NCT04352530

Brief Summary

A randomized controlled trial to test the effects of culturally appropriate nutrition communication for Mexican American women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
881

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 25, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2022

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

1.8 years

First QC Date

March 25, 2020

Last Update Submit

May 8, 2023

Conditions

Keywords

sugar sweetened beveragesHealth CommunicationValues-based messagesLatinasLatinxHispanicExperimentMessage testingtailoring

Outcome Measures

Primary Outcomes (1)

  • Perceived effectiveness

    Perceived effectiveness of the message is known to affect intention to engage in a given health behavior. Therefore, perceived effectiveness of the stimuli was assessed as a proxy measure for intention to reduce sugary beverage consumption using a 5-point, 13-item Likert scale with responses ranging from Strongly Agree=5 to Strongly Disagree=1. This scale comprised 3 subscales namely (1) Message Acceptance - 2 items, (2) Argument Strength - 4 items, (3) Personalized Perceived Effectiveness - 7 items. Greater scores on this scale represented greater levels of perceived effectiveness of the message.

    Immediately post-intervention

Secondary Outcomes (9)

  • Identification with the message

    Immediately post-intervention

  • Activation of social justice values

    Immediately post-intervention

  • Sugary beverage related media literacy

    Pre-test and Immediately post-intervention

  • Public health literacy

    Pre-test and Immediately post-intervention

  • Empowerment

    Pre-test and Immediately post-intervention

  • +4 more secondary outcomes

Study Arms (8)

Rewind the Future

ACTIVE COMPARATOR

Fear appeal, video message to reduce sugar consumption or risk death

Other: Health Communication

Hear No

EXPERIMENTAL

Video of spoken word poem from The Bigger Picture project, "Hear No" by Joshua Merchant; images of African-American male poet interspersed with images of environment

Other: Health Communication

The Longest Mile

EXPERIMENTAL

Video of spoken word poem from The Bigger Picture Project, "The Longest Mile" by Tassiana Willis; images of African-American female poet interspersed with images of environment

Other: Health Communication

A Taste of Home

EXPERIMENTAL

Video of spoken word poem from The Bigger Picture Project, "A Taste of Home" by Monica Mendoza; images of Hispanic female poet interspersed with images of environment

Other: Health Communication

Lost in Translation

EXPERIMENTAL

Video of spoken word poem from The Bigger Picture Project, "Lost in Translation" by Yosimar Reyes; images of Hispanic male poet interspersed with images of environment

Other: Health Communication

Bottled Up

EXPERIMENTAL

Video of spoken word poem from The Bigger Picture Project, "Bottled Up" by Eileen Torrez; images of Hispanic female poet interspersed with images of environment

Other: Health Communication

The Corner

EXPERIMENTAL

Video of spoken word poem from The Bigger Picture Project, "The Corner" by Jose Vadi; images of Hispanic male poet interspersed with images of environment

Other: Health Communication

Thin Line

EXPERIMENTAL

Video of spoken word poem from The Bigger Picture Project, "Thin Line" by Ivori Holson; images of African-American female poet interspersed with images of environment

Other: Health Communication

Interventions

Spoken word poems set to images performed by youth who wrote the poems. Videos were produced by The Bigger Project and were posted publicly to the Bigger Picture Project website and YouTube. Duration of videos ranges from 2 minutes to 6 minutes.

A Taste of HomeBottled UpHear NoLost in TranslationRewind the FutureThe CornerThe Longest MileThin Line

Eligibility Criteria

Age18 Years - 29 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself-identify as female
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Self-identify as Latina/x or Hispanic
  • Self-identify as a woman
  • Self-reported as being of age between 18-29 years
  • Undergraduate students enrolled in SONA at UC Merced

You may not qualify if:

  • \- Not Mexican American

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Merced SONA System (Online Platform)

Merced, California, 95343, United States

Location

MeSH Terms

Conditions

Risk Reduction BehaviorMalnutritionChronic DiseaseObesityBreast Neoplasms

Interventions

Health Communication

Condition Hierarchy (Ancestors)

BehaviorNutrition DisordersNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionBody WeightSigns and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 25, 2020

First Posted

April 20, 2020

Study Start

March 25, 2019

Primary Completion

December 25, 2020

Study Completion

December 25, 2022

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations