Impoverished PopulationNCT00521209
Patient-Directed Lifestyle Change and Health Promotion Program or Usual Care in Low-Income, Uninsured Participants in Los Angeles County, California
A study testing Self-Care Stimulating Disease Prevention Program (SCSDPP) in people with Impoverished Population, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Impoverished Population
- What is being tested?
- Self-Care Stimulating Disease Prevention Program (SCSDPP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to 8 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
About this study
Official title: Improving Health Habits: Self-Care Priorities
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.
Read the 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.
- Conditions
- Impoverished Population
- Being tested
- Self-Care Stimulating Disease Prevention Program (SCSDPP), Stand procedures, no intervention
- Keywords
- Impoverished Population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Care Stimulating Disease Prevention Program (SCSDPP)Behavioural
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
Stand procedures, no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Clinic 1 - intervention | Experimental | Clinic 1 will feature the Self-Care Stimulating Disease Prevention Program (SCSDPP) intervention Receives: Behavioral: Self-Care Stimulating Disease Prevention Program (SCSDPP) |
| Clinic 2 - no intervention | Other | Clinic 2 will continue with standard procedures no intervention Receives: Other: Stand procedures, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects that have behavior changes as a result of using the Self-Care Stimulating Disease Prevention Program
Measured: Through study completion, expected to be 10 years
Secondary outcomes (1)
Ease of integration of the SCSDPP into the community health clinic setting through the number of subjects that implement life style changes
Measured: Through study completion, expected to be 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study startMar 2008
- Primary completion8 Aug 2022
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impoverished PopulationStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- William McCarthy, PhD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521209
- Sponsor's protocol ID
- 11-002325
- Other IDs
- R21CA112441-01, UCLA-G-060801501A, CDR0000561559
- Status last verified
- May 2023
- First submitted
- 24 Aug 2007
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health Habits: Self-Care Priorities
- ClinicalTrials.gov ID
- NCT00521209
- Acronym / sponsor ID
- 11-002325
- Conditions
- Impoverished Population
- Keywords
- Impoverished Population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2008 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 27 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinic 1 - intervention | Experimental | Behavioral: Self-Care Stimulating Disease Prevention Program (SCSDPP)Clinic 1 will feature the Self-Care Stimulating Disease Prevention Program (SCSDPP) intervention |
| Clinic 2 - no intervention | Other | Other: Stand procedures, no interventionClinic 2 will continue with standard procedures no intervention |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Clinic 1 - intervention |
| Stand procedures, no intervention | Other | Clinic 2 - no intervention |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Impoverished Population
Active, not recruiting
An mHealth-based Healthcare Professional-Lay Health Worker Partnership Program (mHLPP)
Impoverished Population, Older Adults (60 - 85 Years Old)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William McCarthy, PhD principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Care Stimulating Disease Prevention Program (SCSDPP) in people with Impoverished Population, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.