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ObesityNCT05211180

Vida Sana y Completa Obesity and Food Insecurity Study

A study testing Vida Sana and Vida Sana y Completa in people with Obesity, run by Stanford University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Obesity
What is being tested?
Vida Sana and Vida Sana y Completa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
412 participants
Where
1 siteUnited States
Study dates
27 Sep 2022to Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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.

Who cannot join

  • 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;
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • San Mateo Medical Center Fair Oaks Health Center

    Redwood City, California, 94063

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Obesity
Being tested
Vida Sana, Vida Sana y Completa
Keywords
obesity, food insecurity, Latina, fitbit, Metabolic Diseases, Chronic Disease
Medical subject headings
Obesity, Metabolic Diseases, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vida SanaBehavioural

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

  • Vida Sana y CompletaBehavioural

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

Study groups in NCT05211180
Study groupRoleWhat they receive
Vida SanaActive comparatorVida 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.
Receives: Behavioral: Vida Sana
Vida Sana y CompletaExperimentalVida 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.
Receives: Behavioral: Vida Sana y Completa

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline, 12 months, 24 months

Secondary outcomes (19)
  1. Self-reported weight

    Participants will self-report measures of weight at 6 and 18 months to the health coach via telephone.

    Measured: 6 months, 18 months

  2. Visit or EHR Height, Weight, and Waist Circumference

    In person visits at baseline, 12-months and 24-months post enrollment will be used to collect participant weight, height and waist circumference. At baseline, these will be measured twice or in triplicate if there is a discrepancy. Height will be measured in centimeters, weight will be measured in kilograms, and waist circumference will be recorded in centimeters. If participants cannot be weighed in person for the primary outcome, weight measurement from the EHR if available within 3 months of the data collection date will be used.

    Waist circumference will be measured according to standard protocols described by the National Health and Nutrition Examination Surveys (NHANES) Anthropometry Procedures Manual. http://www.cdc.gov/nchs/data/nhanes/nhanes_11_12/Anthropometry_Procedures_Manual.pdf. Published 2011.

    Measured: baseline, 12 months, 24 months

  3. Health-related quality of life

    The validated SF-8™ will be used. It is a generic multipurpose short-form health-related quality of life instrument and was developed by the RAND Corporation and the Medical Outcomes Study (MOS) in the 1980s.

    Measured: baseline, 6 months, 12 months, 24 months

  4. Obesity-specific quality of life

    Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems. Obesity-related quality of life measured at baseline, 6 months, 12 months and at 24 months.

    Measured: baseline, 6 months, 12 months, 24 months

  5. Change in Psychosocial Well-being: Depressive Symptoms

    The Patient Health Questionnaire PHQ-9 is a self-report questionnaire with 9 items plus a 10th question. Respondents answered questions regarding how often a symptom has bothered them over the last two weeks. Each item is rated on a 4-point scale (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). PHQ-9 total score is the sum of the nine items, ranging from 0 to 27. Scores of 5, 10, 15, and 20 represent cut-points for mild, moderate, moderately severe and severe depression, respectively. PHQ-9 score at baseline, 6 months, 12 months and at 24 months.

    Measured: baseline, 6 months, 12 months, 24 months

  6. Cardiometabolic risk factors

    Waist circumference will be measured at baseline, 12 months and at 24 months according to standard protocols described by the National Health and Nutrition Examination Surveys (NHANES) Anthropometry Procedures Manual. http://www.cdc.gov/nchs/data/nhanes/nhanes_11_12/Anthropometry_Procedures_Manual.pdf. Published 2011. Accessed October 29, 2014.

    At baseline, 12 months and at 24 months blood pressure will be measured twice by a trained health coach, a third if there is a discrepancy. Blood pressure, fasting glucose, HbA1c, and lipids will be pulled from the medical record for each time point.

    Measured: baseline, 6 months, 12 months, 24 months

  7. Participant Medication Usage

    Participants will be asked to self-report medications/prescriptions. A list of prescribed medications will also be pulled from the electronic health record.

    Measured: baseline, 12 months, 24 months

  8. Dietary Intake Patterns

    Dietary intake will be measured using the gold-standard approach of 3 multiple pass 24-hour recalls (2 during the weekday and 1 on the weekend at each time point). The Nutrition Data System for Research (NDSR), a validated approach, will be used. Changes in dietary intake over 24-months will be assessed.

    Measured: baseline, 6 months, 12 months, 24 months

  9. Food Neophobia Scale

    The Food Neophobia Scale (FNS) is a 10-item questionnaire that is comprised of likert type items ranging from "strongly disagree (1)" to "strongly agree (7)." Participants indicate their level of agreement for statements such as "I will eat almost anything" with higher scores indicating greater agreement per item.

    Measured: baseline, 6 months, 12 months, 24 months

  10. Food Attitudes & Behaviors (FAB) Scale for self-efficacy

    A subset of 7 items regarding Self-Efficacy to Eat Fruits and Vegetables will be used from the validated Food Attitudes \& Behaviors (FAB) scale. These items are answered on a likert scale from "not at all confident" to "very confident" with an option for "does not apply." Scoring details are available on the NIH website (https://cancercontrol.cancer.gov/brp/hbrb/food-attitudes-and-behaviors).

