Heart DiseasePhase 2NCT01714271
Promotora-based Latino Family CVD Risk Reduction
A Phase 2 study testing Home environs-based lifestyle counseling and Cancer early detection in people with Heart Disease and Cancer, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This family environment-focused health behavior change intervention is being carried out by extensively trained community health workers (promotores) familiar with the community in East Los Angeles. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Disease, Cancer
- What is being tested?
- Home environs-based lifestyle counseling and Cancer early detection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Oct 2014
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Resides in East Los Angeles
- Home includes family member (spouse or 1st degree relative)who has been diagnosed with type 2 diabetes
Who cannot join
- BMI>40;
- Any condition that prevents engaging in daily physical activity / walking;
- pregnant;
- breast feeding;
- cardiovascular (CVD) event within 12 months;
- cancer requiring chemotherapy;
- other medical condition requiring active lifestyle intervention/dialysis;
- severe CVD or other disease known to significantly limit life expectancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Roybal Comprehensive Health Center
Los Angeles, California, 90022
About this study
Official title: Promotora-based Latino Family CVD Risk Reduction: Remaking the Home Environment
This family environment-focused health behavior change intervention is being carried out by extensively trained community health workers (promotores) familiar with the community in East Los Angeles. The hypothesis being tested is that home environment-focused health behavior change will reduce risk of arterial stiffness, an early-in-life predictor of heart disease. The community health workers will provide most of the health promotion counseling. The promotores will provide up to 16 counseling sessions to a designated adult family member without diabetes. The sessions will focus on improving the home environment in order to reduce television viewing, increase fruit and vegetable intake, decrease intake of refined carbohydrates, prompt more frequent monitoring of body weight and increase daily physical activity. The lifestyle change goals will be tailored to the families' capacity for change and will be consistent with the Dietary Guidelines for Americans, especially the MyPlate.gov messages, the Dietary Approaches to Stop Hypertension (DASH) diet and at least 30 minutes of daily moderate physical activity.
Read the detailed description
This is a randomized controlled trial involving non-diabetic residents of East Los Angeles, most of whom are low-income, mostly immigrant Mexican Americans. The family environment-focused health behavior change intervention is being carried out by extensively trained community health workers (promotores) familiar with the community in East Los Angeles. The comparison condition is a more traditional health education approach to teaching residents about practical early cancer detection strategies designed to reduce risk of death from cancer.
The hypothesis being tested is that home environment-focused health behavior change will reduce risk of arterial stiffness, an early-in-life predictor of heart disease. The community health workers will provide most of the health promotion counseling. The promotores will provide up to 16 counseling sessions to a designated adult family member without diabetes. The sessions will focus on improving the home environment in order to reduce television viewing, increase fruit and vegetable intake, decrease intake of refined carbohydrates, prompt more frequent monitoring of body weight and increase daily physical activity. The lifestyle change goals will be tailored to the families' capacity for change and will be consistent with the Dietary Guidelines for Americans, especially the MyPlate.gov messages, the Dietary Approaches to Stop Hypertension (DASH) diet and at least 30 minutes of daily moderate physical activity.
Secondary outcomes include: aerobic fitness, fruit and vegetable intake as assessed by food frequency questionnaire, endothelial function, body mass index, waist circumference, blood pressure, a metabolic syndrome score, and quality of life. Relative to the cancer early detection condition, the lifestyle change intervention is expected to improve fitness, increase fruit and vegetable intake, improve endothelial function, improve BMI, reduce excess waist circumference, improve blood pressure, and improve quality of life.
If results confirm hypotheses, the results will support investing more public health resources into environmental and policy strategies design to make it easier for populations to adhere to the Dietary Guidelines for Americans and the Physical Activity Guidelines for Americans.
- Conditions
- Heart Disease, Cancer
- Being tested
- Home environs-based lifestyle counseling, Cancer early detection
- Medical subject headings
- Heart Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home environs-based lifestyle counselingBehavioural
Social learning theory-based behavior modification embedded in a social ecological framework is used to shape both the home environment and the lifestyle choices of the study participants to optimize their adherence to the Dietary Guidelines for Americans and the Physical Activity Guidelines for Americans.
