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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00521209
First received: August 24, 2007
Last updated: February 12, 2016
Last verified: February 2016
  Purpose

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.


Condition Intervention
Impoverished Population
Behavioral: Self-Care Stimulating Disease Prevention Program (SCSDPP)
Other: Stand procedures, no intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Improving Health Habits: Self-Care Priorities

Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 97
Study Start Date: March 2008
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Clinic 2 - no intervention
Clinic 2 will continue with standard procedures no intervention
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.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521209

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Lillian Gelberg, MD, MSPH Jonsson Comprehensive Cancer Center
  More Information

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00521209     History of Changes
Other Study ID Numbers: CDR0000561559  R21CA112441-01  P30CA016042  UCLA-G-060801501A 
Study First Received: August 24, 2007
Last Updated: February 12, 2016
Health Authority: United States: UCLA Institutional Review Board

Keywords provided by Jonsson Comprehensive Cancer Center:
Impoverished Population

ClinicalTrials.gov processed this record on April 27, 2016