Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01004848
Recruitment Status : Completed
First Posted : October 30, 2009
Results First Posted : October 23, 2014
Last Update Posted : October 23, 2014
Sponsor:
Collaborators:
North General Hospital, New York
Albert Einstein College of Medicine
Union Settlement Association, New York
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Pre-diabetes
Intervention Behavioral: Peer-Led Lifestyle Education on Weight Loss
Enrollment 402
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Peer-Led Lifestyle Education on Weight Loss Delayed Intervention
Hide Arm/Group Description

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.

The control group was be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Period Title: Overall Study
Started 210 192
Completed 155 147
Not Completed 55 45
Reason Not Completed
Lost to Follow-up             55             45
Arm/Group Title Peer-Led Lifestyle Education on Weight Loss Delayed Intervention Total
Hide Arm/Group Description

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.

The control group offered the chance to participate in the 8-session course 1 year after enrollment into the trial. Total of all reporting groups
Overall Number of Baseline Participants 210 192 402
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants 192 participants 402 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
186
  88.6%
170
  88.5%
356
  88.6%
>=65 years
24
  11.4%
22
  11.5%
46
  11.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants 192 participants 402 participants
Female
178
  84.8%
165
  85.9%
343
  85.3%
Male
32
  15.2%
27
  14.1%
59
  14.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants 192 participants 402 participants
Hispanic or Latino
153
  72.9%
141
  73.4%
294
  73.1%
Not Hispanic or Latino
55
  26.2%
48
  25.0%
103
  25.6%
Unknown or Not Reported
2
   1.0%
3
   1.6%
5
   1.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants 192 participants 402 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
2
   1.0%
2
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
52
  24.8%
41
  21.4%
93
  23.1%
White
0
   0.0%
3
   1.6%
3
   0.7%
More than one race
3
   1.4%
2
   1.0%
5
   1.2%
Unknown or Not Reported
155
  73.8%
144
  75.0%
299
  74.4%
1.Primary Outcome
Title Change in Weight From Baseline to 6 Months
Hide Description [Not Specified]
Time Frame Change from Baseline to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peer-Led Lifestyle Education on Weight Loss Delayed Intervention
Hide Arm/Group Description:

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.

The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Overall Number of Participants Analyzed 155 147
Mean (Standard Deviation)
Unit of Measure: pounds
-2.85  (7.42) -1.13  (7.11)
2.Secondary Outcome
Title Change in Fasting Fingerstick Glucose Measurement From Baseline to 6 Months
Hide Description Change in sugar level as measured from fingerstick, at 6 Months as compared to Baseline
Time Frame Change from Baseline to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peer-Led Lifestyle Education on Weight Loss Delayed Intervention
Hide Arm/Group Description:

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.

The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Overall Number of Participants Analyzed 155 147
Mean (Standard Deviation)
Unit of Measure: mg/dL
-1.79  (9.41) -0.47  (9.98)
3.Secondary Outcome
Title Change in Post-prandial Fingerstick Glucose From Baseline to 6 Months
Hide Description Change in sugar level as measured from fingerstick after a meal, at 6 Months as compared to Baseline
Time Frame Change in 6 Months from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peer-Led Lifestyle Education on Weight Loss Delayed Intervention
Hide Arm/Group Description:

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.

The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Overall Number of Participants Analyzed 155 147
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.41  (26.59) 3.85  (33.14)
4.Secondary Outcome
Title Change in Systolic Blood Pressure From Baseline to 6 Months
Hide Description [Not Specified]
Time Frame Change from Baseline to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peer-Led Lifestyle Education on Weight Loss Delayed Intervention
Hide Arm/Group Description:

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.

The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Overall Number of Participants Analyzed 155 147
Mean (Standard Deviation)
Unit of Measure: mmHg
-1.39  (11.84) -1.45  (12.77)
5.Secondary Outcome
Title Change in Diastolic Blood Pressure From Baseline to 6 Months
Hide Description [Not Specified]
Time Frame Change from Baseline to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peer-Led Lifestyle Education on Weight Loss Delayed Intervention
Hide Arm/Group Description:

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.

