DiabetesNCT01910727
Together on Diabetes Study: Evaluation of a Pilot Diabetes Prevention and Management Program for American Indian Youth
A study testing Together on Diabetes-Hopkins in people with Diabetes, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Together on Diabetes-Hopkins
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 506 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- (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) --
Show all 9Show fewer
- 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
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Center for American Indian Health
Baltimore, Maryland, 21205
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Together on Diabetes-Hopkins
- Keywords
- American Indian, Diabetes, Pre-diabetes, Family health Coach
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Together on Diabetes-HopkinsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Together on Diabetes-Hopkins | Experimental | Not described Receives: Behavioral: Together on Diabetes-Hopkins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percent of total calories from fat from baseline through 12 months follow-up
Measured: 12 months follow-up
Secondary outcomes (9)
Increased physical activity levels between baseline and 12 months follow-up
Measured: 12 months follow-up
Decreased body mass index between baseline and 12 months follow-up
Measured: 12 months follow-up
Improvement in point of care Hemoglobin A1C level between baseline and 12 month follow-up
Measured: 12 months follow-up
Decrease in waist circumference between baseline and 12 months follow-up
Measured: 12 months follow-up
Decreased blood pressure between baseline and 12 months follow-up
Measured: 12 months follow-up
Improvements in youth diabetes knowledge test score between baseline and 12 months follow-up
Measured: 12 months follow-up
Improved score on Pediatric quality of life assessment (Ped-QL) between baseline and 12 months follow-up
Measured: 12 months follow-up
Increased numbers of family members involved in diabetes support care between baseline and 12 months follow-up
Measured: 12 months follow-up
Increased numbers of individuals having been screen for diabetes between baseline and 12 months follow-up
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startDec 2011
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 506 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison Barlow, MPH, MA, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910727
- Sponsor's protocol ID
- Together on Diabetes - JHSPH
- Status last verified
- Mar 2017
- First submitted
- 17 Jul 2013
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Together on Diabetes Study: Evaluation of a Pilot Diabetes Prevention and Management Program for American Indian Youth
- ClinicalTrials.gov ID
- NCT01910727
- Acronym / sponsor ID
- Together on Diabetes - JHSPH
- Conditions
- Diabetes
- Keywords
- American Indian, Diabetes, Pre-diabetes, Family health Coach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 506 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Together on Diabetes-Hopkins | Experimental | Behavioral: Together on Diabetes-Hopkins |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- (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
Key exclusion criteria (4 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Together on Diabetes-HopkinsThe 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. | Behavioural | Together on Diabetes-Hopkins |
Primary outcome
Change in percent of total calories from fat from baseline through 12 months follow-up
Time frame: 12 months follow-up
9 secondary outcomes
Increased physical activity levels between baseline and 12 months follow-up
Time frame: 12 months follow-up
Decreased body mass index between baseline and 12 months follow-up
Time frame: 12 months follow-up
Improvement in point of care Hemoglobin A1C level between baseline and 12 month follow-up
Time frame: 12 months follow-up
Decrease in waist circumference between baseline and 12 months follow-up
Time frame: 12 months follow-up
Decreased blood pressure between baseline and 12 months follow-up
Time frame: 12 months follow-up
Improvements in youth diabetes knowledge test score between baseline and 12 months follow-up
Time frame: 12 months follow-up
Improved score on Pediatric quality of life assessment (Ped-QL) between baseline and 12 months follow-up
Time frame: 12 months follow-up
Increased numbers of family members involved in diabetes support care between baseline and 12 months follow-up
Time frame: 12 months follow-up
Increased numbers of individuals having been screen for diabetes between baseline and 12 months follow-up
Time frame: 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Barlow, MPH, MA principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Together on Diabetes-Hopkins in people with Diabetes, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percent of total calories from fat from baseline through 12 months follow-up (time frame: 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.