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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA112441-01 | U.S. NIH Grant/Contract | View source | |
| UCLA-G-060801501A | |||
| CDR0000561559 | Other Identifier | UCLA |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Clinic-based health programs may be effective in improving the diets and physical activity levels of low-income, uninsured participants in Los Angeles County, California.
PURPOSE: This randomized clinical trial is studying a patient-directed lifestyle change and health promotion program to see how well it works compared with usual care in low-income, uninsured participants in Los Angeles County, California.
OBJECTIVES:
OUTLINE: The two participating clinics are randomly assigned to provide care as outlined below to participants who routinely visit that clinic.
In both arms, participants also undergo a 30-minute interview about diet and physical activity and take a step test to measure heart rate and oxygen level during the follow-up visits. All participants undergo an exit interview at the end of the study about their perceptions of the program and what can be improved in the study. Participants' medical record information is examined for the period of 12 months prior to enrollment in the study, during the 12-month study period, and for 12 months after the exit interview date.
PROJECTED ACCRUAL: A total of 140 participants (40 for arm I and 100 for arm II) will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinic 1 - intervention | Experimental | Clinic 1 will feature the Self-Care Stimulating Disease Prevention Program (SCSDPP) intervention |
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| Clinic 2 - no intervention | Other | Clinic 2 will continue with standard procedures no intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-Care Stimulating Disease Prevention Program (SCSDPP) | Behavioral | The SCSDPP development is guided by the following premises: a) patient-directed lifestyle change or "self-prescription" of behavior change is potentially a more empowering, sustainable, and proactive approach to addressing personal health habits than the more conventional physician-directed approach; b) patient-directed lifestyle change or "self-prescription" of behavior change is potentially an important predictor of self-efficacy and long-term adherence to healthy habits; c) behavior change in isolation is less sustainable than change that is reinforced by other distinct but related changes (e.g., the potential synergy of improving diet and physical activity concurrently to prevent chronic disease); d) a multi-level change directed at the service delivery system and physician support, however small, has the added benefit of potentially reducing provider and staff burden while maximizing available clinic and community resources; and f) brief physician counseling |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects that have behavior changes as a result of using the Self-Care Stimulating Disease Prevention Program | Through study completion, expected to be 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of integration of the SCSDPP into the community health clinic setting through the number of subjects that implement life style changes | Through study completion, expected to be 10 years |
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DISEASE CHARACTERISTICS:
Receiving care at one of two study sites within the Venice Family Clinic network of clinics: Simms-Mann Clinic or Rose Avenue Clinic
Low income level and uninsured, and therefore at increased risk for nutrition- and lifestyle-related health conditions, including overweight, obesity, and cancer
Shows interest in changing diet and physical activity behavior as indicated by response to Patient Health Behavior Priority Assessment (PHBPA)
No history of cancer, except non-melanoma skin cancer or in situ cancers
Prticipated in the focus group discussion or cognitive interview for the pre-intervention portion of the study (IRB #G06-08-014-01)
PATIENT CHARACTERISTICS:
English- or Spanish-speaking
Accessible by telephone where they can be contacted over time during the study to conduct follow-up health education phone calls
Willing to cooperate with data collection (e.g., lab draws, completing interviews, etc.)
Not pregnant
No medical condition precluding free choice of foods (e.g., colitis, irritable bowel syndrome, or diabetes)
No medical condition precluding participation in common forms of aerobic or resistance exercise, including any of the following:
No cognitive impairment
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| William McCarthy, PhD | Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | 90095-1781 | United States |
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| Stand procedures, no intervention | Other |
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