Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study

NCT ID: NCT02835495

Last Updated: 2020-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-15
• Study Completion Date: 2019-08-30

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.

Conditions

Pre-diabetes; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

HELP Vets Intervention

Intervention Type: BEHAVIORAL

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.

Enhanced Usual Care

Behavioral: Individual Education Program

Standard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter

Group Type: ACTIVE_COMPARATOR

Individual Education Program

Intervention Type: BEHAVIORAL

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.

Interventions

HELP Vets Intervention

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.

Intervention Type: BEHAVIORAL

Individual Education Program

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mara Z Vitolins, DrPH MPH RDN

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

W.G. "Bill" Hefner VA Medical Center

Salisbury, North Carolina, United States

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R34DK108100

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00033688

Identifier Type: -

Identifier Source: org_study_id