ObesityPhase 2VAFONCT01242683
Vivamos Activos Fair Oaks Program for Weight Loss in Low Income Latinos
A Phase 2 study testing Vivamos Activos Fair Oaks Program in people with Obesity, run by Stanford University at 4 sites in United States.
Trial summary
Physician-based primary care has thus far failed to address the obesity epidemic. In this randomized clinical trial of 200 obese patients with heart disease risk factors, the investigators will evaluate the impact of nurse and dietitian case management on weight loss and weight maintenance, as an adjunct to physician… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Vivamos Activos Fair Oaks Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2008to Oct 2013
- 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
- Age 18 years or older;
- Body mass between 30 and 55 kg/m2
- One or more CHD risk factors: Systolic blood pressure between 130 and 200 mmHg; Diastolic blood pressure between 80 and 105 mmHg; Total cholesterol > 180 mg/dL; LDL cholesterol > 120 mg/dL; HDL Cholesterol < 40 mg/dL; Triglycerides > 150 mg/dL; HbA1c between 6.0 and 11.5%; Fasting plasma glucose between 95 and 400 mg/dL; Diagnosis of Type 2 diabetes
- Residing in catchment area of the Fair Oaks Adult Clinic and receiving primary care at Fair Oaks Adult Clinic.
Who cannot join
- Inability to speak Spanish;
- Unwilling to attempt weight loss;
- Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, diabetes, renal, liver), unstable heart disease, advanced heart failure, and ongoing substance abuse;
- On greater than 10 prescription medications;
- Psychiatric disorders requiring antipsychotics or multiple medications;
- Body weight change > 25 lbs. in the preceding 3 months;
Show all 13Show fewer
- Pregnant, planning to become pregnant, or lactating less than six months;
- Family household member already enrolled in the study;
- Intends to or is enrolled in a study that would limit full participation in VAFO;
- Participants who are unwilling to have home visits by study staff;
- Resident of a long term care facility;
- Plans to move during the study period (24 months post-randomization);
- Investigator discretion for clinical safety or adherence reasons (e.g., unstable housing, chronic pain).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Palo Alto Medical Foundation Research Institute
Palo Alto, California, 94301
San Mateo Medical Center, Fair Oaks Adult Clinic
Redwood City, California, 94025
El Concilio of San Mateo
San Mateo, California, 94010-4123
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Case-Management & Environmental Support to Sustain Weight Loss & Reduce CHD Risk
Physician-based primary care has thus far failed to address the obesity epidemic. In this randomized clinical trial of 200 obese patients with heart disease risk factors, the investigators will evaluate the impact of nurse and dietitian case management on weight loss and weight maintenance, as an adjunct to physician care. In addition, the investigators will test the incremental benefit of an environmental support strategy using community health workers to help patients navigate their home and neighborhood environments to achieve weight loss. The innovative intervention model developed and evaluated in this project has the potential to provide a blueprint for successful primary care-based obesity services
Read the detailed description
Obesity is an epidemic in the U.S., with a third of adults obese. Obesity exerts enormous impact on the nation's health and economy largely through its effect on coronary heart disease (CHD) risk factors: 3 in 4 obese Americans have at least one CHD risk factor reversible through weight loss. Working within acute care-centered systems, most clinicians are unsuccessful in helping their patients lose weight or prevent weight gain. A promising and well-studied approach is integrated care delivered by nurse and dietitian case managers (CMs). Nonetheless, clinical prevention services (including CM) may be less effective if provided in isolation from patients' living environments that so often reinforce caloric excess and physical inactivity.
This application leverages our extensive expertise in developing and disseminating effective CM programs (Heart to Heart, R01 HL070781). We will implement an obesity-focused CM program that focuses on established behavioral weight loss and maintenance strategies and evidence-based CHD prevention targets. We also will test the additional benefit of structured "environmental support" (ES) carried out by community health workers that will bridge the gap between the clinic and patients' homes and neighborhood. Our Specific Aims are to:
- Implement innovative, primary care-based CM and CM+ES interventions in a randomized clinical trial. We will conduct this trial at a San Mateo Medical Center (SMMC) health center serving an ethnically diverse, low-income population. We will randomize 200 obese adults with at least one obesity-related CHD risk factor over 18 months to usual primary care (40 patients), CM alone (80), or CM+ES (80). Intervention patients in will receive an intensive weight loss and CHD risk intervention for 12 months, followed by 12 months of maintenance intervention.
- Determine the effectiveness and cost-effectiveness of the CM and CM+ES for improving BMI and CHD risk factors, relative to usual care and each other. Our PRIMARY HYPOTHESIS is that patients managed through CM+ES will experience greater reductions in BMI over 24-months than those in CM.
- Transition the favored intervention to a sustainable program, supported by the County, as well as explore opportunities for broader dissemination to other County and non-County systems. A business case for dissemination based on our findings will be critical in seeking this investment.
