Status:
ACTIVE_NOT_RECRUITING
Vida Sana y Completa Obesity and Food Insecurity Study
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
San Mateo Medical Center
Conditions:
Obesity
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The goal of the Vida Sana y Completa study is to provide evidence on the most effective approach for addressing the critical combination of obesity and food insecurity among Latinas in primary care wh...
Detailed Description
The goal of this study is to compare two approaches to addressing obesity and food insecurity among Latina women in primary care to provide evidence for community health centers who serve this high-pr...
Eligibility Criteria
Inclusion
- Age: Lower age limit - 18 years, Upper age limit - NONE
- Race/ethnicity: self-reported Latinx ethnicity
- Sex: Female
- Body mass index: ≥ 30 kg/m2
- One or more metabolic risk factors as follows:
- Fasting plasma glucose of 100 to 125 mg/dL or HbA1c of 5.7 to 6.4 if detected by a recent (within the past year), documented, blood-based diagnostic test in the Electronic Health Record (EHR) in the last year
- Waist circumference \>40 inches in men and \>35 inches in women (≥35 inches in men and ≥31 inches in women, if of Asian descent) as measured by the study coordinator
- Triglycerides \>150 mg/dL as documented in the EHR in the last year
- High-density lipoprotein cholesterol (HDL-C) \<40 mg/dL in men and \<50 mg/dL in women as documented in the EHR in the last year
- Systolic blood pressure \>120 mmHg or diastolic blood pressure \>80 mmHg as measured by study coordinator
- Food insecurity: Defined as answering yes to one or both questions of the Hunger Vital Sign
- PCP approval of patient contact for study screening
- Able and willing to enroll and provide informed consent, i.e., to meet the time and data collection requirements of the study, be randomized to one of 2 study arms, participate for 24 months, and authorize extraction of relevant information from the EHR.
Exclusion
- Previous diagnosis of diabetes (other than during pregnancy) or diabetes documented in the EHR
- Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 2 years
- Serious medical condition anticipated to prevent person from walking
- 1 mile (e.g., severe pulmonary disease or aortic stenosis)
- Severe medical comorbidities that require aggressive treatment: e.g., stage 4 or greater renal disease, class III or greater heart failure, unstable coronary artery disease, liver or renal failure;
- Diagnosis of a terminal illness and/or in hospice care;
- Diagnosis of bipolar disorder or psychotic disorder within the last 2 years, or currently taking a mood stabilizer or antipsychotic medication
- Initiation or change in type or dosing of antidepressant medications within 2 months prior to enrollment (The patient will be re-contacted for a later cohort once his/her regimen has been stable for at least 2 months unless the person declines to participate altogether.)
- Have had or plan to undergo bariatric surgery during the study period
- Other exclusions:
- Inability to speak, read or understand Spanish
- Having no reliable telephone service
- Having no regular Internet access via a computer and/or mobile device (e.g., smartphone)
- Plan to move out of the area during the study period
- Planned pregnancy
- Family/household member of another study participant or of a study staff member
- Investigator discretion for clinical safety or protocol adherence reasons
Key Trial Info
Start Date :
September 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT05211180
Start Date
September 27 2022
End Date
October 1 2027
Last Update
July 14 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
San Mateo Medical Center Fair Oaks Health Center
Redwood City, California, United States, 94063