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Clinical Trials/NCT04874415
NCT04874415
Completed
Not Applicable

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

University of Pittsburgh1 site in 1 country75 target enrollmentStarted: November 16, 2021Last updated:
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ConditionsType 2 DiabetesPreDiabetesInsulin ResistancePolycystic Ovary Syndrome

Overview

Phase
Not Applicable
Status
Completed
Enrollment
75
Locations
1
Primary Endpoint
Change in Moderate to Vigorous Physical Activity (MVPA)
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Detailed Description

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
13 Years to 22 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change in Moderate to Vigorous Physical Activity (MVPA)

Time Frame: 12 weeks

Effects of time spent in MVPA was measured by assessing the change in weekly mean minutes in MVPA per day from baseline

Secondary Outcomes

  • 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)
  • Change in Triglycerides(From baseline to follow-up in-person study visits, separated by 3 months)
  • Change in Low-density Lipoprotein (LDL)(From baseline to follow-up in-person study visits, separated by 3 months)
  • Change in High-density Lipoprotein (HDL)(From baseline to follow-up in-person study visits, separated by 3 months)
  • Change in ALT(From baseline to follow-up in-person study visits, separated by 3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mary Ellen Vajravelu, MD

Assistant Professor

University of Pittsburgh

Study Sites (1)

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