Cancer early detectionBehavioural
Conventional health education is used to increase study participant knowledge of practical strategies for detecting and treating common cancers early, before cancers have metastasized. Additional instruction is devoted to the biology and physiology of the cancer process. Although some mention will be made of the importance of maintaining a healthy weight for minimizing lifetime risk of certain cancers, most of the focus will be on episodic cancer screening, e.g., mammograms, PAP smears, colonoscopies, etc. for prevention of death from cancer.
| Study group | Role | What they receive |
|---|---|---|
| Home environs-based lifestyle counseling | Experimental | Home environs-based lifestyle counseling Involves Spanish-speaking community health workers interacting with intervention subjects in home visits and phone calls - 12 contacts overall. The counseling focuses on promoting subject adherence to the Dietary Guidelines for Americans (DGA) and the Physical Activity Guidelines for Americans (PAGA) with special attention devoted to changing the home environment to make it optimally supportive of the lifestyle choices consistent with the DGA and PAGA. Study participants will also be provided 4 group education sessions that will be devoted to improving subject adherence to the DGA and PAGA. Receives: Behavioral: Home environs-based lifestyle counseling |
| Cancer early detection | Experimental | Cancer Early Detection Spanish-speaking health educators will interact with study participants via a home visit and four telephone calls. The focus of the health education will be on practical strategies to detect cancer early to help prevent death from cancer. Cancer sites of interest will be: breast, cervical, skin, colon, prostate and testicular cancers. In addition, study participants will be provided two group education classes that will focus on the basics of the cancer process and why early detection and intervention can be life-saving. Receives: Behavioral: Cancer early detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in arterial stiffness as measured by pulse wave velocity
Pulse wave velocity is a measure of arterial stiffness that is sensitive to changes in health-related lifestyle changes.
Measured: baseline, 6, 12, 24 months follow-up
Change in arterial stiffness as measured by the Augmentation index
Augmentation index is another measure of arterial stiffness, also sensitive to changes in health-related lifestyle behaviors.
Measured: baseline, 6, 12 and 24 months follow-up
Secondary outcomes (16)
Change in fasting glucose
Fasting blood glucose
Measured: baseline, 6, 12, 24 months
Changes in glycosylated hemoglobin A1c (HbA1c)
Glycosylated hemoglobin A1c. Measure of glucose control over several months.
Measured: baseline, 6, 12, 24 months follow-up
Changes in answers to MyPlate evaluation questions
Self-report questions about adherence to MyPlate.gov recommendations. These include questions about daily fruit intake, vegetable intake, replacement of sugary beverages with water, effort to make at least 1/2 of grain intake whole grain, effort to seek out lower sodium options, and daily intake of non-fat or low-fat milk.
Measured: baseline, 6, 12, 24 months follow-up
Changes in food frequency measure of fruit and vegetable intake
Block Food Frequency assessment conducted in Spanish by interview. Information will include estimate of total fruit and vegetable intake over the last 6 months.
Measured: Baseline, 6, 12, 24 months follow-up
Changes in waist circumference
Measure of waist circumference, a common predictor of cardiovascular risk
Measured: baseline, 6, 12 and 24 months
Change in aerobic capacity
Bruce protocol treadmill test. Estimate the VO2max (maximum aerobic capacity) using Foster's equation.
Measured: Baseline, 6, 12, 24 months
Change in metabolic syndrome score
Metabolic syndrome marker levels. The ATP III criteria for metabolic syndrome markers include:
- sex-specific excess waist circumference (men > 102 cm, women >88 cm),
- fasting plasma triglycerides >= 120 mg/dl,
- fasting plasma HDL(men)<40 or (women)<50 mg/dl,
- blood pressure >=135/85,
- fasting glucose >=110 mg/dl). Each subject's metabolic syndrome marker level can range between zero and five, with zero representing no metabolic syndrome risk and five representing maximum risk. The a priori expectation is that each marker will be treated as equally important but this study will provide the opportunity to examine this assumption critically.
Measured: Baseline, 6, 12, 24 months
Change in plasma lipids
Plasma lipids to be measured include LDL-cholesterol, HDL-cholesterol and triglycerides. Blood samples will be obtained by venipuncture.
Measured: Baseline, 6, 12, 24 months
Change in blood pressure
Blood pressure will be assessed in study participants sitting quietly by trained personnel using regularly calibrated sphygmomanometry.
Measured: Baseline, 6, 12, 24 months
Change in physical activity assessment
International Physical Activity Questionnaire - short form (IPAQ-short). Questions ask about the number of days in the last 7 days that the participant exercised vigorously or moderately vigorously. Follow-up questions query the participant about the time (minutes \& hours) spent per day in doing vigorous or moderately vigorous physical activity on those days when they exercised.
Measured: Baseline, 6, 12, 24 months
Change in body mass index (BMI)
Body mass index (BMI) obtained by taking the ratio of measured weight (kg) to measured height (m). Weight is obtained using a regularly calibrated balance beam scale. Height is obtained using a stationary stadiometer.
