AzTrials
AzTrials

Pre-diabetesHEEDNCT01004848

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

A study testing Peer-Led Lifestyle Education on Weight Loss in people with Pre-diabetes, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pre-diabetes
What is being tested?
Peer-Led Lifestyle Education on Weight Loss
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
402 participants
Where
1 siteUnited States
Study dates
Mar 2009to Sep 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • < 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

Official title: Collaborations for Health Improvement in East Harlem-Project HEED

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.

Read the detailed description

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.

Conditions
Pre-diabetes
Being tested
Peer-Led Lifestyle Education on Weight Loss
Keywords
Pre-diabetes, pre-diabetic state, community-based participatory research, overweight, weight loss intervention, peer-led lifestyle education
Medical subject headings
Glucose Intolerance, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peer-Led Lifestyle Education on Weight LossBehavioural

    Also called Project HEED

    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.

Study groups in NCT01004848
Study groupRoleWhat they receive
Peer-Led Lifestyle Education on Weight LossExperimentalProject HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes. The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes.
Receives: Behavioral: Peer-Led Lifestyle Education on Weight Loss
Delayed InterventionPlacebo comparatorThe control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Receives: Behavioral: Peer-Led Lifestyle Education on Weight Loss

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Weight From Baseline to 6 Months

    Measured: Change from Baseline to 6 Months

Secondary outcomes (14)

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

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

    Measured: Change from Baseline to 6 Months

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

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

    Measured: Change in 6 Months from Baseline

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

    Measured: Change from Baseline to 6 Months

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

    Measured: Change from Baseline to 6 Months

  5. Waist Circumference

    Measured: Change from Baseline to 6 Months

  6. LDL Cholesterol

    Measured: Change from Baseline to 6 Months

  7. HDL Cholesterol

    Measured: Change from Baseline to 6 Months

  8. Total Cholesterol

    Measured: Change from Baseline to 6 Months

  9. Triglycerides

    Measured: Change from Baseline to 6 Months

  10. HbA1c

    Measured: Change from Baseline to 6 Months

  11. Energy Expenditure

    percent energy expenditure

    Measured: Change from Baseline to 6 Months

  12. Fiber Intake

    Measured: Change from Baseline to 6 Months

  13. Physical Activity (Self-report)

    Measured: 6 months

  14. Knowledge & Attitudes About Diabetes Risk

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionJul 2011
  4. Study completionSep 2012

Resources

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01004848
Sponsor's protocol ID
GCO 05-0463
Acronym
HEED
Status last verified
Oct 2014
First submitted
29 Oct 2009
Last updated
23 Oct 2014
Data monitoring committee
No

Publications

  • Goldfinger JZ, Arniella G, Wylie-Rosett J, Horowitz CR. Project HEAL: peer education leads to weight loss in Harlem. J Health Care Poor Underserved. 2008 Feb;19(1):180-92. doi: 10.1353/hpu.2008.0016.

    PubMed 18263994

  • Cowie CC, Rust KF, Ford ES, Eberhardt MS, Byrd-Holt DD, Li C, Williams DE, Gregg EW, Bainbridge KE, Saydah SH, Geiss LS. Full accounting of diabetes and pre-diabetes in the U.S. population in 1988-1994 and 2005-2006. Diabetes Care. 2009 Feb;32(2):287-94. doi: 10.2337/dc08-1296. Epub 2008 Nov 18.

    PubMed 19017771

  • Cowie CC, Rust KF, Byrd-Holt DD, Eberhardt MS, Flegal KM, Engelgau MM, Saydah SH, Williams DE, Geiss LS, Gregg EW. Prevalence of diabetes and impaired fasting glucose in adults in the U.S. population: National Health And Nutrition Examination Survey 1999-2002. Diabetes Care. 2006 Jun;29(6):1263-8. doi: 10.2337/dc06-0062.

    PubMed 16732006

  • Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.

    PubMed 11333990

  • Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.

    PubMed 11832527

  • Hamman RF, Wing RR, Edelstein SL, Lachin JM, Bray GA, Delahanty L, Hoskin M, Kriska AM, Mayer-Davis EJ, Pi-Sunyer X, Regensteiner J, Venditti B, Wylie-Rosett J. Effect of weight loss with lifestyle intervention on risk of diabetes. Diabetes Care. 2006 Sep;29(9):2102-7. doi: 10.2337/dc06-0560.

    PubMed 16936160

  • Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, Hu ZX, Lin J, Xiao JZ, Cao HB, Liu PA, Jiang XG, Jiang YY, Wang JP, Zheng H, Zhang H, Bennett PH, Howard BV. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care. 1997 Apr;20(4):537-44. doi: 10.2337/diacare.20.4.537.

    PubMed 9096977

  • Biuso TJ, Butterworth S, Linden A. A conceptual framework for targeting prediabetes with lifestyle, clinical, and behavioral management interventions. Dis Manag. 2007 Feb;10(1):6-15. doi: 10.1089/dis.2006.628.

    PubMed 17309360

  • Horowitz CR, Brenner BL, Lachapelle S, Amara DA, Arniella G. Effective recruitment of minority populations through community-led strategies. Am J Prev Med. 2009 Dec;37(6 Suppl 1):S195-200. doi: 10.1016/j.amepre.2009.08.006.

    PubMed 19896019

  • Fox AM, Mann DM, Ramos MA, Kleinman LC, Horowitz CR. Barriers to physical activity in East harlem, new york. J Obes. 2012;2012:719140. doi: 10.1155/2012/719140. Epub 2012 Jul 12.

    PubMed 22848797

  • Fei K, Fox A, Horowitz CR, Lee E. Family History and Perceptions of Control over Risk for Diabetes, SGIM Supplement 2012. PMC Journal - In Process.

  • Breland JY, Fox AM, Horowitz CR, Leventhal H. Applying a common-sense approach to fighting obesity. J Obes. 2012;2012:710427. doi: 10.1155/2012/710427. Epub 2012 Jun 28.

    PubMed 22811889

  • Parikh P, Simon EP, Fei K, Looker H, Goytia C, Horowitz CR. Results of a pilot diabetes prevention intervention in East Harlem, New York City: Project HEED. Am J Public Health. 2010 Apr 1;100 Suppl 1(Suppl 1):S232-9. doi: 10.2105/AJPH.2009.170910. Epub 2010 Feb 10.

    PubMed 20147680

Questions about this trial

What is this clinical trial studying?

A study testing Peer-Led Lifestyle Education on Weight Loss 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 5 inclusion and 9 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 23 Oct 2014. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 23 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Weight From Baseline to 6 Months (time frame: Change from Baseline to 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01004848, which also lists 13 linked publications.

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 23 Oct 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in