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NCT05211180Active, not recruiting

Vida Sana y Completa Obesity and Food Insecurity Study

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

Source: ClinicalTrials.gov · Last updated 14 Jul 2025

Brief summary (registry, in English)

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 while also collecting preliminary information on the potential for implementation and dissemination.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
412 (estimated)
First submitted
13 Jan 2022
Start date
27 Sept 2022
Primary completion date
Oct 2026
Lead sponsor
Stanford University
Diseases
Obesity
NCT number
NCT05211180

What you commit to

  • Study type: Interventional
  • Planned participants: 412
  • From 27 Sept 2022 to the primary completion date, Oct 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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:

Other illness

  • 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;

Other

  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
San Mateo Medical Center Fair Oaks Health Center
Coordinator of this site? Confirm its status
Redwood CityUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.