ACTIVE_NOT_RECRUITING

Vida Sana y Completa Obesity and Food Insecurity Study

Conditions

Obesity food insecurity Latina fitbit Metabolic Diseases Chronic Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-09-27

Study Completion:2027-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05211180

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Lisa Goldman Rosas, PhD, MPH

PRINCIPAL_INVESTIGATOR

Stanford University

Wei-ting Chen, PhD

STUDY_DIRECTOR

Stanford University

Study Locations (Sites)

San Mateo Medical Center Fair Oaks Health Center

Redwood City, California, 94063

United States

Collaborators and Investigators

Sponsor: Stanford University

Lisa Goldman Rosas, PhD, MPH, PRINCIPAL_INVESTIGATOR, Stanford University
Wei-ting Chen, PhD, STUDY_DIRECTOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-27

Study Completion Date2027-10

Study Record Updates

Study Start Date2022-09-27

Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

obesity
food insecurity
Latina
fitbit
Metabolic Diseases
Chronic Disease

Additional Relevant MeSH Terms

Obesity