Vida Sana y Completa Obesity and Food Insecurity Study

NCT05211180 | Active Not Recruiting

• 1 other identifier: 63206
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

obesity; food insecurity; Latina; fitbit; Metabolic Diseases; Chronic Disease

Outcome Measures

Primary Outcomes (1)

• Weight change (12 months)

  Trained research assistants blinded to treatment assignment will weigh participants in duplicate using a standard calibrated scale at baseline, 12, and 24 months

  Baseline, 12 months, 24 months

Secondary Outcomes (19)

• Self-reported weight

  6 months, 18 months

• Visit or EHR Height, Weight, and Waist Circumference

  baseline, 12 months, 24 months

• Health-related quality of life

  baseline, 6 months, 12 months, 24 months

• Obesity-specific quality of life

  baseline, 6 months, 12 months, 24 months

• Change in Psychosocial Well-being: Depressive Symptoms

  baseline, 6 months, 12 months, 24 months

Study Arms (2)

Vida Sana

ACTIVE COMPARATOR

Vida Sana is a cultural-adaption of Group Lifestyle Balance, a 12-month intervention that targets at least 5% weight loss and at least150 minutes per week of moderate-to-vigorous physical activity. Health coaches will facilitate 12 weekly 1-hour group education sessions, followed by nine 30-45 minute individual monthly phone sessions. Health coaches will also conduct two home visits (at baseline and 12-weeks post-enrollment). The health coach will review participant's fitbit health tracking data with them and give personalized feedback.

Behavioral: Vida Sana

Vida Sana y Completa

EXPERIMENTAL

Vida Sana y Completa is an obesity intervention with integrated treatment for food insecurity. This arm includes all the activities described for the active comparator arm (Vida Sana) as well as a weekly food box delivery for the first 12 weeks of the intervention. The food box will contain approximately 40 pounds of food including proteins and dairy, whole grains, and produce. Just like the Vida Sana active comparator arm, the Vida Sana y Completa group will include health coaches who will facilitate 12 weekly 1-hour group education sessions, followed by nine 30-45 minute individual monthly phone sessions. Health coaches will also conduct two home visits (at baseline and 12-weeks post-enrollment). The health coach will review participant's fitbit health tracking data with them and give personalized feedback.

Behavioral: Vida Sana y Completa

Interventions

Vida Sana BEHAVIORAL

Weekly group or individual education sessions with a health coach and fitness tracking with a fitbit.

Vida Sana

Vida Sana y Completa BEHAVIORAL

Weekly group or individual education sessions with a health coach, fitness tracking with a fitbit, and weekly food box delivery.

Vida Sana y Completa

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Stanford University: lead
• Patient-Centered Outcomes Research Institute: collaborator
• San Mateo Medical Center: collaborator

Study Sites (1)

San Mateo Medical Center Fair Oaks Health Center

Redwood City, California, 94063, United States

Location

Related Publications (5)

• Straub SX, Garry RF, Magee WE. Interferon induction by poly (I): poly (C) enclosed in phospholipid particles. Infect Immun. 1974 Oct;10(4):783-92. doi: 10.1128/iai.10.4.783-792.1974.

  PMID: 4426708 BACKGROUND

• Conzelmann E, Sandhoff K. The specificity of human N-acetyl-beta-D-hexosaminidases towards glycosphincolipids is determined by an activator protein. Adv Exp Med Biol. 1980;125:295-306. doi: 10.1007/978-1-4684-7844-0_27.

  PMID: 6444774 BACKGROUND

• Copeland MM. American Joint Committee on Cancer Staging and end results reporting. Objectives and progress. Cancer. 1965 Dec;18(12):1637-40. doi: 10.1002/1097-0142(196512)18:123.0.co;2-c. No abstract available.

  PMID: 5845801 BACKGROUND

• Pliner P, Hobden K. Development of a scale to measure the trait of food neophobia in humans. Appetite. 1992 Oct;19(2):105-20. doi: 10.1016/0195-6663(92)90014-w.

  PMID: 1489209 BACKGROUND

• Thompson, J.K., & Altabe, M.N. (1991). Psychometric qualities of the figure rating scale. International Journal of Eating Disorders, 10(5), 615-619.

  BACKGROUND

Related Links

• Food Attitudes and Behaviors (FAB) from NIH
• National Health and Nutrition Examination Surveys (NHANES) Anthropometry Procedures Manual

MeSH Terms

Conditions

Obesity; Metabolic Diseases; Chronic Disease

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Lisa Goldman Rosas, PhD, MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

• Wei-ting Chen, PhD

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will know which group they have been randomized to. The investigator and statistician will not know which group a participant belongs to. Group identifiers will be removed prior to analysis.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor, Department of Health Research and Policy (Epidemiology) and Medicine (Primary Care and Population Health) Faculty Director, Office of Community Engagement Stanford School of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 27, 2022
• Study Start: September 27, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)