Sugar Sweetened Beverage ConsumptionNCT04710108
Testing Message Modality of Culturally Appropriate Nutrition Communication for Mexican American Women
A study testing Health Communication in people with Sugar Sweetened Beverage Consumption and Nutrition, run by University of California, Merced at 1 site in United States.
Trial summary
A randomized controlled trial to test the effects of culturally appropriate nutrition communication delivered via different modalities for Mexican American women. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Sugar Sweetened Beverage Consumption, Nutrition, Lifestyle-related Condition
- What is being tested?
- Health Communication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2020to 25 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-identify as Latina or Hispanic
- