW
2RLD
2RLW
2RGD
2RGW
1FLD
1FLW
1FGD
1FGW
2FLD
2FLW
2FGD
2FGW
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes

Eligibility Criteria

13 Years - 22 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • UPMC Children's Hospital of PittsburghRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Condition 1

Condition 2

Condition 3

Condition 4

Condition 5

Condition 6

Condition 7

Condition 8

Condition 9

Condition 10

Condition 11

Condition 12

Condition 13

Condition 14

Condition 15

Condition 16

Arm Description

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Moderate to Vigorous Physical Activity (MVPA)
Effects of time spent in MVPA will be measured by assessing the weekly mean minutes in MVPA per day

Secondary Outcome Measures

Daily Step Count
Daily step count will be measured by assessing the daily mean steps

Full Information

First Posted
April 30, 2021
Last Updated
September 7, 2023
Sponsor
University of Pittsburgh
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04874415
Brief Title
Behavioral Economics for Activity Motivation in Adolescents (BEAM)
Official Title
Behavioral Economics for Activity Motivation in Adolescents and Young Adults With Prediabetes and Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, PreDiabetes, Insulin Resistance, Polycystic Ovary Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Condition 1
Arm Type
Experimental
Arm Description
1RLD=One text per day, ramped goal, loss incentive, daily goal time period.
Arm Title
Condition 2
Arm Type
Experimental
Arm Description
1RLW=One text per day, ramped goal, loss incentive, weekly goal time period.
Arm Title
Condition 3
Arm Type
Experimental
Arm Description
1RGD=One text per day, ramped goal, gain incentive, daily goal time period.
Arm Title
Condition 4
Arm Type
Experimental
Arm Description
1RGW=One text per day, ramped goal, gain incentive, weekly goal time period.
Arm Title
Condition 5
Arm Type
Experimental
Arm Description
2RLD=Two texts per day, ramped goal, loss incentive, daily goal time period.
Arm Title
Condition 6
Arm Type
Experimental
Arm Description
2RLW=Two texts per day, ramped goal, loss incentive, weekly goal time period.
Arm Title
Condition 7
Arm Type
Experimental
Arm Description
2RGD=Two texts per day, ramped goal, gain incentive, daily goal time period.
Arm Title
Condition 8
Arm Type
Experimental
Arm Description
2RGW=Two texts per day, ramped goal, gain incentive, weekly goal time period.
Arm Title
Condition 9
Arm Type
Experimental
Arm Description
1FLD=One text per day, fixed goal, loss incentive, daily goal time period.
Arm Title
Condition 10
Arm Type
Experimental
Arm Description
1FLW=One text per day, fixed goal, loss incentive, weekly goal time period.
Arm Title
Condition 11
Arm Type
Experimental
Arm Description
1FGD=One text per day, fixed goal, gain incentive, daily goal time period.
Arm Title
Condition 12
Arm Type
Experimental
Arm Description
1FGW=One text per day, fixed goal, gain incentive, weekly goal time period.
Arm Title
Condition 13
Arm Type
Experimental
Arm Description
2FLD=Two texts per day, fixed goal, loss incentive, daily goal time period.
Arm Title
Condition 14
Arm Type
Experimental
Arm Description
2FLW=Two texts per day, fixed goal, loss incentive, weekly goal time period.
Arm Title
Condition 15
Arm Type
Experimental
Arm Description
2FGD=Two texts per day, fixed goal, gain incentive, daily goal time period.
Arm Title
Condition 16
Arm Type
Experimental
Arm Description
2FGW=Two texts per day, fixed goal, gain incentive, weekly goal time period.
Intervention Type
Behavioral
Intervention Name(s)
1RLD
Intervention Description
1RLD=One text per day, ramped goal, loss incentive, daily goal time period
Intervention Type
Behavioral
Intervention Name(s)
1RLW
Intervention Description
1RLW=One text per day, ramped goal, loss incentive, weekly goal time period.
Intervention Type
Behavioral
Intervention Name(s)
1RGD
Intervention Description
1RGD=One text per day, ramped goal, gain incentive, daily goal time period.
Intervention Type
Behavioral
Intervention Name(s)
1RGW
Intervention Description
One text per day, ramped goal, gain incentive, weekly goal time period.
Intervention Type
Behavioral
Intervention Name(s)
2RLD
Intervention Description
Two texts per day, ramped goal, loss incentive, daily goal time period.
Intervention Type
Behavioral
Intervention Name(s)
2RLW
Intervention Description
Two texts per day, ramped goal, loss incentive, weekly goal time period.
Intervention Type
Behavioral
Intervention Name(s)
2RGD
Intervention Description
Two texts per day, ramped goal, gain incentive, daily goal time period.
Intervention Type
Behavioral
Intervention Name(s)
2RGW
Intervention Description
Two texts per day, ramped goal, gain incentive, weekly goal time period.
Intervention Type
Behavioral
Intervention Name(s)
1FLD
Intervention Description
One text per day, fixed goal, loss incentive, daily weekly goal time period.
Intervention Type
Behavioral
Intervention Name(s)
1FLW
Intervention Description
One text per day, fixed goal, loss incentive, weekly goal time period.
Intervention Type
Behavioral
Intervention Name(s)
1FGD
Intervention Description
One text per day, fixed goal, gain incentive, daily goal time period.
Intervention Type
Behavioral
Intervention Name(s)
1FGW
Intervention Description
One text per day, fixed goal, gain incentive, weekly goal time period.
Intervention Type
Behavioral
Intervention Name(s)
2FLD
Intervention Description
Two texts per day, fixed goal, loss incentive, daily goal time period.
Intervention Type
Behavioral
Intervention Name(s)
2FLW
Intervention Description
Two texts per day, fixed goal, loss incentive, weekly goal time period.
Intervention Type
Behavioral
Intervention Name(s)
2FGD
Intervention Description
Two texts per day, fixed goal, gain incentive, daily goal time period.
Intervention Type
Behavioral
Intervention Name(s)
2FGW
Intervention Description
Two texts per day, fixed goal, gain incentive, weekly goal time period.
Primary Outcome Measure Information:
Title
Moderate to Vigorous Physical Activity (MVPA)
Description
Effects of time spent in MVPA will be measured by assessing the weekly mean minutes in MVPA per day
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Daily Step Count
Description
Daily step count will be measured by assessing the daily mean steps
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary E Vajravelu, MD
Phone
412-692-6533
Email
MaryEllen.Vajravelu@pitt.edu
Facility Information:
Facility Name
UPMC Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary E Vajravelu, MD
Phone
412-692-6533
Email
MaryEllen.Vajravelu@pitt.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Behavioral Economics for Activity Motivation in Adolescents (BEAM)

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