Study Summary
This trial is testing different approaches to help Latinas who are obese and food insecure. The hope is that this will provide evidence on the best way to help this population, and also help with implementing and spreading this information.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 27 Secondary · Reporting Duration: baseline, 6 months, 12 months, 18 months, 24 months
6 months, 18 months
Self-reported weight
Month 24
Weight change (12 months)
baseline
Bidimensional Acculturation Scale for Hispanics
COVID-19 Impact on Health and Wellbeing Survey for Health Literacy
Motivation for weightloss
Stunkard Figure Rating Scale
Month 24
EHR weight
Participant Medication Usage
Visit or EHR Height, Weight, and Waist Circumference
Month 24
Diet
Level of food literacy among participants
Medications
Food Insecurity
Nutrition & physical activity knowledge, self-efficacy, and skills
Participant steps per day
Physical activity
Self-reported Nutrition Security, Healthfulness Control, and Utilization Barriers Survey Tool
USDA 18-item food security measure
Month 24
Cardiometabolic risk factors
Depressive Symptoms
Dietary Intake Patterns
Food Attitudes & Behaviors (FAB) Scale for self-efficacy
Food Neophobia Scale
Health-related quality of life
Level of anxiety among participants
Obesity
Participant self-reported 7-day Physical Activity Recall
Second Harvest of Silicon Valley Food Bank Self-Efficacy Measure
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Vida Sana
1 of 2
Vida Sana y Completa
1 of 2
Active Control
Experimental Treatment
412 Total Participants · 2 Treatment Groups
Primary Treatment: Vida Sana y Completa · No Placebo Group · N/A
Vida Sana y Completa
Behavioral
Experimental Group · 1 Intervention: Vida Sana y Completa · Intervention Types: BehavioralVida Sana
Behavioral
ActiveComparator Group · 1 Intervention: Vida Sana · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 6 months, 12 months, 18 months, 24 months
Who is running the clinical trial?
Patient-Centered Outcomes Research InstituteOTHER
497 Previous Clinical Trials
29,838,734 Total Patients Enrolled
17 Trials studying Obesity
3,385,020 Patients Enrolled for Obesity
Stanford UniversityLead Sponsor
2,182 Previous Clinical Trials
35,790,341 Total Patients Enrolled
65 Trials studying Obesity
116,732 Patients Enrolled for Obesity
San Mateo Medical CenterOTHER
3 Previous Clinical Trials
659 Total Patients Enrolled
1 Trials studying Obesity
207 Patients Enrolled for Obesity
Lisa Goldman Rosas, PhD, MPHPrincipal InvestigatorStanford University
2 Previous Clinical Trials
779 Total Patients Enrolled
2 Trials studying Obesity
779 Patients Enrolled for Obesity
Wei-ting Chen, PhDStudy DirectorStanford University
Eligibility Criteria
Age 18+ · Female Participants · 12 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You self-identify as Latinx.
References
- 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.
- 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. Review.
- Andrés A, Saldaña C, Gómez-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.
- Pliner P, Hobden K. Development of a scale to measure the trait of food neophobia in humans. Appetite. 1992 Oct;19(2):105-20.
- Thompson, J.K., & Altabe, M.N. (1991). Psychometric qualities of the figure rating scale. International Journal of Eating Disorders, 10(5), 615-619.
- 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.
- 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.
- 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.
- Lisa Goldman Rosas 2022. "Vida Sana y Completa Obesity and Food Insecurity Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05211180.
Frequently Asked Questions
What is the largest number of participants that this experiment can accommodate?
"Affirmative. Per the information on clinicaltrials.gov, this medical trial is currently searching for appropriate candidates and has been since September 27th 2022. The study aims to recruit 412 patients from one location." - Anonymous Online Contributor
Unverified Answer
Are there any openings available for prospective participants in this research endeavor?
"Indeed, clinicaltrials.gov shows that this research endeavour is still looking for participants. The trial was first published on September 27th 2022 and most recently updated on the same day; a total of 412 patients need to be found at 1 center." - Anonymous Online Contributor
Unverified Answer