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

This study has been completed.
Sponsor:
Collaborators:
North General Hospital, New York
Albert Einstein College of Medicine of Yeshiva University
Union Settlement Association, New York
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01004848
First received: October 29, 2009
Last updated: October 22, 2014
Last verified: October 2014
Results First Received: September 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Pre-diabetes
Intervention: Behavioral: Peer-Led Lifestyle Education on Weight Loss

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Peer-Led Lifestyle Education on Weight Loss

Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.

The intervention group participated 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.

Delayed Intervention The control group was be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.

Participant Flow:   Overall Study
    Peer-Led Lifestyle Education on Weight Loss     Delayed Intervention  
STARTED     210     192  
COMPLETED     155     147  
NOT COMPLETED     55     45  
Lost to Follow-up                 55                 45  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Peer-Led Lifestyle Education on Weight Loss

Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.

The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aimed to help participants lose weight, thereby preventing their progression to diabetes.

Delayed Intervention The control group offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Total Total of all reporting groups

Baseline Measures
    Peer-Led Lifestyle Education on Weight Loss     Delayed Intervention     Total  
Number of Participants  
[units: participants]
  210     192     402  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     186     170     356  
>=65 years     24     22     46  
Gender  
[units: participants]
     
Female     178     165     343  
Male     32     27     59  
Ethnicity (NIH/OMB)  
[units: participant]
     
Hispanic or Latino     153     141     294  
Not Hispanic or Latino     55     48     103  
Unknown or Not Reported     2     3     5  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     2     2  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     52     41     93  
White     0     3     3  
More than one race     3     2     5  
Unknown or Not Reported     155     144     299  



  Outcome Measures
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1.  Primary:   Change in Weight From Baseline to 6 Months   [ Time Frame: Change from Baseline to 6 Months ]

2.  Secondary:   Change in Fasting Fingerstick Glucose Measurement From Baseline to 6 Months   [ Time Frame: Change from Baseline to 6 Months ]

3.  Secondary:   Change in Post-prandial Fingerstick Glucose From Baseline to 6 Months   [ Time Frame: Change in 6 Months from Baseline ]

4.  Secondary:   Change in Systolic Blood Pressure From Baseline to 6 Months   [ Time Frame: Change from Baseline to 6 Months ]

5.  Secondary:   Change in Diastolic Blood Pressure From Baseline to 6 Months   [ Time Frame: Change from Baseline to 6 Months ]

6.  Secondary:   Waist Circumference   [ Time Frame: Change from Baseline to 6 Months ]

7.  Secondary:   LDL Cholesterol   [ Time Frame: Change from Baseline to 6 Months ]

8.  Secondary:   HDL Cholesterol   [ Time Frame: Change from Baseline to 6 Months ]

9.  Secondary:   Total Cholesterol   [ Time Frame: Change from Baseline to 6 Months ]

10.  Secondary:   Triglycerides   [ Time Frame: Change from Baseline to 6 Months ]

11.  Secondary:   HbA1c   [ Time Frame: Change from Baseline to 6 Months ]

12.  Secondary:   Energy Expenditure   [ Time Frame: Change from Baseline to 6 Months ]

13.  Secondary:   Fiber Intake   [ Time Frame: Change from Baseline to 6 Months ]

14.  Secondary:   Physical Activity (Self-report)   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

15.  Secondary:   Knowledge & Attitudes About Diabetes Risk   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Carol R. Horowitz, MD, MPH
Organization: Icahn School of Medicine at Mount Sinai
phone: 212-659-9567
e-mail: carol.horowitz@mountsinai.org


Publications of Results:
Other Publications:


Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01004848     History of Changes
Other Study ID Numbers: GCO 05-0463
Study First Received: October 29, 2009
Results First Received: September 4, 2013
Last Updated: October 22, 2014
Health Authority: United States: Institutional Review Board