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

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.

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