Clinical trial NCT02835495: Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study
Official title: The Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetes
Obesity
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: US Department of Veterans Affairs
First posted: 2016-07-18
Enrollment: 118
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Diabetes and obesity are both major public health concerns and the prevalence of diabetes is even higher in the patient population of the Veterans Administration. This planning project is designed to adapt a successful weight-loss program for delivery through an existing outpatient clinic to reach local Veterans at risk for developing diabetes. The information gathered as a part of this project will be used to plan a larger trial designed to improve the health of Veterans by offering them a diabetes prevention program through their usual source of healthcare.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment of Study Participants
timeFrame: 6 months
measure: Retention of Study Participants
timeFrame: 6 months
measure: Adherence to the Lifestyle Weight Loss Intervention
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Weight
timeFrame: 6 months
measure: Systolic Blood Pressure
timeFrame: 6 months
measure: Diastolic Blood Pressure
timeFrame: 6 months
measure: Proportion of Participants for Whom Fasting Glucose is Available at 6-months Post-randomization
timeFrame: 6 months
measure: Proportion of Participants for Whom Cholesterol (Lipid Panel) is Available at 6-months Post-randomization
timeFrame: 6 months
measure: Fasting Glucose
timeFrame: 6 months
measure: Cholesterol (Lipid Panel)
timeFrame: 6 months
Locations:
city: Salisbury
country: United States
facility: W.G. "Bill" Hefner VA Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Mara Z Vitolins, DrPH MPH RDN
role: PRINCIPAL_INVESTIGATOR
References: