Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study

Obesity Clinical Trial

— HELP Vets  

Official title:

The Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835495
• Other study ID #: IRB00033688
• Secondary ID: R34DK108100
• Status: Completed
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: September 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Obesity
• Pre-diabetes
• Prediabetic State

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	W.G. "Bill" Hefner VA Medical Center	Salisbury	North Carolina
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight	The means and standard deviations at 6 months will be calculated.	6 months
Other	Systolic Blood Pressure	The means and standard deviations at 6 months will be calculated.	6 months
Other	Diastolic Blood Pressure	The means and standard deviations at 6 months will be calculated.	6 months
Other	Proportion of Participants for Whom Fasting Glucose is Available at 6-months Post-randomization	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
Other	Proportion of Participants for Whom Cholesterol (Lipid Panel) is Available at 6-months Post-randomization	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
Other	Fasting Glucose	The means and standard deviations at 6 months will be calculated.	6 months
Other	Cholesterol (Lipid Panel)	The means and standard deviations at 6 months will be calculated.	6 months
Primary	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
Primary	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
Primary	Adherence to the Lifestyle Weight Loss Intervention	The proportion of intervention sessions attended will be calculated.	6 months