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

September 2, 2020 updated by: Wake Forest University Health Sciences

The Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • W.G. "Bill" Hefner VA Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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

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.
Active Comparator: Enhanced Usual Care

Behavioral: Individual Education Program

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment of Study Participants
Time Frame: 6 months
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.
6 months
Retention of Study Participants
Time Frame: 6 months
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.
6 months
Adherence to the Lifestyle Weight Loss Intervention
Time Frame: 6 months
The proportion of intervention sessions attended will be calculated.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 6 months
The means and standard deviations at 6 months will be calculated.
6 months
Systolic Blood Pressure
Time Frame: 6 months
The means and standard deviations at 6 months will be calculated.
6 months
Diastolic Blood Pressure
Time Frame: 6 months
The means and standard deviations at 6 months will be calculated.
6 months
Proportion of Participants for Whom Fasting Glucose is Available at 6-months Post-randomization
Time Frame: 6 months
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.
6 months
Proportion of Participants for Whom Cholesterol (Lipid Panel) is Available at 6-months Post-randomization
Time Frame: 6 months
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.
6 months
Fasting Glucose
Time Frame: 6 months
The means and standard deviations at 6 months will be calculated.
6 months
Cholesterol (Lipid Panel)
Time Frame: 6 months
The means and standard deviations at 6 months will be calculated.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2017

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

July 15, 2016

First Posted (Estimate)

July 18, 2016

Study Record Updates

Last Update Posted (Actual)

September 24, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00033688
  • R34DK108100 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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