NCT02458131

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
1.5 years until next milestone

Study Start

First participant enrolled

November 11, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2019

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

2.8 years

First QC Date

May 22, 2015

Last Update Submit

November 20, 2019

Conditions

Pre-Diabetes

Keywords

community-based participatory researchadolescents

Outcome Measures

Primary Outcomes (2)

  • Change in body mass index (BMI)

    Change in BMI at post-intervention (approximately 3 months) as compared to baseline

    Baseline and 3 months

  • Change in BMI

    Change in BMI at 1 year as compared to baseline

    Baseline and 1 year

Secondary Outcomes (12)

  • Change in fasting blood glucose levels

    Baseline and 3 months

  • Change in fasting blood glucose levels

    Baseline and 1 year

  • Change in post prandial blood glucose level

    Baseline and 3 months

  • Change in post prandial blood glucose level

    Baseline and 1 year

  • Change in blood pressure

    Baseline and 3 months

  • +7 more secondary outcomes

Study Arms (2)

TEEN HEED

EXPERIMENTAL

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.

Behavioral: TEEN HEED

Wait List Control

NO INTERVENTION

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.

Interventions

TEEN HEEDBEHAVIORAL

Peer-led workshops will cover behavioral skills including goal setting, self-monitoring, problem solving, contingency management, coping skills, and social support.

TEEN HEED

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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:
  • attending a school in East Harlem
  • attending an after school or recreational activity in East Harlem
  • 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

You may not qualify if:

  • \<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-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Nita Vangeepuram, MD, MPH

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2015

First Posted

May 29, 2015

Study Start

November 11, 2016

Primary Completion

August 24, 2019

Study Completion

August 24, 2019

Last Updated

November 21, 2019

Record last verified: 2019-11

Locations

US(1)