Skip to main content
OpenTrials
Completed

NCT Number: NCT04874415

Behavioral Economics for Activity Motivation in Adolescents (BEAM)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Adnexal Diseases Cysts Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome PreDiabetes Prediabetic State Urogenital Diseases

Age range

13 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1RLD

Behavioral

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

1RLW

Behavioral

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

1RGD

Behavioral

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

1RGW

Behavioral

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

2RLD

Behavioral

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

2RLW

Behavioral

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

2RGD

Behavioral

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

2RGW

Behavioral

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

1FLD

Behavioral

One text per day, fixed goal, loss incentive, daily weekly goal time period.

1FLW

Behavioral

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

1FGD

Behavioral

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

1FGW

Behavioral

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

2FLD

Behavioral

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

2FLW

Behavioral

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

2FGD

Behavioral

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

2FGW

Behavioral

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

Primary outcomes

  1. 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

  1. Change in Daily Step Count

    Time frame: 12 weeks

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

  2. Change in BMI Z-score

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

    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.

  3. Change in Plasma Glucose

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

    mg/dL; obtained fasting

  4. Change in Insulin

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

    uIU/mL; obtained fasting

  5. Change in Hemoglobin A1c

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

    Percent (%)

  6. Change in Triglycerides

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

    mg/dL; obtained fasting

  7. Change in Low-density Lipoprotein (LDL)

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

    mg/dL; obtained fasting

  8. Change in High-density Lipoprotein (HDL)

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

    mg/dL; obtained fasting

  9. Change in ALT

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

    U/L

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 5, 2021
Registry last updated
Oct 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.