This project will develop and test two novel models of care design to support sustained weight loss. Given the failure of current mechanisms to address obesity and elevated CHD risk, these models have the potential to provide a blueprint for primary care-based obesity services that can reduce this nation's burden of obesity, especially for low-income populations.
- Conditions
- Obesity
- Being tested
- Vivamos Activos Fair Oaks Program
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivamos Activos Fair Oaks ProgramBehavioural
Also called Modified and Tailored Diabetes Prevention Program Protocol
Comparison of Case-management vs. Case-management plus Home Visits vs. Usual Primary Care.
Case-management: Five 60 minute individual and 15 90 minute group sessions devoted to behavioral strategies to facilitate weight loss conducted by a health educator.
Home-visits: Seven home visits provided by a community health worker to provide life-style/environmental support for behavior change to facilitate weight loss.
Usual primary care: Usual care provided at health center that is available to participants in all three study arms.
| Study group | Role | What they receive |
|---|---|---|
| Case-Management for Behavior Change | Experimental | Individual and group sessions devoted to behavioral strategies to facilitate weight loss conducted by a health educator. 12 month of intensive intervention followed by 12 months of maintenance intervention. Receives: Behavioral: Vivamos Activos Fair Oaks Program |
| Case-Management plus Home Visits | Experimental | Community health worker lifestyle support for weight loss strategies conducted in participants' homes and neighborhood. Also, receive individual and group sessions devoted to behavioral strategies to facilitate weight loss conducted by a health educator. 12 month of intensive intervention followed by 12 months of maintenance intervention. Receives: Behavioral: Vivamos Activos Fair Oaks Program |
| Usual Primary Care | Placebo comparator | Continuation of usual primary care managed by the participants' usual physician or nurse practitioner source of care. Receives: Behavioral: Vivamos Activos Fair Oaks Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass index
Measured: 24 months
Secondary outcomes (4)
blood lipid measurements
Measured: 24 months
Fasting blood glucose
Measured: 24 months
triglycerides
Measured: 24 months
Hemoglobin A1c
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startMay 2008
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- San Mateo Medical Center, El Concilio of San Mateo County, Palo Alto Medical Foundation, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Randall Stafford, Stanford University
- Investigators
- Randall S. Stafford MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242683
- Sponsor's protocol ID
- SU-10112010-7069
- Other IDs
- R01HL089448
- Acronym
- VAFO
- Status last verified
- May 2014
- First submitted
- 15 Nov 2010
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Drieling RL, Ma J, Stafford RS. Evaluating clinic and community-based lifestyle interventions for obesity reduction in a low-income Latino neighborhood: Vivamos Activos Fair Oaks Program. BMC Public Health. 2011 Feb 14;11:98. doi: 10.1186/1471-2458-11-98.
PubMed 21320331Drieling RL, Goldman Rosas L, Ma J, Stafford RS. Community resource utilization, psychosocial health, and sociodemographic factors associated with diet and physical activity among low-income obese Latino immigrants. J Acad Nutr Diet. 2014 Feb;114(2):257-265. doi: 10.1016/j.jand.2013.07.025. Epub 2013 Oct 8.
PubMed 24119533
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case-Management & Environmental Support to Sustain Weight Loss & Reduce CHD Risk
- ClinicalTrials.gov ID
- NCT01242683
- Acronym / sponsor ID
- VAFO / SU-10112010-7069
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- San Mateo Medical Center, El Concilio of San Mateo County, Palo Alto Medical Foundation, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2008
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 17 Nov 2010 (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.
Physician-based primary care has thus far failed to address the obesity epidemic. In this randomized clinical trial of 200 obese patients with heart disease risk factors, the investigators will evaluate the impact of nurse and dietitian case management on weight loss and weight maintenance, as an adjunct to physician care. In addition, the investigators will test the incremental benefit of an environmental support strategy using community health workers to help patients navigate their home and neighborhood environments to achieve weight loss. The innovative intervention model developed and evaluated in this project has the potential to provide a blueprint for successful primary care-based obesity services
Detailed description
Obesity is an epidemic in the U.S., with a third of adults obese. Obesity exerts enormous impact on the nation's health and economy largely through its effect on coronary heart disease (CHD) risk factors: 3 in 4 obese Americans have at least one CHD risk factor reversible through weight loss. Working within acute care-centered systems, most clinicians are unsuccessful in helping their patients lose weight or prevent weight gain. A promising and well-studied approach is integrated care delivered by nurse and dietitian case managers (CMs). Nonetheless, clinical prevention services (including CM) may be less effective if provided in isolation from patients' living environments that so often reinforce caloric excess and physical inactivity.
