Cardiovascular DiseasesNCT01333241
Healthy Lifestyle Behavior Intervention for Latino Women
A study testing Lifestyle behavior interventon grop in people with Cardiovascular Diseases, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The overall goal of this randomized controlled trial is to evaluate the effects of a community-based lifestyle behavior intervention (LSBI) that is designed to improve dietary habits and physical activity (PA), and reduce weight of Latino women who are predominantly Spanish-speaking immigrants. Read more about this study
- Who is it for?
- Ages 35 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Lifestyle behavior interventon grop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 223 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jul 2012
- 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 35 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Latina
- 35 to 64 years of age
- body mass index (BMI) >25
- fluent in either Spanish or English.
Who cannot join
- pregnant or planning to get pregnant in next year
- history of myocardial infarction or stroke
- currently under treatment for cancer
- orthopedic or joint problems that would prohibit participation in physical activity
- insulin-dependent diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA School of Nursing
Los Angeles, California, 90095
About this study
Official title: Community-Based Lifestyle Promotion With Latino Women
The overall goal of this randomized controlled trial is to evaluate the effects of a community-based lifestyle behavior intervention (LSBI) that is designed to improve dietary habits and physical activity (PA), and reduce weight of Latino women who are predominantly Spanish-speaking immigrants. It is hypothesized that middle-aged overweight/obese Latinas participating in a LSBI conducted by lay health advisors will demonstrate improved dietary habits, increased physical activity and a decrease in BMI compared to those in a control condition, Women in the LSBI also are expected to demonstrate improvements in selected physiologic outcomes (waist circumference, blood pressure [BP], measures of cholesterol and blood sugar).
Read the detailed description
Overweight/obesity and physical inactivity are two significant predictors of illness and death from cardiovascular (heart) disease (CVD) in Latina adults. These risk factors may be reduced or eliminated through prevention efforts that focus on heart-healthy diets, weight reduction, and PA. The purpose of this study is to compare the effects of a 6-month community-based lifestyle behavior intervention (LSBI) conducted by lay health advisors and a control condition (disaster preparedness and home safety program) on lifestyle behaviors -dietary habits and physical activity(primary outcome) and selected physiologic outcomes (secondary outcomes) i.e., BMI, waist circumference, blood pressure, measures of cholesterol,and fasting blood sugar of Latinas who are overweight/obese. The LSBI includes group education (8 classes) and individual teaching and coaching (8 contacts by home visits and telephone calls) delivered over a 6-month period. Acceptability and feasibility of the intervention is evaluated through examination of women's retention rates and participation in classes and home visits.
- Conditions
- Cardiovascular Diseases
- Being tested
- Lifestyle behavior interventon grop, Placebo Comparator: Control group
- Keywords
- Hispanic/Latina Americans, Cardiovascular diseases, Obesity, Intervention
- Medical subject headings
- Cardiovascular Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle behavior interventon gropBehavioural
Placebo Comparator: Control groupOther
Also called Disaster Preparedness/Home Safety
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle behavior intervention group | Experimental | The 6-month lifestyle behavior intervention includes group education and individual teaching and coaching. Receives: Behavioral: Lifestyle behavior interventon grop |
| Control group | Sham comparator | Disaster Preparedness/Home Safety group education and teaching Receives: Other: Placebo Comparator: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body mass index (BMI)
Measured: Baseline, 6 and 9 month follow-up.
Secondary outcomes (3)
Change in Physical Activity
Physical activity as determined by accelerometer readings,
Measured: Baseline, 6 and 9 month follow-up
Change in Physiologic measures
Blood pressure, cholesterol (total, HDL, LDL, and triglycerides), fasting blood sugar, and waist circumference.
Measured: Baseline, 6 and 9 month follow-up.
Change in Lifestyle behaviors
Self-reported eating and physical activity.
Measured: Baseline, 6 and 9 month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startAug 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Deborah Koniak-Griffin, University of California, Los Angeles
- Investigators
- Deborah Koniak-Griffin, RNC, EdD, Principal investigator, UCLA School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333241
- Sponsor's protocol ID
- G090405102
- Other IDs
- R01HL086931-A1, R01HL086931
- Status last verified
- Nov 2019
- First submitted
- 6 Apr 2011
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Koniak-Griffin, D., Brecht, M. L., Takayanagi, S., Villegas, J., Melendrez, M., & Balcázar, H. (2014). A community health worker-led lifestyle behavior intervention for Latina (Hispanic) women: Feasibility and outcomes of a randomized controlled trial. International journal of nursing studies. Koniak-Griffin, D., & Brecht, M.-L. (2014, July 30). Awareness of Cardiovascular Disease and Preventive Behaviors Among Overweight Immigrant Latinas. Journal of Cardiovascular Nursing [Epub ahead of print] Koniak-Griffin, D., Brecht, M. L., Takayanagi, S., Villegas, J., & Melendrez, M. (2013). Physical Activity and Cardiometabolic Characteristics in Overweight Latina Women. Journal of Immigrant and Minority Health, 1-9.
Koniak-Griffin D, Brecht ML, Takayanagi S, Villegas J, Melendrez M, Balcazar H. A community health worker-led lifestyle behavior intervention for Latina (Hispanic) women: feasibility and outcomes of a randomized controlled trial. Int J Nurs Stud. 2015 Jan;52(1):75-87. doi: 10.1016/j.ijnurstu.2014.09.005. Epub 2014 Sep 22.
