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Trial record 25 of 88 for:    NIDDK endocrine and diabetes | Recruiting, Not yet recruiting, Available Studies

Community-based Adolescent Diabetes Prevention Program

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ClinicalTrials.gov Identifier: NCT02458131
Recruitment Status : Recruiting
First Posted : May 29, 2015
Last Update Posted : February 6, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Pre-Diabetes Behavioral: TEEN HEED Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: TEEN HEED: An Adolescent Peer Led Diabetes Prevention Intervention
Actual Study Start Date : November 11, 2016
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : September 15, 2019

Arm Intervention/treatment
Experimental: TEEN HEED
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
Peer-led workshops will cover behavioral skills including goal setting, self-monitoring, problem solving, contingency management, coping skills, and social support.

No Intervention: Wait List Control
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.



Primary Outcome Measures :
  1. 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

  2. Change in BMI [ Time Frame: Baseline and 1 year ]
    Change in BMI at 1 year as compared to baseline


Secondary Outcome Measures :
  1. Change in fasting blood glucose levels [ Time Frame: Baseline and 3 months ]
    Change in fasting blood glucose levels at post-intervention (approximately 3 months) as compared to baseline

  2. Change in fasting blood glucose levels [ Time Frame: Baseline and 1 year ]
    Change in fasting blood glucose levels at 1 year as compared to baseline

  3. Change in post prandial blood glucose level [ Time Frame: Baseline and 3 months ]
    Change in post prandial blood glucose level at post-intervention (approximately 3 months) as compared to baseline

  4. Change in post prandial blood glucose level [ Time Frame: Baseline and 1 year ]
    Change in post prandial blood glucose level at 1 year as compared to baseline

  5. Change in blood pressure [ Time Frame: Baseline and 3 months ]
    Change in blood pressure at post-intervention (approximately 3 months) as compared to baseline

  6. Change in blood pressure [ Time Frame: Baseline and 1 year ]
    Change in blood pressure at 1 year as compared to baseline

  7. Change in percent body fat [ Time Frame: Baseline and 3 months ]
    Change in percent body fat at post-intervention (approximately 3 months) as compared to baseline

  8. Change in percent body fat [ Time Frame: Baseline and 1 year ]
    Change in percent body fat at 1 year as compared to baseline

  9. Change in waist circumference [ Time Frame: Baseline and 3 months ]
    Change in waist circumference at post-intervention (approximately 3 months) as compared to baseline

  10. Change in waist circumference [ Time Frame: Baseline and 1 year ]
    Change in waist circumference at 1 year as compared to baseline

  11. 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 (from the TEEN HEED survey) at post-intervention (approximately 3 months) as compared to baseline

  12. Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss [ Time Frame: Baseline and 1 year ]
    Change in knowledge, attitudes, beliefs and behaviors (from the TEEN HEED survey) at 1 year as compared to baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for pre-diabetes screening:

  • 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:

    1. attending a school in East Harlem
    2. attending an after school or recreational activity in East Harlem
    3. 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

Note: additional inclusion criteria for participation in workshops include diagnosis of pre-diabetes based on oral glucose tolerance test

Exclusion Criteria for pre-diabetes screening:

  • <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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02458131


Contacts
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Contact: Nita Vangeepuram, MD, MPH 917-478-2106 Nita.Vangeepuram@mssm.edu

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Nita Vangeepuram, MD, MPH       Nita.Vangeepuram@mssm.edu   
Principal Investigator: Nita Vangeepuram, MD, MPH         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Nita Vangeepuram, MD, MPH Icahn School of Medicine at Mount Sinai

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02458131     History of Changes
Other Study ID Numbers: GCO 13-0901
5K23DK101692-02 ( U.S. NIH Grant/Contract )
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Keywords provided by Icahn School of Medicine at Mount Sinai:
community-based participatory research
adolescents
Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases