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

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ClinicalTrials.gov Identifier: NCT02835495
Recruitment Status : Recruiting
First Posted : July 18, 2016
Last Update Posted : June 29, 2018
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
VA Office of Research and Development
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Pre-diabetes Obesity Behavioral: HELP Vets Intervention Behavioral: Individual Education Program Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

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

Behavioral: 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.

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

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.




Primary Outcome Measures :
  1. 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 estimated. The rate of referrals to the program by providers in the local community-based outpatient clinic will also be monitored.

  2. 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.

  3. Adherence to the Lifestyle Weight Loss Intervention [ Time Frame: 6 months ]
    The proportion of intervention sessions attended will be estimated.


Secondary Outcome Measures :
  1. Weight [ Time Frame: 6 months ]
    The means and standard deviations at baseline and 6 months and the correlation over time will be estimated.

  2. Waist Circumference [ Time Frame: 6 months ]
    The means and standard deviations at baseline and 6 months and the correlation over time will be estimated.

  3. Blood Pressure [ Time Frame: 6 months ]
    The means and standard deviations at baseline and 6 months and the correlation over time will be estimated.

  4. Fasting Glucose [ Time Frame: 6 months ]
    The means and standard deviations at baseline and 6 months and the correlation over time will be estimated.

  5. Cholesterol [ Time Frame: 6 months ]
    The means and standard deviations at baseline and 6 months and the correlation over time will be estimated.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 (HbA1c) taken in the three months.
  • The appropriate ranges for each test are
  • 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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835495


Contacts
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Contact: Caroline S Blackwell, BS, CCRP (336) 713-4061 cblackwe@wakehealth.edu
Contact: Mariela N Arias, BS (336) 716-9470 mnarias@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest School of Medicine Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Mariela Arias    336-716-9470    mnarias@wakehealth.edu   
Principal Investigator: Mara Z Vitolins, DrPH MPH RDN         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
VA Office of Research and Development
Investigators
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Principal Investigator: Mara Z Vitolins, DrPH MPH RDN Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02835495     History of Changes
Other Study ID Numbers: IRB00033688
R34DK108100 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia