Patient-Directed Lifestyle Change and Health Promotion Program or Usual Care in Low-Income, Uninsured Participants in Los Angeles County, California
Condition: Impoverished Population
Study type: Interventional

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.
    

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.
    

Intervention name(s): Self-Care Stimulating Disease Prevention Program (SCSDPP); Stand procedures, no intervention
Intervention type(s): Behavioral; Other
Intervention description(s): 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
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Impoverished Population