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

Improving Health Habits: Self-Care Priorities

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.

Study Overview

• Status: Completed
• Conditions: Impoverished Population
• Intervention / Treatment: Behavioral: Self-Care Stimulating Disease Prevention Program (SCSDPP); Other: Stand procedures, no intervention

Detailed Description

OBJECTIVES:

• To evaluate the feasibility and impact of a clinic-based intervention protocol in Los Angeles county, California, for improving the dietary choices and physical activity levels of low-income clinic populations in Los Angeles County, California.

OUTLINE: The two participating clinics are randomly assigned to provide care as outlined below to participants who routinely visit that clinic.

• Arm I (clinic 1, intervention program): Physicians provide health advice to the participants for 1-2 minutes using a motivational interviewing technique during a regularly scheduled appointment. Health messages to motivate changes in diet and physical activity levels are tailored to the participant based on information from the Patient Health Behavior Priority Assessment (PHBPA). Physicians also create a mutually agreed upon self-directed lifestyle change plan (the Health Priority Plan) for the participant using information from the PHBPA. Participants undergo a 10-minute interview to indicate whether the doctor discussed the plan and their satisfaction with the visit. After the first clinic encounter, participants are contacted by a health educator via telephone 4 times over a 2-month period. The telephone sessions are designed to identify obstacles and challenges in adhering to the Health Priority Plan and help participants to persevere with the plan. Participants are followed at baseline, 2 months, and 6 or 12 months. Participants have blood pressure and weight measured and blood collected to determine levels of nutrients and fat and sugar content during these follow-up visits.
• Arm II (clinic 2, control program): Physicians provide usual care during a regularly scheduled appointment. Participants are followed at baseline, 2 months, and 12 months. Participants have blood pressure and weight measured and a subset of participants also have blood collected to determine levels of nutrients and fat and sugar content during these follow-up visits.

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.

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095-1781
      • Jonsson Comprehensive Cancer Center at UCLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clinic 1 - intervention; Clinic 1 will feature the Self-Care Stimulating Disease Prevention Program (SCSDPP) intervention	Behavioral: Self-Care Stimulating Disease Prevention Program (SCSDPP); 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
Other: Clinic 2 - no intervention; Clinic 2 will continue with standard procedures no intervention	Other: Stand procedures, no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: William McCarthy, PhD, Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2008
• Primary Completion (Actual): August 8, 2022
• Study Completion (Actual): August 8, 2022

Study Registration Dates

• First Submitted: August 24, 2007
• First Submitted That Met QC Criteria: August 24, 2007
• First Posted (Estimated): August 27, 2007

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Impoverished Population
• Other Study ID Numbers: 11-002325; R21CA112441-01 (U.S. NIH Grant/Contract); UCLA-G-060801501A; CDR0000561559 (Other Identifier: UCLA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No