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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Johns Hopkins Bloomberg School of Public Health
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01910727
First received: July 17, 2013
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Diabetes
Behavioral: Together on Diabetes-Hopkins

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Change in percent of total calories from fat from baseline through 12 months follow-up [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increased physical activity levels between baseline and 12 months follow-up [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
  • Decreased body mass index between baseline and 12 months follow-up [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
  • Improvement in point of care Hemoglobin A1C level between baseline and 12 month follow-up [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
  • Decrease in waist circumference between baseline and 12 months follow-up [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
  • Decreased blood pressure between baseline and 12 months follow-up [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
  • Improvements in youth diabetes knowledge test score between baseline and 12 months follow-up [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
  • Improved score on Pediatric quality of life assessment (Ped-QL) between baseline and 12 months follow-up [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
  • Increased numbers of family members involved in diabetes support care between baseline and 12 months follow-up [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
  • Increased numbers of individuals having been screen for diabetes between baseline and 12 months follow-up [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Together on Diabetes-Hopkins 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.

Detailed Description:

This is a single group pre-post study designed to evaluate the feasibility and effectiveness of a pilot intervention at improving the prevention and management of type 2 diabetes among American Indian youth. The intervention uses a Family Health Coach model to work with families of youth with diabetes or at high risk of diabetes. Health Coaches visit families in their homes and conduct intervention sessions with both youth and a designated adult 'support person' (e.g., parent, guardian, etc). For Youth Participants, the pilot intervention consists of 12 sessions (45-60 minutes in duration) delivered during a 6-month intervention phase, plus 6 check-ins delivered during a 6-month follow-up phase. There are also 4 optional social support visits for the Youth Participants in order to provide necessary assistance with challenges the youth may be facing. For Support Persons, the pilot intervention consists of 4 family skill building sessions (20-30 minutes in length) delivered during the first 4 months of the Youth Participant's intervention phase. Support Persons will also be welcomed and encouraged to attend any of the Youth Participant sessions. All sessions are designed to be taught at the participant's home, but they may also occur at another location chosen by the participant (e.g. school, study office, clinic). Outcome data will be collected at Baseline, 3 months following Baseline, 6 months following Baseline, and 12 months following Baseline.

  Eligibility

Ages Eligible for Study:   10 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

(YOUTH PARTICIPANT) --

  • American Indian youth aged 10-19 years old at enrollment
  • Resides within 1-hour transportation range (~ 50 miles) of the participating Indian Health Service (IHS) medical facilities (Tuba City, Arizona; Chinle, Arizona; Shiprock, New Mexico; Whiteriver, Arizona).
  • Parent/guardian consent for youth under 18 years old.
  • Referral from an Indian Health Services provider indicating a diagnosis by laboratory test of type 2 diabetes or pre-diabetes OR considered at-risk for type 2 diabetes based on BMI ≥ 85th percentile and qualifying lab test

(SUPPORT PERSON) --

  • Adults 18 years of age or older
  • Identified on the Youth Participant consent form as the preferred Support Person to be enrolled in the program
  • Living with the enrolled Youth Participant or within 15 miles of the youth

Exclusion Criteria:

(YOUTH PARTICIPANT)

  • Females who are pregnant or nursing or are planning to become pregnant within one year of enrollment
  • Diabetes due to secondary causes, such as exogenous steroids, Cushing's, or Cystic Fibrosis
  • Youth with type 1 diabetes.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01910727

Contacts
Contact: Allison Barlow, MPH, MA 410-955-6931 abarlow@jhsph.edu

Locations
United States, Maryland
Johns Hopkins Center for American Indian Health Recruiting
Baltimore, Maryland, United States, 21205
Contact: Allison Barlow, MPH, MA    410-955-6931    abarlow@jhsph.edu   
Principal Investigator: Allison Barlow, MPH, MA         
Sub-Investigator: Nicole Neault, MPH         
Sub-Investigator: Britta Mullany, PhD         
Sub-Investigator: Rachel Strom, MPH         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
Principal Investigator: Allison Barlow, MPH, MA Johns Hopkins Bloomberg School of Public Health
  More Information

No publications provided

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01910727     History of Changes
Other Study ID Numbers: Together on Diabetes - JHSPH
Study First Received: July 17, 2013
Last Updated: July 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
American Indian
Diabetes
Pre-diabetes
Family health Coach

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014