Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study
HELP Vets
The Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study
2 other identifiers
interventional
118
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2017
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2016
CompletedFirst Posted
Study publicly available on registry
July 18, 2016
CompletedStudy Start
First participant enrolled
November 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2019
CompletedResults Posted
Study results publicly available
September 24, 2020
CompletedSeptember 24, 2020
September 1, 2020
1.8 years
July 13, 2016
September 2, 2020
September 2, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
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.
6 months
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.
6 months
Adherence to the Lifestyle Weight Loss Intervention
The proportion of intervention sessions attended will be calculated.
6 months
Other Outcomes (7)
Weight
6 months
Systolic Blood Pressure
6 months
Diastolic Blood Pressure
6 months
- +4 more other outcomes
Study Arms (2)
Lifestyle Weight Loss
EXPERIMENTALBehavioral: 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
Enhanced Usual Care
ACTIVE COMPARATORBehavioral: Individual Education Program Standard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
W.G. "Bill" Hefner VA Medical Center
Salisbury, North Carolina, 28144, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
As this was a pilot feasibility study, only a small number of participants were included and analyzed.
Results Point of Contact
- Title
- Mara Z. Vitolins, DrPH, MPH, RDN
- Organization
- Wake Forest School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Mara Z Vitolins, DrPH MPH RDN
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2016
First Posted
July 18, 2016
Study Start
November 15, 2017
Primary Completion
August 30, 2019
Study Completion
August 30, 2019
Last Updated
September 24, 2020
Results First Posted
September 24, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share