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Together on Diabetes Study: Evaluation of a Pilot Diabetes Prevention and Management Program for American Indian Youth

NCT01910727 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 506

Last updated 2017-03-20

No results posted yet for this study

Summary

The objective of the Together on Diabetes study is to test the efficacy of a pilot intervention to improve the prevention and management of type 2 diabetes among American Indian youth.

The primary aim of this study is to determine the impact of the Together on Diabetes pilot intervention on youth diabetes risk behaviors, including:

* Improvement in youth dietary intake, with a specific focus on reducing the percent of total calories from fat.
* Improvement in youth physical activity, with a specific focus on increasing the number of minutes of physical activity each week.

An additional primary aim of the study is to determine the feasibility and acceptability of the pilot intervention and evaluation, including program adherence and program satisfaction.

The secondary aim of this study is to determine the feasibility of collecting data to determine program impact on a number of physiological measures.

Conditions

Interventions

BEHAVIORAL

Together on Diabetes-Hopkins

The Johns Hopkins Center for American Indian Health, with support from Bristol-Myers Squibb Foundation, Inc. is adapting a Family Health Coach model for diabetes prevention with four southwestern tribal communities. Specifically, Johns Hopkins Center for American Indian Health has designed a paraprofessional delivered pilot intervention aimed at improving the prevention and management of type 2 diabetes among American Indian youth. For Youth Participants, the pilot intervention consists of 12 sessions delivered during a 6-month intervention phase, plus 6 check-ins delivered during a 6-month follow-up phase. For Support Persons, the pilot intervention consists of 4 family skill building sessions delivered during the first 4 months of the Youth Participant's intervention phase.

Sponsors & Collaborators

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Allison Barlow, MPH, MA · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01910727 on ClinicalTrials.gov