Addressing obesity and food insecurity among Latina women

Vida Sana y Completa Trial: Treating Obesity and Food Insecurity Among Latina Women

This study is testing two different ways to help Latina women who are struggling with obesity and food insecurity to see which one helps them lose weight and eat healthier.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 412 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Stanford University (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Redwood City, California)
• Trial ID: NCT05211180 on ClinicalTrials.gov

What this trial studies

The Vida Sana y Completa study aims to evaluate two different approaches to tackle obesity and food insecurity in Latina women receiving primary care. It will recruit 412 low-income Latina women with obesity and food insecurity from community health centers, randomly assigning them to either an integrated obesity intervention with food support or a standard obesity program. The study will assess the effectiveness of these interventions in promoting weight loss and improving dietary habits through the provision of healthy food options. This research seeks to provide valuable insights for community health centers serving this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates for this study are low-income Latina women aged 18 and older with a body mass index of 30 or higher and experiencing food insecurity.

Not a fit: Patients who do not identify as Latina or who have a body mass index below 30 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved health outcomes for Latina women by effectively addressing both obesity and food insecurity.

How similar studies have performed: Other studies have shown promise in addressing obesity and food insecurity through integrated interventions, making this approach both relevant and potentially impactful.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Redwood City, California

• San Mateo Medical Center Fair Oaks Health Center — Redwood City, California, United States (RECRUITING)

Study contacts

• Principal investigator: Lisa Goldman Rosas, PhD, MPH — Stanford University
• Study coordinator: Michelle Ordonez Arango

Conditions: Obesity, obesity, food insecurity, Latina, fitbit, Metabolic Diseases, Chronic Disease