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

Overview

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.

Full Title of Study: “Improving Health Habits: Self-Care Priorities”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2020

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.

Interventions

  • 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: Stand procedures, no intervention

Arms, Groups and Cohorts

  • Experimental: Clinic 1 – intervention
    • Clinic 1 will feature the Self-Care Stimulating Disease Prevention Program (SCSDPP) intervention
  • Other: Clinic 2 – no intervention
    • Clinic 2 will continue with standard procedures no intervention

Clinical Trial Outcome Measures

Primary Measures

  • Number of subjects that have behavior changes as a result of using the Self-Care Stimulating Disease Prevention Program
    • Time Frame: Through study completion, expected to be 10 years

Secondary Measures

  • Ease of integration of the SCSDPP into the community health clinic setting through the number of subjects that implement life style changes
    • Time Frame: Through study completion, expected to be 10 years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 120 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Jonsson Comprehensive Cancer Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lillian Gelberg, MD, MSPH, Study Chair, Jonsson Comprehensive Cancer Center

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