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Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study (HELP Vets)

Primary Purpose

Pre-diabetes, Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

HELP Vets Intervention

Individual Education Program

About this trial

This is an interventional prevention trial for Pre-diabetes

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

W.G. "Bill" Hefner VA Medical Center
Wake Forest School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lifestyle Weight Loss

Enhanced Usual Care

Arm Description

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

Behavioral: Individual Education Program Standard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter

Outcomes

Primary Outcome Measures

Recruitment of Study Participants

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.

Retention of Study Participants

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.

Adherence to the Lifestyle Weight Loss Intervention

The proportion of intervention sessions attended will be calculated.

Secondary Outcome Measures

Full Information

NCT ID

NCT02835495

First Posted

July 13, 2016

Last Updated

September 2, 2020

Sponsor

Wake Forest University Health Sciences

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), US Department of Veterans Affairs

1. Study Identification

Unique Protocol Identification Number

NCT02835495

Brief Title

Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study

Acronym

HELP Vets

Official Title

The Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

November 15, 2017 (Actual)

Primary Completion Date

August 30, 2019 (Actual)

Study Completion Date

August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), US Department of Veterans Affairs

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pre-diabetes, Obesity

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

118 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lifestyle Weight Loss

Arm Type

Experimental

Arm Description

Arm Title

Enhanced Usual Care

Arm Type

Active Comparator

Arm Description

Behavioral: Individual Education Program Standard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter

Intervention Type

Behavioral

Intervention Name(s)

HELP Vets Intervention

Intervention Description

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

Intervention Name(s)

Individual Education Program

Intervention Description

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.

Primary Outcome Measure Information:

Title

Recruitment of Study Participants

Description

Time Frame

6 months

Title

Retention of Study Participants

Description

Time Frame

6 months

Title

Adherence to the Lifestyle Weight Loss Intervention

Description

The proportion of intervention sessions attended will be calculated.

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

Weight

Description

The means and standard deviations at 6 months will be calculated.

Time Frame

6 months

Title

Systolic Blood Pressure

Description

The means and standard deviations at 6 months will be calculated.

Time Frame

6 months

Title

Diastolic Blood Pressure

Description

The means and standard deviations at 6 months will be calculated.

Time Frame

6 months

Title

Proportion of Participants for Whom Fasting Glucose is Available at 6-months Post-randomization

Description

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.

Time Frame

6 months

Title

Proportion of Participants for Whom Cholesterol (Lipid Panel) is Available at 6-months Post-randomization

Description

Time Frame

6 months

Title

Fasting Glucose

Description

The means and standard deviations at 6 months will be calculated.

Time Frame

6 months

Title

Cholesterol (Lipid Panel)

Description

The means and standard deviations at 6 months will be calculated.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mara Z Vitolins, DrPH MPH RDN

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

W.G. "Bill" Hefner VA Medical Center

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

Wake Forest School of Medicine

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study

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