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| ID | Type | Description | Link |
|---|---|---|---|
| R34DK108100 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| US Department of Veterans Affairs | FED |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Weight Loss | Experimental | 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 |
|
| Enhanced Usual Care | Active Comparator | Behavioral: Individual Education Program Standard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HELP Vets Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Weight | The means and standard deviations at 6 months will be calculated. | 6 months |
| Systolic Blood Pressure | The means and standard deviations at 6 months will be calculated. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mara Z Vitolins, DrPH MPH RDN | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| W.G. "Bill" Hefner VA Medical Center | Salisbury | North Carolina | 28144 | United States | ||
| Wake Forest School of Medicine |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
26 participants were randomized to the lifestyle weight loss intervention; however, one had to withdraw soon after randomization and before intervention initiation due to a cancer diagnosis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
6 months
Adverse events were reported at the 6-month follow-up visit using a standardized questionnaire.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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As this was a pilot feasibility study, only a small number of participants were included and analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mara Z. Vitolins, DrPH, MPH, RDN | Wake Forest School of Medicine | (336) 716-2886 | mvitolinn@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 8, 2017 | May 8, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2018 | Aug 26, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Individual Education Program | Behavioral | 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. |
|
| 6 months |
| Diastolic Blood Pressure | 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 | 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 | 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 | The means and standard deviations at 6 months will be calculated. | 6 months |
| Cholesterol (Lipid Panel) | The means and standard deviations at 6 months will be calculated. | 6 months |
| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | pounds |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Fasting Glucose | In order to assess the feasibility of collecting this data from the electronic medical record, the proportion of participants for whom this data is available at randomization (+/- 90 days) will be reported. | Count of Participants | Participants |
|
| Cholesterol (Lipid Panel) | 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 randomization (+/- 90 days) will be reported. | Count of Participants | Participants |
|
This reports the total number of participants who were randomized of those eligible for participation.
|
|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Primary | Adherence to the Lifestyle Weight Loss Intervention | The proportion of intervention sessions attended will be calculated. | Participants in the Enhanced Usual Care Group were not asked to attend intervention sessions. | Posted | Mean | Inter-Quartile Range | sessions attended | 6 months |
|
|
|
| Other Pre-specified | Weight | The means and standard deviations at 6 months will be calculated. | Posted | Mean | Standard Deviation | pounds | 6 months |
|
|
|
| Other Pre-specified | Systolic Blood Pressure | The means and standard deviations at 6 months will be calculated. | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
|
|
| Other Pre-specified | Diastolic Blood Pressure | The means and standard deviations at 6 months will be calculated. | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Other Pre-specified | Fasting Glucose | The means and standard deviations at 6 months will be calculated. | Data not collected | Posted | 6 months |
|
|
| Other Pre-specified | Cholesterol (Lipid Panel) | The means and standard deviations at 6 months will be calculated. | Data not collected | Posted | 6 months |
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |