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Completed

NCT Number: NCT02458131

Community-based Adolescent Diabetes Prevention Program

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.

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Key information

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.
  • 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

Treatment and study plan

TEEN HEED

Behavioral

Peer-led workshops will cover behavioral skills including goal setting, self-monitoring, problem solving, contingency management, coping skills, and social support.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

TEEN HEED: An Adolescent Peer Led Diabetes Prevention Intervention

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 29, 2015
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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