Behavioral Economics for Activity Motivation in Adolescents (BEAM)

Sponsor

University of Pittsburgh (Other)

Overall Status

Recruiting

CT.gov ID

NCT04874415

Collaborator

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

Enrollment

Location

Arms

32.5

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes PreDiabetes Insulin Resistance Polycystic Ovary Syndrome	Behavioral: 1RLD Behavioral: 1RLW Behavioral: 1RGD Behavioral: 1RGW Behavioral: 2RLD Behavioral: 2RLW Behavioral: 2RGD Behavioral: 2RGW Behavioral: 1FLD Behavioral: 1FLW Behavioral: 1FGD Behavioral: 1FGW Behavioral: 2FLD Behavioral: 2FLW Behavioral: 2FGD Behavioral: 2FGW	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Behavioral Economics for Activity Motivation in Adolescents and Young Adults With Prediabetes and Type 2 Diabetes

Actual Study Start Date :

Nov 16, 2021

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Moderate to Vigorous Physical Activity (MVPA) [12 weeks]
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 [12 weeks]
Daily step count will be measured by assessing the daily mean steps

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 22 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15224

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mary Ellen Vajravelu, Assistant Professor, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT04874415

Other Study ID Numbers:

STUDY21040122
K23DK125719-01

First Posted:

May 5, 2021

Last Update Posted:

Nov 18, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Diabetes Mellitus, Type 2

Insulin Resistance

Prediabetic State

Glucose Intolerance

Study Results

No Results Posted as of Nov 18, 2021

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