Community-based Adolescent Diabetes Prevention Program

Mount Sinai Health System

Status: Completed

Conditions: Pre-Diabetes

Treatments: Behavioral: TEEN HEED

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02458131

GCO 13-0901

5K23DK101692-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The number of youth with type 2 diabetes is predicted to quadruple by 2050, with a disproportionate increase among minority youth. The research proposed in this Career Development Award will use community-based participatory research methodology as well as novel strategies (peer education and mobile health technologies) to design, implement and evaluate a diabetes prevention intervention for at-risk ethnic minority youth in an urban community with high disease burden.

Full description

Approach: The proposed research addresses diabetes risk and prevention among racial/ethnic minority adolescents in East Harlem (EH), NY. Aim 1 will use qualitative methods to explore the best strategies for using peer education for diabetes risk reduction in youth and the potential role of mobile health technologies in improving adherence to behavioral modification plans. Aim 2 will utilize findings from preliminary studies and Aim 1 to design and evaluate a pilot community-based intervention to 1) maintain/reduce BMI (primary outcome), 2) improve adolescent dietary, physical activity and weight control behaviors, and 3) improve other measures of diabetes risk. Data will be collected at baseline, immediately after the intervention (3 months) and at one year in the intervention and wait list control groups. Aim 3 involves refining the pilot intervention based on an examination of intervention feasibility, acceptability, and sustainability and planning for a future R01.

Enrollment: 90 patients

Sex: All

Ages: 13 to 19 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for pre-diabetes screening:

• Adolescents ages 13-19 years of age

• English speaking

• Residents of East Harlem or members of an East Harlem Institution. Membership in an East Harlem institution includes the following:

  1. attending a school in East Harlem
  2. attending an after school or recreational activity in East Harlem
  3. receiving health care in East Harlem Proof of address or membership in an East Harlem institution will not be asked.

• At risk for diabetes (overweight/obese based on measured BMI percentile and with either a parent or grandparent with type 2 diabetes)

• No plans to relocate from New York City in the next year

Note: additional inclusion criteria for participation in workshops include diagnosis of pre-diabetes based on oral glucose tolerance test

Exclusion Criteria for pre-diabetes screening:

• <13 or >19 years of age
• Previous diagnosis of diabetes
• BMI percentile <85th percentile for age and gender based on Centers for Disease Control and Prevention definition
• Currently pregnant
• Speaking a language other than English
• On medications that may raise or lower blood sugar
• Plans to relocate from New York City within one year of enrollment-

Note: additional exclusion criteria for participation in workshops include fingerstick glucoses outside the pre-diabetes range during oral glucose tolerance testing and any cognitive or physical impairment that would preclude comprehension of the group educational program

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 2 patient groups

TEEN HEED

Experimental group

Description:

Adolescent pre-diabetics will receive 8-12 weekly peer-led diabetes prevention educational workshops in community sites. The in-person group workshops will be supplemented by support through mobile health technologies such as text messaging and social media.

Treatment:

Behavioral: TEEN HEED

Wait List Control

No Intervention group

Description:

Adolescent pre-diabetics in this group will not receive any intervention until collection of all follow up data and will then be offered the same intervention as the participants in the experimental arm.