Pre-diabetes
Conditions
Keywords
Pre-diabetes, pre-diabetic state, community-based participatory research, overweight, weight loss intervention, peer-led lifestyle education
Brief 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.
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.
Interventions
BEHAVIORALPeer-Led Lifestyle Education on Weight Loss
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.
Sponsors
North General Hospital, New York
Albert Einstein College of Medicine
Union Settlement Association, New York
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Weight From Baseline to 6 Months | Change from Baseline to 6 Months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Triglycerides | Change from Baseline to 6 Months | — |
| HbA1c | Change from Baseline to 6 Months | — |
| Energy Expenditure | Change from Baseline to 6 Months | percent energy expenditure |
| Fiber Intake | Change from Baseline to 6 Months | — |
| Physical Activity (Self-report) | 6 months | — |
| Knowledge & Attitudes About Diabetes Risk | 6 months | — |
| Total Cholesterol | Change from Baseline to 6 Months | — |
| Change in Post-prandial Fingerstick Glucose From Baseline to 6 Months | Change in 6 Months from Baseline | Change in sugar level as measured from fingerstick after a meal, at 6 Months as compared to Baseline |
| Change in Systolic Blood Pressure From Baseline to 6 Months | Change from Baseline to 6 Months | — |
| Change in Diastolic Blood Pressure From Baseline to 6 Months | Change from Baseline to 6 Months | — |
| Waist Circumference | Change from Baseline to 6 Months | — |
| LDL Cholesterol | Change from Baseline to 6 Months | — |
| HDL Cholesterol | Change from Baseline to 6 Months | — |
| Change in Fasting Fingerstick Glucose Measurement From Baseline to 6 Months | Change from Baseline to 6 Months | Change in sugar level as measured from fingerstick, at 6 Months as compared to Baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 210 |
| Delayed Intervention The control group offered the chance to participate in the 8-session course 1 year after enrollment into the trial. | 192 |
| Total | 402 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 55 | 45 |
Baseline characteristics
| Characteristic | Peer-Led Lifestyle Education on Weight Loss | Delayed Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 24 Participants | 22 Participants | 46 Participants |
| Age, Categorical Between 18 and 65 years | 186 Participants | 170 Participants | 356 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 153 Participants | 141 Participants | 294 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants | 48 Participants | 103 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 52 Participants | 41 Participants | 93 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 155 Participants | 144 Participants | 299 Participants |
| Race (NIH/OMB) White | 0 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Female | 178 Participants | 165 Participants | 343 Participants |
| Sex: Female, Male Male | 32 Participants | 27 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in Weight From Baseline to 6 Months
Time frame: Change from Baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-Led Lifestyle Education on Weight Loss | Change in Weight From Baseline to 6 Months | -2.85 pounds | Standard Deviation 7.42 |
| Delayed Intervention | Change in Weight From Baseline to 6 Months | -1.13 pounds | Standard Deviation 7.11 |
Secondary
Change in Diastolic Blood Pressure From Baseline to 6 Months
Time frame: Change from Baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-Led Lifestyle Education on Weight Loss | Change in Diastolic Blood Pressure From Baseline to 6 Months | -0.47 mmHg | Standard Deviation 8.33 |
| Delayed Intervention | Change in Diastolic Blood Pressure From Baseline to 6 Months | -1.07 mmHg | Standard Deviation 7.96 |
Secondary
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
Time frame: Change from Baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-Led Lifestyle Education on Weight Loss | Change in Fasting Fingerstick Glucose Measurement From Baseline to 6 Months | -1.79 mg/dL | Standard Deviation 9.41 |
| Delayed Intervention | Change in Fasting Fingerstick Glucose Measurement From Baseline to 6 Months | -0.47 mg/dL | Standard Deviation 9.98 |
Secondary
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
Time frame: Change in 6 Months from Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-Led Lifestyle Education on Weight Loss | Change in Post-prandial Fingerstick Glucose From Baseline to 6 Months | 1.41 mg/dL | Standard Deviation 26.59 |
| Delayed Intervention | Change in Post-prandial Fingerstick Glucose From Baseline to 6 Months | 3.85 mg/dL | Standard Deviation 33.14 |
Secondary
Change in Systolic Blood Pressure From Baseline to 6 Months
Time frame: Change from Baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-Led Lifestyle Education on Weight Loss | Change in Systolic Blood Pressure From Baseline to 6 Months | -1.39 mmHg | Standard Deviation 11.84 |
| Delayed Intervention | Change in Systolic Blood Pressure From Baseline to 6 Months | -1.45 mmHg | Standard Deviation 12.77 |
Secondary
Energy Expenditure
percent energy expenditure
Time frame: Change from Baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-Led Lifestyle Education on Weight Loss | Energy Expenditure | -58.08 percent expenditure/day | Standard Deviation 1.6429 |
| Delayed Intervention | Energy Expenditure | -12.54 percent expenditure/day | Standard Deviation 0.6594 |
Secondary
Fiber Intake
Time frame: Change from Baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-Led Lifestyle Education on Weight Loss | Fiber Intake | -0.19 grams per day | Standard Deviation 0.6377 |
| Delayed Intervention | Fiber Intake | 0.013 grams per day | Standard Deviation 0.6594 |
Secondary
HbA1c
Time frame: Change from Baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-Led Lifestyle Education on Weight Loss | HbA1c | 0.03 percent change | Standard Deviation 0.0485 |
| Delayed Intervention | HbA1c | 1.20 percent change | Standard Deviation 0.0553 |
Secondary
HDL Cholesterol
Time frame: Change from Baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-Led Lifestyle Education on Weight Loss | HDL Cholesterol | 0.68 mg/dl | Standard Deviation 8.26 |
| Delayed Intervention | HDL Cholesterol | .029 mg/dl | Standard Deviation 7.17 |
Secondary
Knowledge & Attitudes About Diabetes Risk
Time frame: 6 months
Secondary
LDL Cholesterol
Time frame: Change from Baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-Led Lifestyle Education on Weight Loss | LDL Cholesterol | -2.93 mg/dl | Standard Deviation 18.17 |
| Delayed Intervention | LDL Cholesterol | -1.18 mg/dl | Standard Deviation 17.87 |
Secondary
Physical Activity (Self-report)
Time frame: 6 months
Secondary
Total Cholesterol
Time frame: Change from Baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-Led Lifestyle Education on Weight Loss | Total Cholesterol | -2.78 mg/dl | Standard Deviation 21.37 |
| Delayed Intervention | Total Cholesterol | -0.66 mg/dl | Standard Deviation 20.22 |
Secondary
Triglycerides
Time frame: Change from Baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-Led Lifestyle Education on Weight Loss | Triglycerides | -0.1 mg/dl | Standard Deviation 52.95 |
| Delayed Intervention | Triglycerides | 2.92 mg/dl | Standard Deviation 57.39 |
Secondary
Waist Circumference
Time frame: Change from Baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-Led Lifestyle Education on Weight Loss | Waist Circumference | -0.5 inches | Standard Deviation 1.99 |
| Delayed Intervention | Waist Circumference | -0.29 inches | Standard Deviation 2.06 |