Obesity, Pre-diabetes
Conditions
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.
Interventions
BEHAVIORALHELP 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.
BEHAVIORALIndividual 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
US Department of Veterans Affairs
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment of Study Participants | 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. |
| Retention of Study Participants | 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. |
| Adherence to the Lifestyle Weight Loss Intervention | 6 months | The proportion of intervention sessions attended will be calculated. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants for Whom Fasting Glucose is Available at 6-months Post-randomization | 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. |
| Proportion of Participants for Whom Cholesterol (Lipid Panel) is Available at 6-months Post-randomization | 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. |
| Weight | 6 months | The means and standard deviations at 6 months will be calculated. |
| Cholesterol (Lipid Panel) | 6 months | The means and standard deviations at 6 months will be calculated. |
| Fasting Glucose | 6 months | The means and standard deviations at 6 months will be calculated. |
| Systolic Blood Pressure | 6 months | The means and standard deviations at 6 months will be calculated. |
| Diastolic Blood Pressure | 6 months | The means and standard deviations at 6 months will be calculated. |
Countries
United States
Participant flow
Pre-assignment details
Of 118 enrolled participants, 58 met inclusion criteria. 51 participants were randomized. 1 had to withdraw pre-intervention initiation due to cancer diagnosis. 50 participants were randomized and received the intervention treatment.
Participants by arm
| Arm | Count |
|---|---|
| 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
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. | 26 |
| Enhanced Usual Care Behavioral: Individual Education Program
Standard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter
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. | 25 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Cancer diagnosis prior intervention | 1 | 0 |
| Overall Study | Declined in-person follow-up visit | 4 | 2 |
Baseline characteristics
| Characteristic | Enhanced Usual Care | Total | Lifestyle Weight Loss |
|---|---|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 11.4 | 62.1 years STANDARD_DEVIATION 11.6 | 60.1 years STANDARD_DEVIATION 11.5 |
| Cholesterol (Lipid Panel) | 24 Participants | 43 Participants | 19 Participants |
| Diastolic Blood Pressure | 80.8 mmHg STANDARD_DEVIATION 7.5 | 80.9 mmHg STANDARD_DEVIATION 7.4 | 81.0 mmHg STANDARD_DEVIATION 7.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 50 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fasting Glucose | 24 Participants | 42 Participants | 18 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 22 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 27 Participants | 11 Participants |
| Region of Enrollment United States | 25 participants | 51 participants | 26 participants |
| Sex: Female, Male Female | 2 Participants | 11 Participants | 9 Participants |
| Sex: Female, Male Male | 23 Participants | 40 Participants | 17 Participants |
| Systolic Blood Pressure | 132.8 mmHg STANDARD_DEVIATION 12.4 | 133.2 mmHg STANDARD_DEVIATION 13.3 | 133.5 mmHg STANDARD_DEVIATION 14.4 |
| Weight | 231.9 pounds STANDARD_DEVIATION 30.5 | 227.3 pounds STANDARD_DEVIATION 31.6 | 222.8 pounds STANDARD_DEVIATION 32.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Adherence to the Lifestyle Weight Loss Intervention
The proportion of intervention sessions attended will be calculated.
Time frame: 6 months
Population: Participants in the Enhanced Usual Care Group were not asked to attend intervention sessions.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Proportion of Eligible Participants of Total Screened | Adherence to the Lifestyle Weight Loss Intervention | 14 sessions attended |
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Proportion of Eligible Participants of Total Screened | Recruitment of Study Participants | 58 Participants |
| Proportion of Eligible Participants Who Were Randomized | Recruitment of Study Participants | 51 Participants |
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Proportion of Eligible Participants of Total Screened | Retention of Study Participants | 21 Participants |
| Proportion of Eligible Participants Who Were Randomized | Retention of Study Participants | 23 Participants |
Other Pre-specified
Cholesterol (Lipid Panel)
The means and standard deviations at 6 months will be calculated.
Time frame: 6 months
Population: Data not collected
Other Pre-specified
Diastolic Blood Pressure
The means and standard deviations at 6 months will be calculated.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Proportion of Eligible Participants of Total Screened | Diastolic Blood Pressure | 79.9 mmHg | Standard Deviation 11.6 |
| Proportion of Eligible Participants Who Were Randomized | Diastolic Blood Pressure | 82.3 mmHg | Standard Deviation 8.5 |
Other Pre-specified
Fasting Glucose
The means and standard deviations at 6 months will be calculated.
Time frame: 6 months
Population: Data not collected
Other Pre-specified
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Proportion of Eligible Participants of Total Screened | Proportion of Participants for Whom Cholesterol (Lipid Panel) is Available at 6-months Post-randomization | 17 Participants |
| Proportion of Eligible Participants Who Were Randomized | Proportion of Participants for Whom Cholesterol (Lipid Panel) is Available at 6-months Post-randomization | 19 Participants |
Other Pre-specified
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Proportion of Eligible Participants of Total Screened | Proportion of Participants for Whom Fasting Glucose is Available at 6-months Post-randomization | 22 Participants |
| Proportion of Eligible Participants Who Were Randomized | Proportion of Participants for Whom Fasting Glucose is Available at 6-months Post-randomization | 20 Participants |
Other Pre-specified
Systolic Blood Pressure
The means and standard deviations at 6 months will be calculated.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Proportion of Eligible Participants of Total Screened | Systolic Blood Pressure | 133.4 mmHg | Standard Deviation 14.1 |
| Proportion of Eligible Participants Who Were Randomized | Systolic Blood Pressure | 133.8 mmHg | Standard Deviation 13.5 |
Other Pre-specified
Weight
The means and standard deviations at 6 months will be calculated.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Proportion of Eligible Participants of Total Screened | Weight | 210.4 pounds | Standard Deviation 32.4 |
| Proportion of Eligible Participants Who Were Randomized | Weight | 229.5 pounds | Standard Deviation 34.5 |