N/A
N=51
Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study
Pre-diabetes · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02835495 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Recruitment of Study Participants — 58; 51 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HELP Vets Intervention (Behavioral); Individual Education Program (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment of Study Participants |
58; 51 | — |
| PRIMARY Retention of Study Participants |
21; 23 | — |
| PRIMARY Adherence to the Lifestyle Weight Loss Intervention |
14 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02835495). 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.