Clinical trial NCT05211180: Vida Sana y Completa Obesity and Food Insecurity Study
Official title: Vida Sana y Completa Trial: Treating Obesity and Food Insecurity Among Latina Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: obesity
food insecurity
Latina
fitbit
Metabolic Diseases
Chronic Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: San Mateo Medical Center
First posted: 2022-01-27
Enrollment: 412
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study uses a type 1 hybrid design with participants randomized in a 1:1 ratio to either Vida Sana y Completa (an obesity intervention with integrated treatment for food insecurity) or Vida Sana alone (the comparator arm). Vida Sana is a cultural-adaption of Group Lifestyle Balance, a 12-month intervention that targets at least 5% weight loss and at least 150 minutes per week of moderate-to-vigorous physical activity.
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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-priority group. The project team will recruit 412 low-income Latina women with obesity (body mass index 30) and food insecurity from two community health centers with whom the team has longstanding partnerships. Patients will be randomized to Vida Sana y Completa (an obesity intervention with integrated treatment for food insecurity) or Vida Sana alone. Vida Sana is a state-of-the-art cultural adaptation of Group Lifestyle Balance, a 12-month program that targets at least 5 percent weight loss and at least 150 minutes per week of moderate-to-vigorous physical activity. For food insecurity, the team will provide boxes of healthy foods (e.g., fresh produce, lean protein, low-fat dairy, and whole grains) that give women the foods they need to adopt a healthy diet.

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

Primary outcomes:
measure: Weight change (12 months)
timeFrame: Baseline, 12 months, 24 months
Secondary outcomes:
measure: Self-reported weight
timeFrame: 6 months, 18 months
measure: Visit or EHR Height, Weight, and Waist Circumference
timeFrame: baseline, 12 months, 24 months
measure: Health-related quality of life
timeFrame: baseline, 6 months, 12 months, 24 months
measure: Obesity-specific quality of life
timeFrame: baseline, 6 months, 12 months, 24 months
measure: Change in Psychosocial Well-being: Depressive Symptoms
timeFrame: baseline, 6 months, 12 months, 24 months
measure: Cardiometabolic risk factors
timeFrame: baseline, 6 months, 12 months, 24 months
measure: Participant Medication Usage
timeFrame: baseline, 12 months, 24 months
measure: Dietary Intake Patterns
timeFrame: baseline, 6 months, 12 months, 24 months
measure: Food Neophobia Scale
timeFrame: baseline, 6 months, 12 months, 24 months
measure: Food Attitudes & Behaviors (FAB) Scale for self-efficacy
timeFrame: baseline, 6 months, 12 months, 24 months
measure: Second Harvest of Silicon Valley Food Bank Self-Efficacy Measure
timeFrame: baseline, 6 months, 12 months, 24 months
measure: Participant self-reported 7-day Physical Activity Recall
timeFrame: baseline, 6 months, 12 months, 24 months
measure: Participant steps per day
timeFrame: baseline, 6 months, 12 months, 18 months, 24 months
measure: Number of participants with food insecurity
timeFrame: baseline, 6 months, 12 months, 18 months, 24 months
measure: Self-reported Nutrition Security, Healthfulness Control, and Utilization Barriers Survey Tool
timeFrame: baseline, 6 months, 12 months, 18 months, 24 months
measure: Stunkard Figure Rating Scale
timeFrame: baseline
measure: Level of anxiety among participants
timeFrame: baseline, 6 months, 12 months, 24 months
measure: Bidimensional Acculturation Scale for Hispanics
timeFrame: baseline
measure: COVID-19 Impact on Health and Wellbeing Survey for Health Literacy
timeFrame: baseline
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: San Mateo Medical Center Fair Oaks Health Center
state: California
Study officials:
affiliation: Stanford University
name: Lisa Goldman Rosas, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Wei-ting Chen, PhD
role: STUDY_DIRECTOR
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