- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04710108
Testing Message Modality of Culturally Appropriate Nutrition Communication for Mexican American Women
May 17, 2022 updated by: A. Susana Ramirez, University of California, Merced
A randomized controlled trial to test the effects of culturally appropriate nutrition communication delivered via different modalities for Mexican American women.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A randomized controlled trial with pre-test and immediate post-test was employed to test the effects of different types of message modalities (video vs. comic book).
The study was conducted online with Mexican American women aged 18-29 years old.
Messages focused on sugary beverage consumption and the main outcomes are individual intention to adopt health behaviors which will be measured by the increased degree of individual knowledge, attitudes, subjective norms, self-efficacy, and intention to reduce SSB consumption, as well as social level behavior changes that will be measured by the improved magnitude of public health literacy, SSB media literacy, and empowerment.
Secondary outcomes of interest include the evaluations on the dimension of message themselves include participants' direct reaction to messages and their perceived effectiveness of messages, which will be measured by transportation of messages, identification of characters, emotional response of scenes, perceived effectiveness of messages, engagement with messages, and willingness to disseminate messages.
Study Type
Interventional
Enrollment (Actual)
129
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
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California
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Merced, California, United States, 95343
- University of California Merced SONA System (Online Platform)
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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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Self-identify as Latina or Hispanic
- Self-identify as a woman
- Self-reported as being of age between 18-29 years
Exclusion Criteria:
- Not Mexican American (defined as having at least 1 grandparent born in Mexico or self-identifying as Mexican or 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 |
|---|---|
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No Intervention: No treatment control
No treatment; no intervention (survey only)
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Experimental: Video
A Taste of Home video, Poet: Monica Mendoza (spoken word poem from The Bigger Picture; images of Hispanic female poet interspersed with images of environment)
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Spoken word poem set to video images performed by author.
Comic book was transformed from the video that was equivalent in content to the video.
Other Names:
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Experimental: Print
A Taste of Home comic book, Poet: Monica Mendoza (spoken word poem from The Bigger Picture; images of Hispanic female poet interspersed with images of environment)
|
Spoken word poem set to video images performed by author.
Comic book was transformed from the video that was equivalent in content to the video.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge
Time Frame: Immediately post-intervention exposure
|
Knowledge increases self-efficacy and makes 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 SSB consumption directly impacts individual level SSB consumption.
We created an SSB knowledge scale comprising 6 true or false items adapted from multiple studies.
The statements are 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 SSB knowledge.
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Immediately post-intervention exposure
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Attitude toward sugary beverage consumption
Time Frame: Immediately post-intervention exposure
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The theory of planned behavior (TPB) states that attitude toward reducing SSB consumption is an individual level outcome predicting intention to reduce SSB consumption.
We will measure attitude toward reducing SSB consumption as a single, 5-point Likert item with responses ranging from Very Good=5 to Very Bad=1 as follows: "Reducing my consumption of sugary beverages over the next 3 months would be."
Greater scores on this scale represented more positive attitude toward reducing SSB consumption
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Immediately post-intervention exposure
|
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Subjective norms toward sugary beverage consumption
Time Frame: Immediately post-intervention exposure
|
The TPB states that subjective norms to reduce SSB consumption is an individual level outcome facilitating intention to reduce SSB consumption.
We will measure intention to reduce SSB consumption as a single, 5-point Likert item with responses ranging from Strongly Agree=5 to Strongly Disagree=1 as follows: "Most people who are important to me would approve of my drinking less than 1 cup of sugary drinks each day for the next 3 months."
Greater scores on this scale represented greater levels of intention to reduce SSB consumption.
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Immediately post-intervention exposure
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Self-efficacy toward SSB consumption
Time Frame: Immediately post-intervention exposure
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The TPB states that self-efficacy to reduce SSB consumption is an individual level outcome predicting intention to reduce SSB consumption.
We will measure self-efficacy to reduce SSB consumption as a single, 5-point Likert item with responses ranging from Strongly Agree=5 to Strongly Disagree=1 as follows: "If I really wanted to, I am confident that I could reduce my consumption of sugary beverages over the next 3 months."
Greater scores on this scale represented greater levels of self-efficacy to reduce SSB consumption.
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Immediately post-intervention exposure
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Intention to reduce SSB consumption
Time Frame: Immediately post-intervention exposure
|
The TPB states that intention to reduce SSB consumption is an individual level outcome predicting actual reduction of SSB consumption.
We will measure intention to reduce SSB consumption as a single, 5-point Likert item with responses ranging from Strongly Agree=5 to Strongly Disagree=1 as follows: "I plan to reduce my consumption of sugary beverages over the next 3 months."
Greater scores on this scale represented greater levels of intention to reduce SSB consumption.
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Immediately post-intervention exposure
|
|
Media literacy
Time Frame: Immediately post-intervention exposure
|
We will measure SSB related media literacy using a 5-point, 8-item Likert scale with responses ranging from Strongly Agree=5 to Strongly Disagree=1 adapted from Chen et.
al.(Cronbach's Alpha = 0.83).
This scale measures how much the participants understand the ways in which SSB industry used media to influence and manipulate their SSB 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 SSB media literacy.
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Immediately post-intervention exposure
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Public health literacy
Time Frame: Immediately post-intervention exposure
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Public health literacy is defined here as an understanding of the social determinants of health.
