Behavioral Economics for Activity Motivation in Adolescents (BEAM)

University of Pittsburgh75 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Type 2 Diabetes PreDiabetes Insulin Resistance Polycystic Ovary Syndrome

Interventions

1RLDBEHAVIORAL

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

1RLWBEHAVIORAL

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

1RGDBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 13 YearsMax age: 22 Years

Medical Language ↔ Plain English

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

Locations (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Change in Moderate to Vigorous Physical Activity (MVPA)

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

Time frame: 12 weeks

Secondary Outcomes

Change in Daily Step Count

Daily step count will be measured by assessing the change in daily mean steps from baseline

Time frame: 12 weeks

Change in BMI Z-score

Z-score calculated using "zanthro" package in Stata, according to U.S. CDC growth charts. The BMI Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched adolescents and young adults). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population. A Z-score of 0 represents the population mean. BMI Z-scores greater than 1.645 are consistent with pediatric obesity.

Time frame: From baseline to follow-up in-person study visits, separated by 3 months

Change in Plasma Glucose

mg/dL; obtained fasting

Time frame: From baseline to follow-up in-person study visits, separated by 3 months

Change in Insulin

uIU/mL; obtained fasting

Time frame: From baseline to follow-up in-person study visits, separated by 3 months

Change in Hemoglobin A1c

Percent (%)

Time frame: From baseline to follow-up in-person study visits, separated by 3 months

Change in Triglycerides

Data from ClinicalTrials.gov

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