The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Overall Number of Participants Analyzed 155 147
Mean (Standard Deviation)
Unit of Measure: mmHg
-0.47  (8.33) -1.07  (7.96)
6.Secondary Outcome
Title Waist Circumference
Hide Description [Not Specified]
Time Frame Change from Baseline to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peer-Led Lifestyle Education on Weight Loss Delayed Intervention
Hide Arm/Group Description:

Project 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.

The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Overall Number of Participants Analyzed 155 147
Mean (Standard Deviation)
Unit of Measure: inches
-0.5  (1.99) -0.29  (2.06)
7.Secondary Outcome
Title LDL Cholesterol
Hide Description [Not Specified]
Time Frame Change from Baseline to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peer-Led Lifestyle Education on Weight Loss Delayed Intervention
Hide Arm/Group Description:

Project 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.

The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Overall Number of Participants Analyzed 155 147
Mean (Standard Deviation)
Unit of Measure: mg/dl
-2.93  (18.17) -1.18  (17.87)
8.Secondary Outcome
Title HDL Cholesterol
Hide Description [Not Specified]
Time Frame Change from Baseline to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peer-Led Lifestyle Education on Weight Loss Delayed Intervention
Hide Arm/Group Description:

Project 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.

The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Overall Number of Participants Analyzed 155 147
Mean (Standard Deviation)
Unit of Measure: mg/dl
0.68  (8.26) .029  (7.17)
9.Secondary Outcome
Title Total Cholesterol
Hide Description [Not Specified]
Time Frame Change from Baseline to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peer-Led Lifestyle Education on Weight Loss Delayed Intervention
Hide Arm/Group Description:

Project 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.

The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Overall Number of Participants Analyzed 155 147
Mean (Standard Deviation)
Unit of Measure: mg/dl
-2.78  (21.37) -0.66  (20.22)
10.Secondary Outcome
Title Triglycerides
Hide Description [Not Specified]
Time Frame Change from Baseline to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peer-Led Lifestyle Education on Weight Loss Delayed Intervention
Hide Arm/Group Description:

Project 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.

The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Overall Number of Participants Analyzed 155 147
Mean (Standard Deviation)
Unit of Measure: mg/dl
-0.1  (52.95) 2.92  (57.39)
11.Secondary Outcome
Title HbA1c
Hide Description [Not Specified]
Time Frame Change from Baseline to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peer-Led Lifestyle Education on Weight Loss Delayed Intervention
Hide Arm/Group Description:

Project 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.

The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Overall Number of Participants Analyzed 155 147
Mean (Standard Deviation)
Unit of Measure: percent change
0.03  (0.0485) 1.20  (0.0553)
12.Secondary Outcome
Title Energy Expenditure
Hide Description percent energy expenditure
Time Frame Change from Baseline to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peer-Led Lifestyle Education on Weight Loss Delayed Intervention
Hide Arm/Group Description:

Project 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.

The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Overall Number of Participants Analyzed 155 147
Mean (Standard Deviation)
Unit of Measure: percent expenditure/day
-58.08  (1.6429) -12.54  (0.6594)
13.Secondary Outcome
Title Fiber Intake
Hide Description [Not Specified]
Time Frame Change from Baseline to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peer-Led Lifestyle Education on Weight Loss Delayed Intervention
Hide Arm/Group Description:

Project 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.

The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Overall Number of Participants Analyzed 155 147
Mean (Standard Deviation)
Unit of Measure: grams per day
-0.19  (0.6377) 0.013  (0.6594)
14.Secondary Outcome
Title Physical Activity (Self-report)
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Knowledge & Attitudes About Diabetes Risk
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description not applicable - adverse events not collected
 
Arm/Group Title Peer-Led Lifestyle Education on Weight Loss Delayed Intervention
Hide Arm/Group Description

Project 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.

The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
All-Cause Mortality
Peer-Led Lifestyle Education on Weight Loss Delayed Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Peer-Led Lifestyle Education on Weight Loss Delayed Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Peer-Led Lifestyle Education on Weight Loss Delayed Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Carol R. Horowitz, MD, MPH
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-659-9567
EMail: carol.horowitz@mountsinai.org
Other Publications:
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.
Layout table for additonal information
Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01004848     History of Changes
Other Study ID Numbers: GCO 05-0463
First Submitted: October 29, 2009
First Posted: October 30, 2009
Results First Submitted: September 4, 2013
Results First Posted: October 23, 2014
Last Update Posted: October 23, 2014