- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04352530
Culturally Appropriate Nutrition Communication for Mexican American Women
May 8, 2023 updated by: A. Susana Ramirez, University of California, Merced
Culturally Appropriate Nutrition Communication for Mexican American Women: A Randomized Controlled Trial
A randomized controlled trial to test the effects of culturally appropriate nutrition communication for Mexican American women.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
An unbalanced randomized controlled trial with pre-test and immediate post-test was employed to test the effects of different types of message features and appeals.
The study was conducted online with Mexican American women aged 18-29 years old.
Messages focused on sugary beverage consumption and the main outcomes were acceptance and receptivity to the message (i.e., perceived effectiveness), perceptions of social norms, and knowledge.
The investigators also measured a number of hypothesized mediators and moderators of the effects.
Study Type
Interventional
Enrollment (Actual)
881
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Merced, California, United States, 95343
- University of California Merced SONA System (Online Platform)
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years to 29 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Not Mexican American
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Rewind the Future
Fear appeal, video message to reduce sugar consumption or risk death
|
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.
|
|
Experimental: Hear No
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
|
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.
|
|
Experimental: The Longest Mile
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
|
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.
|
|
Experimental: A Taste of Home
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
|
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.
|
|
Experimental: Lost in Translation
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
|
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.
|
|
Experimental: Bottled Up
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
|
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.
|
|
Experimental: The Corner
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
|
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.
|
|
Experimental: Thin Line
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived effectiveness
Time Frame: Immediately post-intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification with the message
Time Frame: Immediately post-intervention
|
responses ranging from Strongly Agree=5 to Strongly Disagree=1.
Two sample items from the scale are, "During viewing, I felt I could really get inside the person's head", and "At key moments in the video, I felt I knew exactly what they were going through".
Greater scores on this scale represent greater degree of identification with the character in the video.
|
Immediately post-intervention
|
|
Activation of social justice values
Time Frame: Immediately post-intervention
|
Activation of social justice values was measured using a 5-point, 2-item Likert scale with responses ranging from Strongly Agree=5 to Strongly Disagree=1.
The two items are, "The message made me think that when I choose to eat healthy, I'm helping to make the world a better place" and "The message made me think that when I eat healthy, I'm doing my part to protect people who are being manipulated by sugary beverage companies".
Greater scores on this scale represent greater levels of activation of social justice values.
|
Immediately post-intervention
|
|
Sugary beverage related media literacy
Time Frame: Pre-test and Immediately post-intervention
|
Sugary beverage related media literacy was measured using a 5-point, 8-item Likert scale with responses ranging from Strongly Agree=5 to Strongly Disagree=1.
This scale measured how much the participants understood the ways in which sugary beverage industry used media to influence and manipulate their sugary beverage consumption behaviors.
Some sample items are as follows: "Certain sugary drink brands are designed to appeal to people like me", "Sugary drink ads show a healthy lifestyle to make people forget about the health risks, such as weight gain and diabetes" and "Sugary drink ads link drinking these beverages to things people want, like love, good looks, and power".
Greater scores on this scale represent greater levels of sugary beverage media literacy.
|
Pre-test and Immediately post-intervention
|
|
Public health literacy
Time Frame: Pre-test and Immediately post-intervention
|
Public health literacy is defined here as an understanding of the social determinants of health.
This was measured using a 5-point and 7-item Likert scale with responses ranging from Strongly Agree=5 to Strongly Disagree=1.
The seven items measured opinions about how much different external factors affect health because these best reflected an understanding of the social determinants of health: (1) money, (2) education, (3) safe and affordable housing, (4) early childhood experiences, and (5) government policies and programs (6) lifestyle choices and (7) consequences of system failure on the under-resourced.
Greater scores on this scale represented greater levels of public health literacy.
|
Pre-test and Immediately post-intervention
|
|
Empowerment
Time Frame: Pre-test and Immediately post-intervention
|
Empowerment to engage in civic action was measured using a two-item index that assessed the perceived effectiveness of engaging in civic actions.
Each question was a 4-point Likert item with responses ranging from "Very Effective=4" to "Very Ineffective=1".
The two items were as follows, "How effective would it be to boycott sugary beverages as a way to convince corporations to stop pushing sugar to my community?"
and "How effective would it be to use social media to convince corporations to stop pushing sugar to vulnerable groups?".
Greater scores on this index represented greater levels of efficacy to engage in civic action.
|
Pre-test and Immediately post-intervention
|
|
Beverage knowledge
Time Frame: Pre-test and Immediately post-intervention
|
Knowledge increases self-efficacy and empowers people to make better health choices for themselves and knowledge of the negative consequences of a given health behavior increases the intention to reduce that behavior.
Therefore, better knowledge of the negative consequences of sugary beverage consumption directly impacts both individual level sugary beverage consumption as well as social level psychological empowerment to advocate for reduction in sugary beverage consumption at the community level.
A sugary beverage knowledge scale comprised 6 true or false items adapted from multiple studies.
The statements were as follows: Excessive sugar consumption causes, (1) health problems (2) weight gain (3) dental caries (4) diabetes (5) cancer and (6) heart disease".
Greater scores on this scale represented greater levels of sugary beverage knowledge.
|
Pre-test and Immediately post-intervention
|
|
Engagement
Time Frame: Immediately post-intervention
|
Engagement with the message was assessed with 2 items from the Narrative Transportation Scale (Green et al.).
|
Immediately post-intervention
|
|
Similarity
Time Frame: Immediately post-intervention
|
Perceived similarity of the participant with the main character (poet/speaker) in the video was assessed with a 2-item scale adapted from Cohen and colleagues (2018).
|
Immediately post-intervention
|
|
Elaboration
Time Frame: Immediately post-intervention
|
Elaboration of the message arguments was assessed using a 4-point scale created by Kahlor and colleagues (2003) and a 3-point sugar-specific elaboration scale created by Dixon and colleagues (2015).
|
Immediately post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 Major Dates
Study Start (Actual)
March 25, 2019
Primary Completion (Actual)
December 25, 2020
Study Completion (Actual)
December 25, 2022
Study Registration Dates
First Submitted
March 25, 2020
First Submitted That Met QC Criteria
April 16, 2020
First Posted (Actual)
April 20, 2020
Study Record Updates
Last Update Posted (Actual)
May 9, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K01CA190659 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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