Pre-DiabetesNCT02458131
Community-based Adolescent Diabetes Prevention Program
A study testing TEEN HEED in people with Pre-Diabetes, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-Diabetes
- What is being tested?
- TEEN HEED
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2016to 24 Aug 2019
- 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- <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 locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: TEEN HEED: An Adolescent Peer Led Diabetes Prevention Intervention
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.
Read the detailed 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.
- Conditions
- Pre-Diabetes
- Being tested
- TEEN HEED
- Keywords
- community-based participatory research, adolescents
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEEN HEEDBehavioural
Peer-led workshops will cover behavioral skills including goal setting, self-monitoring, problem solving, contingency management, coping skills, and social support.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index (BMI)
Change in BMI at post-intervention (approximately 3 months) as compared to baseline
Measured: Baseline and 3 months
Change in BMI
Change in BMI at 1 year as compared to baseline
Measured: Baseline and 1 year
Secondary outcomes (12)
Change in fasting blood glucose levels
Change in fasting blood glucose levels at post-intervention (approximately 3 months) as compared to baseline
Measured: Baseline and 3 months
Change in fasting blood glucose levels
Change in fasting blood glucose levels at 1 year as compared to baseline
Measured: Baseline and 1 year
Change in post prandial blood glucose level
Change in post prandial blood glucose level at post-intervention (approximately 3 months) as compared to baseline
Measured: Baseline and 3 months
Change in post prandial blood glucose level
Change in post prandial blood glucose level at 1 year as compared to baseline
Measured: Baseline and 1 year
Change in blood pressure
Change in blood pressure at post-intervention (approximately 3 months) as compared to baseline
Measured: Baseline and 3 months
Change in blood pressure
Change in blood pressure at 1 year as compared to baseline
Measured: Baseline and 1 year
Change in percent body fat
Change in percent body fat at post-intervention (approximately 3 months) as compared to baseline
Measured: Baseline and 3 months
Change in percent body fat
Change in percent body fat at 1 year as compared to baseline
Measured: Baseline and 1 year
Change in waist circumference
Change in waist circumference at post-intervention (approximately 3 months) as compared to baseline
Measured: Baseline and 3 months
Change in waist circumference
Change in waist circumference at 1 year as compared to baseline
Measured: Baseline and 1 year
Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss
Change in knowledge, attitudes, beliefs and behaviors (from the TEEN HEED survey) at post-intervention (approximately 3 months) as compared to baseline
Measured: Baseline and 3 months
Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss
Change in knowledge, attitudes, beliefs and behaviors (from the TEEN HEED survey) at 1 year as compared to baseline
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study start11 Nov 2016
- Primary completion24 Aug 2019
- Study completion24 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-DiabetesStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nita Vangeepuram, MD, MPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458131
- Sponsor's protocol ID
- GCO 13-0901
- Other IDs
- 5K23DK101692-02
- Status last verified
- Nov 2019
- First submitted
- 22 May 2015
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEEN HEED: An Adolescent Peer Led Diabetes Prevention Intervention
- ClinicalTrials.gov ID
- NCT02458131
- Acronym / sponsor ID
- GCO 13-0901
- Conditions
- Pre-Diabetes
- Keywords
- community-based participatory research, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 11 Nov 2016 (actual)
- Primary completion
- 24 Aug 2019 (actual)
- Study completion
- 24 Aug 2019 (actual)
- First posted
- 29 May 2015 (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 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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEEN HEED | Experimental | Behavioral: TEEN HEEDAdolescent 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. |
| 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. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (8 listed)
- <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
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 |
|---|---|---|
| TEEN HEEDPeer-led workshops will cover behavioral skills including goal setting, self-monitoring, problem solving, contingency management, coping skills, and social support. | Behavioural | TEEN HEED |
Primary outcome
Change in body mass index (BMI)
Time frame: Baseline and 3 months
Change in BMI at post-intervention (approximately 3 months) as compared to baseline
Change in BMI
Time frame: Baseline and 1 year
Change in BMI at 1 year as compared to baseline
12 secondary outcomes
Change in fasting blood glucose levels
Time frame: Baseline and 3 months
Change in fasting blood glucose levels
Time frame: Baseline and 1 year
Change in post prandial blood glucose level
Time frame: Baseline and 3 months
Change in post prandial blood glucose level
Time frame: Baseline and 1 year
Change in blood pressure
Time frame: Baseline and 3 months
Change in blood pressure
Time frame: Baseline and 1 year
Change in percent body fat
Time frame: Baseline and 3 months
Change in percent body fat
Time frame: Baseline and 1 year
Change in waist circumference
Time frame: Baseline and 3 months
Change in waist circumference
Time frame: Baseline and 1 year
Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss
Time frame: Baseline and 3 months
Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss
Time frame: Baseline and 1 year
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 21 Nov 2019.
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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.
Nita Vangeepuram, MD, MPH principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEEN HEED in people with Pre-Diabetes, run by Icahn School of Medicine at Mount Sinai 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 8 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 21 Nov 2019. 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 body mass index (BMI) (time frame: Baseline and 3 months). The study lists 2 primary outcomes in all. 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 21 Nov 2019.