Vida Sana y Completa Obesity and Food Insecurity Study

Description

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.

Conditions

Obesity

Study Overview

Study Details

Study overview

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.

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

Vida Sana y Completa Obesity and Food Insecurity Study

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Redwood City

San Mateo Medical Center Fair Oaks Health Center, Redwood City, California, United States, 94063

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stanford University,

Lisa Goldman Rosas, PhD, MPH, PRINCIPAL_INVESTIGATOR, Stanford University

Wei-ting Chen, PhD, STUDY_DIRECTOR, Stanford University

Study Record Dates

2027-10