- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01714271
Promotora-based Latino Family CVD Risk Reduction
Promotora-based Latino Family CVD Risk Reduction: Remaking the Home Environment
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Valerie Ruelas, LCSW
- Phone Number: 323-361-8416
- Email: VRuelas@chla.usc.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90022
- Roybal Comprehensive Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Resides in East Los Angeles
- Home includes family member (spouse or 1st degree relative)who has been diagnosed with type 2 diabetes
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Home environs-based lifestyle counseling
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.
|
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.
|
Experimental: Cancer early detection
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline, 6, 12, 24 months follow-up
|
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.
|
baseline, 6, 12 and 24 months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fasting glucose
Time Frame: baseline, 6, 12, 24 months
|
Fasting blood glucose
|
baseline, 6, 12, 24 months
|
Changes in glycosylated hemoglobin A1c (HbA1c)
Time Frame: baseline, 6, 12, 24 months follow-up
|
Glycosylated hemoglobin A1c.
Measure of glucose control over several months.
|
baseline, 6, 12, 24 months follow-up
|
Changes in answers to MyPlate evaluation questions
Time Frame: baseline, 6, 12, 24 months follow-up
|
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.
|
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
|
Block Food Frequency assessment conducted in Spanish by interview.
Information will include estimate of total fruit and vegetable intake over the last 6 months.
|
Baseline, 6, 12, 24 months follow-up
|
Changes in waist circumference
Time Frame: baseline, 6, 12 and 24 months
|
Measure of waist circumference, a common predictor of cardiovascular risk
|
baseline, 6, 12 and 24 months
|
Change in aerobic capacity
Time Frame: Baseline, 6, 12, 24 months
|
Bruce protocol treadmill test.
Estimate the VO2max (maximum aerobic capacity) using Foster's equation.
|
Baseline, 6, 12, 24 months
|
Change in metabolic syndrome score
Time Frame: Baseline, 6, 12, 24 months
|
Metabolic syndrome marker levels. The ATP III criteria for metabolic syndrome markers include:
|
Baseline, 6, 12, 24 months
|
Change in plasma lipids
Time Frame: Baseline, 6, 12, 24 months
|
Plasma lipids to be measured include LDL-cholesterol, HDL-cholesterol and triglycerides.
Blood samples will be obtained by venipuncture.
|
Baseline, 6, 12, 24 months
|
Change in blood pressure
Time Frame: Baseline, 6, 12, 24 months
|
Blood pressure will be assessed in study participants sitting quietly by trained personnel using regularly calibrated sphygmomanometry.
|
Baseline, 6, 12, 24 months
|
Change in physical activity assessment
Time Frame: Baseline, 6, 12, 24 months
|
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.
|
Baseline, 6, 12, 24 months
|
Change in body mass index (BMI)
Time Frame: Baseline, 6, 12, 24 months
|
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.
|
Baseline, 6, 12, 24 months
|
Change in quality of life
Time Frame: Baseline, 6, 12, 24
|
The SF-12 is a well-accepted short form of the well-known SF-36 quality of life instrument.
|
Baseline, 6, 12, 24
|
Change in weight loss strategies
Time Frame: Baseline, 6, 12, 24
|
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.
|
Baseline, 6, 12, 24
|
Change in endothelial function
Time Frame: Baseline, 6, 12, 24 months
|
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.
|
Baseline, 6, 12, 24 months
|
Change in self-efficacy to adhere to DASH-style dietary pattern
Time Frame: Baseline, 6, 12, 24 months
|
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.
|
Baseline, 6, 12, 24 months
|
Change in mental health status
Time Frame: Baseline, 6, 12, 24
|
Mental health index-5 (MHI-5) consists of 5 questionnaire items designed to assess emotional well-being.
|
Baseline, 6, 12, 24
|
Collaborators and Investigators
Investigators
- Principal Investigator: William J McCarthy, Ph.D., University of California, Los Angeles
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1P50HL105188-6094
- 1P50HL105188 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
Clinical Trials on Home environs-based lifestyle counseling
-
NYU Langone HealthAmerican Heart Association; UNITE HERE Health CenterTerminatedHigh Blood PressureUnited States
-
Hamilton Health Sciences CorporationHeart and Stroke Foundation of OntarioCompleted
-
University Health Network, TorontoCanadian Stroke NetworkCompleted
-
State University of New York at BuffaloCompletedOverweightUnited States
-
Duke UniversityDuke Cancer InstituteCompleted
-
University of Kansas Medical CenterCompleted
-
York UniversityPublic Health Agency of Canada (PHAC)Unknown
-
Case Western Reserve UniversityNational Institutes of Health (NIH); American Heart AssociationCompletedStroke | Multiple Sclerosis | Rheumatoid ArthritisUnited States
-
Aalborg University HospitalAarhus University Hospital; University of Aarhus; The Danish Cancer Foundation...Completed