Trial Outcomes & Findings for Effectiveness Study of Community-Based, Peer-Led Education on Weight Loss and Diabetes (NCT NCT01004848)
NCT ID: NCT01004848
Last Updated: 2014-10-23
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
402 participants
Primary outcome timeframe
Change from Baseline to 6 Months
Results posted on
2014-10-23
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
210
|
192
|
|
Overall Study
COMPLETED
|
155
|
147
|
|
Overall Study
NOT COMPLETED
|
55
|
45
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
55
|
45
|
Baseline Characteristics
Effectiveness Study of Community-Based, Peer-Led Education on Weight Loss and Diabetes
Baseline characteristics by cohort
| Measure |
Peer-Led Lifestyle Education on Weight Loss
n=210 Participants
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
n=192 Participants
The control group offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
|
Total
n=402 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
186 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
356 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
178 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
343 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
153 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
294 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
52 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
155 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
299 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to 6 MonthsOutcome measures
| Measure |
Peer-Led Lifestyle Education on Weight Loss
n=155 Participants
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
n=147 Participants
The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
|
|---|---|---|
|
Change in Weight From Baseline to 6 Months
|
-2.85 pounds
Standard Deviation 7.42
|
-1.13 pounds
Standard Deviation 7.11
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 MonthsChange in sugar level as measured from fingerstick, at 6 Months as compared to Baseline
Outcome measures
| Measure |
Peer-Led Lifestyle Education on Weight Loss
n=155 Participants
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
n=147 Participants
The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
|
|---|---|---|
|
Change in Fasting Fingerstick Glucose Measurement From Baseline to 6 Months
|
-1.79 mg/dL
Standard Deviation 9.41
|
-0.47 mg/dL
Standard Deviation 9.98
|
SECONDARY outcome
Timeframe: Change in 6 Months from BaselineChange in sugar level as measured from fingerstick after a meal, at 6 Months as compared to Baseline
Outcome measures
| Measure |
Peer-Led Lifestyle Education on Weight Loss
n=155 Participants
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
n=147 Participants
The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
|
|---|---|---|
|
Change in Post-prandial Fingerstick Glucose From Baseline to 6 Months
|
1.41 mg/dL
Standard Deviation 26.59
|
3.85 mg/dL
Standard Deviation 33.14
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 MonthsOutcome measures
| Measure |
Peer-Led Lifestyle Education on Weight Loss
n=155 Participants
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
n=147 Participants
The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
|
|---|---|---|
|
Change in Systolic Blood Pressure From Baseline to 6 Months
|
-1.39 mmHg
Standard Deviation 11.84
|
-1.45 mmHg
Standard Deviation 12.77
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 MonthsOutcome measures
| Measure |
Peer-Led Lifestyle Education on Weight Loss
n=155 Participants
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
n=147 Participants
The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
|
|---|---|---|
|
Change in Diastolic Blood Pressure From Baseline to 6 Months
|
-0.47 mmHg
Standard Deviation 8.33
|
-1.07 mmHg
Standard Deviation 7.96
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 MonthsOutcome measures
| Measure |
Peer-Led Lifestyle Education on Weight Loss
n=155 Participants
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
n=147 Participants
The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
|
|---|---|---|
|
Waist Circumference
|
-0.5 inches
Standard Deviation 1.99
|
-0.29 inches
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 MonthsOutcome measures
| Measure |
Peer-Led Lifestyle Education on Weight Loss
n=155 Participants
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
n=147 Participants
The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
|
|---|---|---|
|
LDL Cholesterol
|
-2.93 mg/dl
Standard Deviation 18.17
|
-1.18 mg/dl
Standard Deviation 17.87
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 MonthsOutcome measures
| Measure |
Peer-Led Lifestyle Education on Weight Loss
n=155 Participants
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
n=147 Participants
The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
|
|---|---|---|
|
HDL Cholesterol
|
0.68 mg/dl
Standard Deviation 8.26
|
.029 mg/dl
Standard Deviation 7.17
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 MonthsOutcome measures
| Measure |
Peer-Led Lifestyle Education on Weight Loss
n=155 Participants
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
n=147 Participants
The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
|
|---|---|---|
|
Total Cholesterol
|
-2.78 mg/dl
Standard Deviation 21.37
|
-0.66 mg/dl
Standard Deviation 20.22
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 MonthsOutcome measures
| Measure |
Peer-Led Lifestyle Education on Weight Loss
n=155 Participants
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
n=147 Participants
The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
|
|---|---|---|
|
Triglycerides
|
-0.1 mg/dl
Standard Deviation 52.95
|
2.92 mg/dl
Standard Deviation 57.39
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 MonthsOutcome measures
| Measure |
Peer-Led Lifestyle Education on Weight Loss
n=155 Participants
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
n=147 Participants
The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
|
|---|---|---|
|
HbA1c
|
0.03 percent change
Standard Deviation 0.0485
|
1.20 percent change
Standard Deviation 0.0553
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 Monthspercent energy expenditure
Outcome measures
| Measure |
Peer-Led Lifestyle Education on Weight Loss
n=155 Participants
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
n=147 Participants
The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
|
|---|---|---|
|
Energy Expenditure
|
-58.08 percent expenditure/day
Standard Deviation 1.6429
|
-12.54 percent expenditure/day
Standard Deviation 0.6594
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 MonthsOutcome measures
| Measure |
Peer-Led Lifestyle Education on Weight Loss
n=155 Participants
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
n=147 Participants
The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
|
|---|---|---|
|
Fiber Intake
|
-0.19 grams per day
Standard Deviation 0.6377
|
0.013 grams per day
Standard Deviation 0.6594
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
Adverse Events
Peer-Led Lifestyle Education on Weight Loss
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Carol R. Horowitz, MD, MPH
Icahn School of Medicine at Mount Sinai
Phone: 212-659-9567
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place