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Completed

NCT Number: NCT01004848

Effectiveness Study of Community-Based, Peer-Led Education on Weight Loss and Diabetes

The purpose of this study is to compare the effectiveness of a peer-led community-based lifestyle intervention, versus usual care, in achieving weight loss and prevention of diabetes among overweight adults with pre-diabetes in East Harlem.

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Key information

Conditions

Pre-diabetes Body Weight Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

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

Weight loss can prevent diabetes and eliminate racial and ethnic disparities in incident diabetes among overweight adults with pre-diabetes. However, proven effective interventions have not been sustained or disseminated in community settings. A community-academic partnership aims to employ community-based participatory research to conduct a randomized controlled trial to test the effectiveness of a culturally tailored, peer-led diabetes prevention intervention that promotes weight loss.

People who develop diabetes go through a period when they have "pre-diabetes". In clinical settings, overweight adults with pre-diabetes who reduce their weight by 5-10% can reduce their risk of developing diabetes by 55-60%. To date, there are no studies testing the effectiveness of peer-led, community-based programs in achieving diabetes prevention through weight loss.

We will identify and enroll 400 overweight (BMI > 25) adults with pre-diabetes in East Harlem and randomized half into a community-based, peer-led lifestyle education program that teaches simple ways to lose weight.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years of age and older
  • Residents of East Harlem or members of an East Harlem Institution in zip codes 10029, 10035, OR in the section of 10037 east of Fifth Avenue
  • BMI ≥ 25 AND pre-diabetes glucose values, defined as fasting fingerstick glucose of 100-125mg/dl and/or glucose 2 hours after an oral glucose load of 140-199 mg/dl
  • Able to communicate verbally to participate in a group education class
  • English or Spanish speaking

Exclusion criteria

  • < 18 years
  • Previous diagnosis of diabetes
  • BMI <25
  • Fingerstick glucoses outside pre-diabetes level ranges
  • Currently pregnant
  • On medications that may raise or lower blood glucose
  • Cognitive or physical impairment that would preclude comprehension of a conversation and communicating as part of a group (i.e., dementia, deafness, inability to speak)
  • Self-reported terminal illness with life expectancy of less than 1 year
  • Plans to relocate from New York City within one year of enrollment

Treatment and study plan

Peer-Led Lifestyle Education on Weight Loss

Behavioral

Project HEED (Help Educate to Eliminate Diabetes) is a bilingual lifestyle education program written at a 4th grade reading level, and contains simple, actionable, messages, is easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes. It consists of 8 sessions (1½ hours each) held over 10-weeks. Topics include diabetes prevention, finding and affording healthy foods, label reading, fun physical activity, planning a healthy plate, making traditional foods healthy, and portion control.

Other names: Project HEED

Primary outcomes

  1. Change in Weight From Baseline to 6 Months

    Time frame: Change from Baseline to 6 Months

Secondary outcomes

  1. Change in Fasting Fingerstick Glucose Measurement From Baseline to 6 Months

    Time frame: Change from Baseline to 6 Months

    Change in sugar level as measured from fingerstick, at 6 Months as compared to Baseline

  2. Change in Post-prandial Fingerstick Glucose From Baseline to 6 Months

    Time frame: Change in 6 Months from Baseline

    Change in sugar level as measured from fingerstick after a meal, at 6 Months as compared to Baseline

  3. Change in Systolic Blood Pressure From Baseline to 6 Months

    Time frame: Change from Baseline to 6 Months

  4. Change in Diastolic Blood Pressure From Baseline to 6 Months

    Time frame: Change from Baseline to 6 Months

  5. Waist Circumference

    Time frame: Change from Baseline to 6 Months

  6. LDL Cholesterol

    Time frame: Change from Baseline to 6 Months

  7. HDL Cholesterol

    Time frame: Change from Baseline to 6 Months

  8. Total Cholesterol

    Time frame: Change from Baseline to 6 Months

  9. Triglycerides

    Time frame: Change from Baseline to 6 Months

  10. HbA1c

    Time frame: Change from Baseline to 6 Months

  11. Energy Expenditure

    Time frame: Change from Baseline to 6 Months

    percent energy expenditure

  12. Fiber Intake

    Time frame: Change from Baseline to 6 Months

  13. Physical Activity (Self-report)

    Time frame: 6 months

  14. Knowledge & Attitudes About Diabetes Risk

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Albert Einstein College of Medicine
  • North General Hospital, New York
  • Union Settlement Association, New York

Registry information

Official study title

Collaborations for Health Improvement in East Harlem-Project HEED

Acronym: HEED

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Oct 30, 2009
Registry last updated
Oct 23, 2014

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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