PubMed 25307195Koniak-Griffin D, Brecht ML, Takayanagi S, Villegas J, Melendrez M. Physical activity and cardiometabolic characteristics in overweight Latina women. J Immigr Minor Health. 2014 Oct;16(5):856-64. doi: 10.1007/s10903-013-9782-z.
PubMed 23355122
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Lifestyle Promotion With Latino Women
- ClinicalTrials.gov ID
- NCT01333241
- Acronym / sponsor ID
- G090405102
- Conditions
- Cardiovascular Diseases
- Keywords
- Hispanic/Latina Americans, Cardiovascular diseases, Obesity, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 11 Apr 2011 (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.
The overall goal of this randomized controlled trial is to evaluate the effects of a community-based lifestyle behavior intervention (LSBI) that is designed to improve dietary habits and physical activity (PA), and reduce weight of Latino women who are predominantly Spanish-speaking immigrants. It is hypothesized that middle-aged overweight/obese Latinas participating in a LSBI conducted by lay health advisors will demonstrate improved dietary habits, increased physical activity and a decrease in BMI compared to those in a control condition, Women in the LSBI also are expected to demonstrate improvements in selected physiologic outcomes (waist circumference, blood pressure [BP], measures of cholesterol and blood sugar).
Detailed description
Overweight/obesity and physical inactivity are two significant predictors of illness and death from cardiovascular (heart) disease (CVD) in Latina adults. These risk factors may be reduced or eliminated through prevention efforts that focus on heart-healthy diets, weight reduction, and PA. The purpose of this study is to compare the effects of a 6-month community-based lifestyle behavior intervention (LSBI) conducted by lay health advisors and a control condition (disaster preparedness and home safety program) on lifestyle behaviors -dietary habits and physical activity(primary outcome) and selected physiologic outcomes (secondary outcomes) i.e., BMI, waist circumference, blood pressure, measures of cholesterol,and fasting blood sugar of Latinas who are overweight/obese. The LSBI includes group education (8 classes) and individual teaching and coaching (8 contacts by home visits and telephone calls) delivered over a 6-month period. Acceptability and feasibility of the intervention is evaluated through examination of women's retention rates and participation in classes and home visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle behavior intervention group | Experimental | Behavioral: Lifestyle behavior interventon gropThe 6-month lifestyle behavior intervention includes group education and individual teaching and coaching. |
| Control group | Sham comparator | Other: Placebo Comparator: Control groupDisaster Preparedness/Home Safety group education and teaching |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Latina
- 35 to 64 years of age
- body mass index (BMI) >25
- fluent in either Spanish or English.
Key exclusion criteria (5 listed)
- pregnant or planning to get pregnant in next year
- history of myocardial infarction or stroke
- currently under treatment for cancer
- orthopedic or joint problems that would prohibit participation in physical activity
- insulin-dependent diabetes
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 |
|---|---|---|
| Lifestyle behavior interventon grop | Behavioural | Lifestyle behavior intervention group |
| Placebo Comparator: Control groupAlso: Disaster Preparedness/Home Safety | Other | Control group |
Primary outcome
Change in Body mass index (BMI)
Time frame: Baseline, 6 and 9 month follow-up.
3 secondary outcomes
Change in Physical Activity
Time frame: Baseline, 6 and 9 month follow-up
Change in Physiologic measures
Time frame: Baseline, 6 and 9 month follow-up.
Change in Lifestyle behaviors
Time frame: Baseline, 6 and 9 month follow-up.
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 7 Nov 2019.
- BackgroundKoniak-Griffin, D., Brecht, M. L., Takayanagi, S., Villegas, J., Melendrez, M., & Balcázar, H. (2014). A community health worker-led lifestyle behavior intervention for Latina (Hispanic) women: Feasibility and outcomes of a randomized controlled trial. International journal of nursing studies. Koniak-Griffin, D., & Brecht, M.-L. (2014, July 30). Awareness of Cardiovascular Disease and Preventive Behaviors Among Overweight Immigrant Latinas. Journal of Cardiovascular Nursing [Epub ahead of print] Koniak-Griffin, D., Brecht, M. L., Takayanagi, S., Villegas, J., & Melendrez, M. (2013). Physical Activity and Cardiometabolic Characteristics in Overweight Latina Women. Journal of Immigrant and Minority Health, 1-9.
- Derived from this study: PubMed 25307195Koniak-Griffin D, Brecht ML, Takayanagi S, Villegas J, Melendrez M, Balcazar H. A community health worker-led lifestyle behavior intervention for Latina (Hispanic) women: feasibility and outcomes of a randomized controlled trial. Int J Nurs Stud. 2015 Jan;52(1):75-87. doi: 10.1016/j.ijnurstu.2014.09.005. Epub 2014 Sep 22.
- Derived from this study: PubMed 23355122Koniak-Griffin D, Brecht ML, Takayanagi S, Villegas J, Melendrez M. Physical activity and cardiometabolic characteristics in overweight Latina women. J Immigr Minor Health. 2014 Oct;16(5):856-64. doi: 10.1007/s10903-013-9782-z.
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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.
Deborah Koniak-Griffin, RNC, EdD principal investigator
UCLA School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle behavior interventon grop in people with Cardiovascular Diseases, 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 4 inclusion and 5 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 7 Nov 2019. 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. Some participants in this study may receive a placebo. 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?
Change in Body mass index (BMI) (time frame: Baseline, 6 and 9 month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01333241, which also lists 3 linked publications.
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 7 Nov 2019.