We will measure it using a 5-point and 7-item Likert scale with responses ranging from Strongly Agree=5 to Strongly Disagree=1 (Cronbach's Alpha = 0.78).
The seven items measure opinions about how much different external factors affect health because this 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.
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Immediately post-intervention exposure
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Empowerment
Time Frame: Immediately post-intervention exposure
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Empowerment is defined as a social level construct measured using a 4-point and 8 item Likert scale adapted from Zimmerman et.
al. with responses ranging from Strongly Agree/Very Effective=4 to Strongly Disagree/Not Effective at all=1.
The scale comprised three subscales namely (1) Community control (2 items; Cronbach's Alpha = 0.68); (2) Perceived effectiveness of actions to influence community decisions (3 items; Cronbach's Alpha = 0.79); and (3) Perceived difficulty (3 items, Cronbach's Alpha = 0.78).
Sample questions from each subscale were as follows: "I can influence decisions that affect my community," "How effective would it be to attend meetings about some community issue or problem in convincing public officials and institutions to do something?"
and "Community problems are often so complicated that even informed people can't figure out what should be done about them."
Greater scores on this scale represented greater levels of psychological empowerment.
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Immediately post-intervention exposure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Transportation
Time Frame: Immediately post-intervention exposure
|
We will measure transportation of messages using a 5-point, 2-item Likert scale with responses ranging from Strongly Agree=5 to Strongly Disagree=1 adapted based on scales by Green & Brock and Kim (Cronbach's Alpha = 0.85).
The two items in the scale are, "I could picture myself in the scene of the events shown in the message," and "My attention was fully captured while viewing the message."
Greater scores on this scale represent greater levels of engagement with the video.
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Immediately post-intervention exposure
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Identification
Time Frame: Immediately post-intervention exposure
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Identification is measured using a 5-point, 4-item Likert scale adapted from scales by Cohen and Phua (Cronbach's Alpha = 0.84).
Greater scores on this scale represent greater degree of identification with the character in the video.
Identification with characters also include the perceived similarity with main character in the video, which will be measured using a 5-point, 2-item Likert scale with responses ranging from Strongly Agree=5 to Strongly Disagree=1 adapted from Cohen et.
al. (Cronbach's Alpha = 0.93).
The two items in the scale are, "I feel the person in the message, and I have many things in common," and "The person in the video and I are similar in many ways."
Greater scores represent greater levels of perceived similarity.
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Immediately post-intervention exposure
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Emotional response to video
Time Frame: Immediately post-intervention exposure
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We will measure emotional responses to the video using a 11-item, 5-point scale with responses ranging from Not at all=1 to Extremely=5 adapted from Dixon et.
al. (Cronbach's Alpha = 0.95).
The question stated "We are interested in how this message made you feel.
Please indicate the extent to which the message made you feel…" The scale consisted of seven negative emotions viz., Disgusted, Anxious, Ashamed, Fearful, Guilty, Sad and Angry and four positive emotions viz., Proud, Validated, Hopeful and Empathetic.
Higher scores on this scale represented more positive emotional response to the video.
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Immediately post-intervention exposure
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Perceived effectiveness
Time Frame: Immediately post-intervention exposure
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Perceived effectiveness of the message is known to affect intention to engage in a given health behavior.
Furthermore, some researchers have raised concerns of reactance as a negative consequence of persuasive messages69, 70 while others seem to argue that it does not necessarily affect the efficacy of a message.
Therefore, we will measure perceived effectiveness of and reactance to the stimuli as a proxy measure for intention to reduce SSB consumption using a 5-point, 14-item Likert scale with responses ranging from Strongly Agree=5 to Strongly Disagree=1 adapted from Dixon et.
al and other prior research.
This scale comprised 4 subscales namely (1) Message Acceptance (2 items, Cronbach's Alpha = 0.89); (2) Argument Strength (4 items, Cronbach's Alpha = 0.88); (3) Personalized Perceived Effectiveness (7 items, Cronbach's Alpha = 0.91); and (4) Reactance (1 item).
Greater scores on this scale represented greater levels of perceived effectiveness of the message.
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Immediately post-intervention exposure
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Willingness to disseminate the message
Time Frame: Immediately post-intervention exposure
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We will measure the willingness to disseminate the message by a 10-point Net Promoter Score (NPS) adapted from Alismail et.
al (Cronbach's Alpha = 0.87).
The item is, "On a scale from 0-10, how likely are you to recommend this message to a friend or family".
Greater scores on this scale indicate greater willingness to recommend the message to others.
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Immediately post-intervention exposure
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Engagement with the message
Time Frame: Immediately post-intervention exposure
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Engagement with message in this study means engagement with The Bigger Picture Project campaign since the two experimental treatments were all from this campaign.
We will measure this outcome by clicking the campaign link for more information in Qualtrics shown on the stimuli display pages with clicked = 1 and did not click = 0.
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Immediately post-intervention exposure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Susana Ramirez, University of California, Merced
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)
December 2, 2020
Primary Completion (Actual)
May 15, 2021
Study Completion (Actual)
December 25, 2021
Study Registration Dates
First Submitted
January 12, 2021
First Submitted That Met QC Criteria
January 12, 2021
First Posted (Actual)
January 14, 2021
Study Record Updates
Last Update Posted (Actual)
May 19, 2022
Last Update Submitted That Met QC Criteria
May 17, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- K01CA190659-5
- 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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