Measured: Baseline, 6, 12, 24 months
Change in quality of life
The SF-12 is a well-accepted short form of the well-known SF-36 quality of life instrument.
Measured: Baseline, 6, 12, 24
Change in weight loss strategies
Questionnaire includes 11 items that query the participant about weight control strategies used in the last year, including: exercise, restricting calories, fasting, diet pills, vomiting / laxative use, joining a gym, joining a commercial weight loss program such as WeightWatchers, meal replacement products, herbal medicines, diet bars, restriction on TV watching.
Measured: Baseline, 6, 12, 24
Change in endothelial function
Flow-mediated dilation is the most widely used non-invasive test for assessing endothelial function, that is, the functional status of the inner lining of the major blood vessels. This technique measures endothelial function by inducing reactive hyperemia (blood volume expansion) via temporary arterial occlusion (blocking blood flow with inflated blood pressure cuff) and measuring the resultant relative increase in blood vessel diameter via ultrasound.
Measured: Baseline, 6, 12, 24 months
Change in self-efficacy to adhere to DASH-style dietary pattern
List of 10 self-efficacy items that assess the study participant's confidence that she/he can adhere to various features of the Dietary Approaches to Stop Hypertension (DASH) diet.
Measured: Baseline, 6, 12, 24 months
Change in mental health status
Mental health index-5 (MHI-5) consists of 5 questionnaire items designed to assess emotional well-being.
Measured: Baseline, 6, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startOct 2010
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William J McCarthy, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714271
- Sponsor's protocol ID
- 1P50HL105188-6094
- Other IDs
- 1P50HL105188
- Status last verified
- Sep 2023
- First submitted
- 20 Oct 2012
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotora-based Latino Family CVD Risk Reduction: Remaking the Home Environment
- ClinicalTrials.gov ID
- NCT01714271
- Acronym / sponsor ID
- 1P50HL105188-6094
- Conditions
- Heart Disease, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of Southern California, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 25 Oct 2012 (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.
This family environment-focused health behavior change intervention is being carried out by extensively trained community health workers (promotores) familiar with the community in East Los Angeles. The hypothesis being tested is that home environment-focused health behavior change will reduce risk of arterial stiffness, an early-in-life predictor of heart disease. The community health workers will provide most of the health promotion counseling. The promotores will provide up to 16 counseling sessions to a designated adult family member without diabetes. The sessions will focus on improving the home environment in order to reduce television viewing, increase fruit and vegetable intake, decrease intake of refined carbohydrates, prompt more frequent monitoring of body weight and increase daily physical activity. The lifestyle change goals will be tailored to the families' capacity for change and will be consistent with the Dietary Guidelines for Americans, especially the MyPlate.gov messages, the Dietary Approaches to Stop Hypertension (DASH) diet and at least 30 minutes of daily moderate physical activity.
Detailed description
This is a randomized controlled trial involving non-diabetic residents of East Los Angeles, most of whom are low-income, mostly immigrant Mexican Americans. The family environment-focused health behavior change intervention is being carried out by extensively trained community health workers (promotores) familiar with the community in East Los Angeles. The comparison condition is a more traditional health education approach to teaching residents about practical early cancer detection strategies designed to reduce risk of death from cancer.
The hypothesis being tested is that home environment-focused health behavior change will reduce risk of arterial stiffness, an early-in-life predictor of heart disease. The community health workers will provide most of the health promotion counseling. The promotores will provide up to 16 counseling sessions to a designated adult family member without diabetes. The sessions will focus on improving the home environment in order to reduce television viewing, increase fruit and vegetable intake, decrease intake of refined carbohydrates, prompt more frequent monitoring of body weight and increase daily physical activity. The lifestyle change goals will be tailored to the families' capacity for change and will be consistent with the Dietary Guidelines for Americans, especially the MyPlate.gov messages, the Dietary Approaches to Stop Hypertension (DASH) diet and at least 30 minutes of daily moderate physical activity.
Secondary outcomes include: aerobic fitness, fruit and vegetable intake as assessed by food frequency questionnaire, endothelial function, body mass index, waist circumference, blood pressure, a metabolic syndrome score, and quality of life. Relative to the cancer early detection condition, the lifestyle change intervention is expected to improve fitness, increase fruit and vegetable intake, improve endothelial function, improve BMI, reduce excess waist circumference, improve blood pressure, and improve quality of life.
