N/A
Completed N=402
Effectiveness Study of Community-Based, Peer-Led Education on Weight Loss and Diabetes
Pre-diabetes
Source: ClinicalTrials.gov NCT01004848 ↗
Enrolled (actual)
402
Serious AEs
—
Results posted
Oct 2014
Primary outcomePrimary: Change in Weight From Baseline to 6 Months — -2.85; -1.13 pounds
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weight From Baseline to 6 Months |
-2.85; -1.13 | — |
| SECONDARY Change in Fasting Fingerstick Glucose Measurement From Baseline to 6 Months |
-1.79; -0.47 | — |
| SECONDARY Change in Post-prandial Fingerstick Glucose From Baseline to 6 Months |
1.41; 3.85 | — |
| SECONDARY Change in Systolic Blood Pressure From Baseline to 6 Months |
-1.39; -1.45 | — |
| SECONDARY Change in Diastolic Blood Pressure From Baseline to 6 Months |
-0.47; -1.07 | — |
| SECONDARY Waist Circumference |
-0.5; -0.29 | — |
| SECONDARY LDL Cholesterol |
-2.93; -1.18 | — |
| SECONDARY HDL Cholesterol |
0.68; .029 | — |
| SECONDARY Total Cholesterol |
-2.78; -0.66 | — |
| SECONDARY Triglycerides |
-0.1; 2.92 | — |
| SECONDARY HbA1c |
0.03; 1.20 | — |
| SECONDARY Energy Expenditure |
-58.08; -12.54 | — |
| SECONDARY Fiber Intake |
-0.19; 0.013 | — |
| SECONDARY Physical Activity (Self-report) |
— | — |
| SECONDARY Knowledge & Attitudes About Diabetes Risk |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01004848). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.