    Measured: baseline, 6 months, 12 months, 24 months

  11. Second Harvest of Silicon Valley Food Bank Self-Efficacy Measure

    Two self-reported items from the Second Harvest of Silicon Valley food bank self-efficacy questionnaire will be asked. They are "In the past few months, have you tried a new recipe using food you received at a free food distribution?" and "And have you tried a new fruit or vegetable that you received at a free food distribution?" Answer choices are yes, no, or I did not receive food.

    Measured: baseline, 6 months, 12 months, 24 months

  12. Participant self-reported 7-day Physical Activity Recall

    The research team will administer the 7-day Physical Activity Recall, a self-report measure of physical activity and sleep.

    Measured: baseline, 6 months, 12 months, 24 months

  13. Participant steps per day

    Steps per day will be verified with data from the Fitbit Alta HR used to calculate steps per day.

    Measured: baseline, 6 months, 12 months, 18 months, 24 months

  14. Number of participants with food insecurity

    The USDA 6-item brief food security measure is a validated tool for assessing household food security. Food security status for each participant at 5 time points over 24 months will be recorded.

    Measured: baseline, 6 months, 12 months, 18 months, 24 months

  15. Self-reported Nutrition Security, Healthfulness Control, and Utilization Barriers Survey Tool

    Each participant self-report answers 4 self-report nutrition security questions, 2 questions about control over the food consumed, and 2 questions about barriers over the last 12 months. Answers choices are a likert scale from Never=0 to Always=4 with higher scores indicating lower levels of nutritional security.

    Sample item: "In the last 12 months, (I/we) had to eat some foods that were not good for (my/our) health and well-being because (I/we) could not get other types of food."

    Measured: baseline, 6 months, 12 months, 18 months, 24 months

  16. Stunkard Figure Rating Scale

    Motivation for weightloss will be measured using the Stunkard Figure Rating Scale. This validated tool uses a diagram showing figures of various shapes and sizes and asks the participant to indicate their current body type and the type they would most like to be. Participants are asked to: (1) choose your ideal figure; (2) choose the figure that reflects how you think you look; (3) choose the figure that reflects how you feel most of the time; (4) choose the figure that you think is most preferred by men; (5) choose the figure that you think is most preferred by women; and (6) pick the opposite sex figure that you find most attractive. Scoring uses discrepancy measures: (1) feel minus ideal; (2) think minus ideal; and (3) feel minus think

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

    Measured: baseline

  17. Level of anxiety among participants

    The validated Generalized Anxiety Scale (GAD-7) will be administered to measure the severity of anxiety that may be present among participants. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 indicate mild, moderate and severe anxiety, respectively.

    Measured: baseline, 6 months, 12 months, 24 months

  18. Bidimensional Acculturation Scale for Hispanics

    This validated self-report 24-item tool will be used to understand how participants communicate in both English and Spanish. Each item is a likert-type with answer choices asking participants to rate the frequency they use a communication practice. Answers range from "Almost always (4)" to "Almost never (1)" or "Very well (4)" to "Very Poorly (1)."

    Measured: baseline

  19. COVID-19 Impact on Health and Wellbeing Survey for Health Literacy

    Four items were selected from the COVID-19 Impact on Health and Wellbeing Survey to capture how participants receive and process health information such as level of comfort with health forms, medical information, and visiting the doctor.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2022
  2. Study start27 Sep 2022
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
412 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05211180
Sponsor's protocol ID
63206
Status last verified
Jul 2025
First submitted
13 Jan 2022
Last updated
14 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be made available to other researchers

Publications

  • Ceccarini M, Borrello M, Pietrabissa G, Manzoni GM, Castelnuovo G. Assessing motivation and readiness to change for weight management and control: an in-depth evaluation of three sets of instruments. Front Psychol. 2015 May 11;6:511. doi: 10.3389/fpsyg.2015.00511. eCollection 2015.

    PubMed 26029126
  • Andres A, Saldana C, Gomez-Benito J. The transtheoretical model in weight management: validation of the processes of change questionnaire. Obes Facts. 2011;4(6):433-42. doi: 10.1159/000335135. Epub 2011 Nov 25.

    PubMed 22248993
  • Gibbs HD, Ellerbeck EF, Gajewski B, Zhang C, Sullivan DK. The Nutrition Literacy Assessment Instrument is a Valid and Reliable Measure of Nutrition Literacy in Adults with Chronic Disease. J Nutr Educ Behav. 2018 Mar;50(3):247-257.e1. doi: 10.1016/j.jneb.2017.10.008. Epub 2017 Dec 12.

    PubMed 29246567
  • 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.

    PubMed 1489209
  • Thompson, J.K., & Altabe, M.N. (1991). Psychometric qualities of the figure rating scale. International Journal of Eating Disorders, 10(5), 615-619.

Questions about this trial

What is this clinical trial studying?

A study testing Vida Sana and Vida Sana y Completa in people with Obesity, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight change (12 months) (time frame: Baseline, 12 months, 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05211180, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.

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