If results confirm hypotheses, the results will support investing more public health resources into environmental and policy strategies design to make it easier for populations to adhere to the Dietary Guidelines for Americans and the Physical Activity Guidelines for Americans.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home environs-based lifestyle counseling | Experimental | Behavioral: Home environs-based lifestyle counselingHome environs-based lifestyle counseling Involves Spanish-speaking community health workers interacting with intervention subjects in home visits and phone calls - 12 contacts overall. The counseling focuses on promoting subject adherence to the Dietary Guidelines for Americans (DGA) and the Physical Activity Guidelines for Americans (PAGA) with special attention devoted to changing the home environment to make it optimally supportive of the lifestyle choices consistent with the DGA and PAGA. Study participants will also be provided 4 group education sessions that will be devoted to improving subject adherence to the DGA and PAGA. |
| Cancer early detection | Experimental | Behavioral: Cancer early detectionCancer Early Detection Spanish-speaking health educators will interact with study participants via a home visit and four telephone calls. The focus of the health education will be on practical strategies to detect cancer early to help prevent death from cancer. Cancer sites of interest will be: breast, cervical, skin, colon, prostate and testicular cancers. In addition, study participants will be provided two group education classes that will focus on the basics of the cancer process and why early detection and intervention can be life-saving. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Resides in East Los Angeles
- Home includes family member (spouse or 1st degree relative)who has been diagnosed with type 2 diabetes
Key exclusion criteria (8 listed)
- BMI>40;
- Any condition that prevents engaging in daily physical activity / walking;
- pregnant;
- breast feeding;
- cardiovascular (CVD) event within 12 months;
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 |
|---|---|---|
| Home environs-based lifestyle counselingSocial learning theory-based behavior modification embedded in a social ecological framework is used to shape both the home environment and the lifestyle choices of the study participants to optimize their adherence to the Dietary Guidelines for Americans and the Physical Activity Guidelines for Americans. | Behavioural | Home environs-based lifestyle counseling |
| Cancer early detectionConventional health education is used to increase study participant knowledge of practical strategies for detecting and treating common cancers early, before cancers have metastasized. Additional instruction is devoted to the biology and physiology of the cancer process. Although some mention will be made of the importance of maintaining a healthy weight for minimizing lifetime risk of certain cancers, most of the focus will be on episodic cancer screening, e.g., mammograms, PAP smears, colonoscopies, etc. for prevention of death from cancer. | Behavioural | Cancer early detection |
Primary outcome
Change in arterial stiffness as measured by pulse wave velocity
Time frame: baseline, 6, 12, 24 months follow-up
Pulse wave velocity is a measure of arterial stiffness that is sensitive to changes in health-related lifestyle changes.
Change in arterial stiffness as measured by the Augmentation index
Time frame: baseline, 6, 12 and 24 months follow-up
Augmentation index is another measure of arterial stiffness, also sensitive to changes in health-related lifestyle behaviors.
16 secondary outcomes
Change in fasting glucose
Time frame: baseline, 6, 12, 24 months
Changes in glycosylated hemoglobin A1c (HbA1c)
Time frame: baseline, 6, 12, 24 months follow-up
Changes in answers to MyPlate evaluation questions
Time frame: baseline, 6, 12, 24 months follow-up
Changes in food frequency measure of fruit and vegetable intake
Time frame: Baseline, 6, 12, 24 months follow-up
Changes in waist circumference
Time frame: baseline, 6, 12 and 24 months
Change in aerobic capacity
Time frame: Baseline, 6, 12, 24 months
Change in metabolic syndrome score
Time frame: Baseline, 6, 12, 24 months
Change in plasma lipids
Time frame: Baseline, 6, 12, 24 months
Change in blood pressure
Time frame: Baseline, 6, 12, 24 months
Change in physical activity assessment
Time frame: Baseline, 6, 12, 24 months
Change in body mass index (BMI)
Time frame: Baseline, 6, 12, 24 months
Change in quality of life
Time frame: Baseline, 6, 12, 24
Change in weight loss strategies
Time frame: Baseline, 6, 12, 24
Change in endothelial function
Time frame: Baseline, 6, 12, 24 months
Change in self-efficacy to adhere to DASH-style dietary pattern
Time frame: Baseline, 6, 12, 24 months
Change in mental health status
Time frame: Baseline, 6, 12, 24
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 2 Oct 2023.
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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 J McCarthy, Ph.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Home environs-based lifestyle counseling and Cancer early detection in people with Heart Disease and Cancer, run by University of California, Los Angeles 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?
The sponsor lists 2 inclusion and 8 exclusion criteria. 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 2 Oct 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in arterial stiffness as measured by pulse wave velocity (time frame: baseline, 6, 12, 24 months follow-up). The study lists 2 primary outcomes in all. 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 2 Oct 2023.