Patient-Directed Lifestyle Change and Health Promotion Program or Usual Care in Low-Income, Uninsured Participants in Los Angeles County, California

NCT00521209 | Completed

• 4 other identifiers: 11-002325R21CA112441-01UCLA-G-060801501ACDR0000561559
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Impoverished Population

Keywords

Impoverished Population

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

Clinic 1 - intervention

EXPERIMENTAL

Clinic 1 will feature the Self-Care Stimulating Disease Prevention Program (SCSDPP) intervention

Behavioral: Self-Care Stimulating Disease Prevention Program (SCSDPP)

Clinic 2 - no intervention

OTHER

Clinic 2 will continue with standard procedures no intervention

Other: Stand procedures, no intervention

Interventions

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

Clinic 1 - intervention

Stand procedures, no intervention OTHER

Clinic 2 - no intervention

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 * Must remain in the Los Angeles area during the 12-month study period * 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: * Uncontrolled angina * Severe asthma or hypertension * Severe physical impairment that requires a wheelchair, cane, or special bed * Congestive heart failure * Nephropathy from any cause * Chronic pulmonary disease * No cognitive impairment PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Study Officials

• William McCarthy, PhD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2007
• First Posted: August 27, 2007
• Study Start: March 1, 2008
• Primary Completion: August 8, 2022
• Study Completion: August 8, 2022
• Last Updated: August 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)