- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02835495
Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study (HELP Vets)
The Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Type II diabetes and its complications disproportionately affect the patient population served by the Department of Veterans Affairs (VA). Recent lifestyle interventions have demonstrated that weight-loss achieved through reductions in calorie intake and increases in physical activity can prevent or delay the onset of diabetes. The Healthy Living Partnerships to Prevent Diabetes (HELP PD), a community-based adaptation of the lifestyle intervention used in the Diabetes Prevention Program, achieved more than a 7% weight loss at 6 months.
In HELP Vets, researchers will test the feasibility of further translating the HELP PD lifestyle intervention, tailored for use in the Veteran population, in the Kernersville Community-Based Outpatient Clinic operated by the VA. The investigators plan to recruit 50 overweight or obese Veterans at high risk for developing diabetes from the existing patient population to participate in a 6-month weight loss intervention led by community health workers who are also Veterans. As VA outpatient clinics have the requisite infrastructure to identify, screen, and enroll participants and access to Veteran community health workers from within their patient populations, they are ideal potential homes for diabetes prevention programming. Data gathered during this planning grant will be used to develop a large-scale study to test implementing the HELP Vets intervention in a larger segment of the Veteran population.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Salisbury, North Carolina, United States, 28144
- W.G. "Bill" Hefner VA Medical Center
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI 25-40 kg/m2
- Evidence of Pre-Diabetes: all participants will be required to qualify based on evidence of prediabetes from fasting plasma glucose, oral glucose tolerance test, or hemoglobin A1c (HbA1c) taken in the three months.
- The appropriate ranges for each test are
- Hemoglobin A1c (HbAlc): 5.7 to 6.4%
- Fasting Plasma Glucose: 95-125 mg/dL
- Oral Glucose Tolerance Test: 140-200 mg/dL.
- Blood measures will be collected from the medical record
- Prospective participants must be willing to accept randomization to either the lifestyle intervention or the enhanced usual care condition.
Exclusion Criteria:
- Currently involved in a supervised program for weight loss
- Clinical history of diabetes
- Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, transient ischemic attack (TIA), carotid revascularization, peripheral arterial disease, and congestive heart failure
- Uncontrolled high blood pressure (BP > 160/100) Potential participants can be re-screened after controlled
- Pregnancy, planning pregnancy and breast feeding (self-report) during screening; Other chronic disease likely to limit lifespan to less than 2-3 years, including any cancer requiring treatment in past 5 years except non-melanoma skin cancer
- Chronic use of medicine known to significantly affect glucose metabolism (e.g., corticosteroids, protease inhibitors)
- Other conditions/criteria likely to interfere with participation and acceptance of randomized assignment, including the following: inability/unwillingness to give informed consent, another household member already randomized to HELP Vets, major psychiatric or cognitive problems (schizophrenia, dementia, self-reported active illegal substance or alcohol abuse), participation in another research study that would interfere with HELP Vets.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lifestyle Weight Loss
Behavioral: HELP Vets Intervention Lifestyle intervention consisting of 24 weekly group meetings led by a Veteran community health worker and 3 individual sessions with a nutritionist/diabetes educator |
This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity.
The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%.
The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.
|
Active Comparator: Enhanced Usual Care
Behavioral: Individual Education Program Standard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter |
Participants will receive two individual sessions with a nutritionist during the first 3 months.
In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss.
These participants will also receive a monthly newsletter on topics related to healthy lifestyle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment of Study Participants
Time Frame: 6 months
|
To characterize the ability to recruit Veterans to participate in this pilot study, the proportion of Veterans screened who are eligible to participate and the proportion of eligible participants who agree to participate will be calculated.
The rate of referrals to the program by providers in the local community-based outpatient clinic will also be monitored.
|
6 months
|
Retention of Study Participants
Time Frame: 6 months
|
To characterize the ability to retain Veterans in this pilot study, the percentage of participants who complete the study (attendance at the 6-month assessment visit) as a measure of overall study retention will be calculated.
|
6 months
|
Adherence to the Lifestyle Weight Loss Intervention
Time Frame: 6 months
|
The proportion of intervention sessions attended will be calculated.
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: 6 months
|
The means and standard deviations at 6 months will be calculated.
|
6 months
|
Systolic Blood Pressure
Time Frame: 6 months
|
The means and standard deviations at 6 months will be calculated.
|
6 months
|
Diastolic Blood Pressure
Time Frame: 6 months
|
The means and standard deviations at 6 months will be calculated.
|
6 months
|
Proportion of Participants for Whom Fasting Glucose is Available at 6-months Post-randomization
Time Frame: 6 months
|
In order to assess the feasibility of collecting this data from the medical record, the proportion of participants for whom this data is available at 6-months post-randomization (+/- 90 days) will be reported.
|
6 months
|
Proportion of Participants for Whom Cholesterol (Lipid Panel) is Available at 6-months Post-randomization
Time Frame: 6 months
|
In order to assess the feasibility of collecting this data from the medical record, the proportion of participants for whom this data is available at 6-months post-randomization (+/- 90 days) will be reported.
|
6 months
|
Fasting Glucose
Time Frame: 6 months
|
The means and standard deviations at 6 months will be calculated.
|
6 months
|
Cholesterol (Lipid Panel)
Time Frame: 6 months
|
The means and standard deviations at 6 months will be calculated.
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00033688
- R34DK108100 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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