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

Jonsson Comprehensive Cancer Center

Status: Completed

Conditions: Impoverished Population

Treatments: Other: Stand procedures, no intervention; Behavioral: Self-Care Stimulating Disease Prevention Program (SCSDPP)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00521209

11-002325

UCLA-G-060801501A

R21CA112441-01 (U.S. NIH Grant/Contract)

CDR0000561559 (Other Identifier)

Details and patient eligibility

About

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 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.

Enrollment: 97 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

Clinic 1 - intervention

Experimental group

Description:

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

Treatment:

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

Clinic 2 - no intervention

Other group

Description:

Clinic 2 will continue with standard procedures no intervention

Treatment:

Other: Stand procedures, no intervention