Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study

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.

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 (HbA1c) taken in the three months.

- The appropriate ranges for each test are

- 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, 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.