This application leverages our extensive expertise in developing and disseminating effective CM programs (Heart to Heart, R01 HL070781). We will implement an obesity-focused CM program that focuses on established behavioral weight loss and maintenance strategies and evidence-based CHD prevention targets. We also will test the additional benefit of structured "environmental support" (ES) carried out by community health workers that will bridge the gap between the clinic and patients' homes and neighborhood. Our Specific Aims are to:
- Implement innovative, primary care-based CM and CM+ES interventions in a randomized clinical trial. We will conduct this trial at a San Mateo Medical Center (SMMC) health center serving an ethnically diverse, low-income population. We will randomize 200 obese adults with at least one obesity-related CHD risk factor over 18 months to usual primary care (40 patients), CM alone (80), or CM+ES (80). Intervention patients in will receive an intensive weight loss and CHD risk intervention for 12 months, followed by 12 months of maintenance intervention.
- Determine the effectiveness and cost-effectiveness of the CM and CM+ES for improving BMI and CHD risk factors, relative to usual care and each other. Our PRIMARY HYPOTHESIS is that patients managed through CM+ES will experience greater reductions in BMI over 24-months than those in CM.
- Transition the favored intervention to a sustainable program, supported by the County, as well as explore opportunities for broader dissemination to other County and non-County systems. A business case for dissemination based on our findings will be critical in seeking this investment.
This project will develop and test two novel models of care design to support sustained weight loss. Given the failure of current mechanisms to address obesity and elevated CHD risk, these models have the potential to provide a blueprint for primary care-based obesity services that can reduce this nation's burden of obesity, especially for low-income populations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Case-Management for Behavior Change | Experimental | Behavioral: Vivamos Activos Fair Oaks ProgramIndividual and group sessions devoted to behavioral strategies to facilitate weight loss conducted by a health educator. 12 month of intensive intervention followed by 12 months of maintenance intervention. |
| Case-Management plus Home Visits | Experimental | Behavioral: Vivamos Activos Fair Oaks ProgramCommunity health worker lifestyle support for weight loss strategies conducted in participants' homes and neighborhood. Also, receive individual and group sessions devoted to behavioral strategies to facilitate weight loss conducted by a health educator. 12 month of intensive intervention followed by 12 months of maintenance intervention. |
| Usual Primary Care | Placebo comparator | Behavioral: Vivamos Activos Fair Oaks ProgramContinuation of usual primary care managed by the participants' usual physician or nurse practitioner source of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older;
- Body mass between 30 and 55 kg/m2
- One or more CHD risk factors: Systolic blood pressure between 130 and 200 mmHg; Diastolic blood pressure between 80 and 105 mmHg; Total cholesterol > 180 mg/dL; LDL cholesterol > 120 mg/dL; HDL Cholesterol < 40 mg/dL; Triglycerides > 150 mg/dL; HbA1c between 6.0 and 11.5%; Fasting plasma glucose between 95 and 400 mg/dL; Diagnosis of Type 2 diabetes
- Residing in catchment area of the Fair Oaks Adult Clinic and receiving primary care at Fair Oaks Adult Clinic.
Key exclusion criteria (13 listed)
- Inability to speak Spanish;
- Unwilling to attempt weight loss;
- Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, diabetes, renal, liver), unstable heart disease, advanced heart failure, and ongoing substance abuse;
- On greater than 10 prescription medications;
- Psychiatric disorders requiring antipsychotics or multiple medications;
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 |
|---|---|---|
| Vivamos Activos Fair Oaks ProgramAlso: Modified and Tailored Diabetes Prevention Program ProtocolComparison of Case-management vs. Case-management plus Home Visits vs. Usual Primary Care. Case-management: Five 60 minute individual and 15 90 minute group sessions devoted to behavioral strategies to facilitate weight loss conducted by a health educator. Home-visits: Seven home visits provided by a community health worker to provide life-style/environmental support for behavior change to facilitate weight loss. Usual primary care: Usual care provided at health center that is available to participants in all three study arms. | Behavioural | Case-Management for Behavior Change, Case-Management plus Home Visits, Usual Primary Care |
Primary outcome
body mass index
Time frame: 24 months
4 secondary outcomes
blood lipid measurements
Time frame: 24 months
Fasting blood glucose
Time frame: 24 months
triglycerides
Time frame: 24 months
Hemoglobin A1c
Time frame: 24 months
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 Jun 2014.
- Background: PubMed 21320331Drieling RL, Ma J, Stafford RS. Evaluating clinic and community-based lifestyle interventions for obesity reduction in a low-income Latino neighborhood: Vivamos Activos Fair Oaks Program. BMC Public Health. 2011 Feb 14;11:98. doi: 10.1186/1471-2458-11-98.
- Derived from this study: PubMed 24119533Drieling RL, Goldman Rosas L, Ma J, Stafford RS. Community resource utilization, psychosocial health, and sociodemographic factors associated with diet and physical activity among low-income obese Latino immigrants. J Acad Nutr Diet. 2014 Feb;114(2):257-265. doi: 10.1016/j.jand.2013.07.025. Epub 2013 Oct 8.
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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.
Randall S. Stafford MD, PhD principal investigator
Stanford University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vivamos Activos Fair Oaks Program in people with Obesity, run by Stanford University at 4 sites 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 13 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 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
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?
body mass index (time frame: 24 months). 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 NCT01242683, which also lists 2 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 2 Jun 2014.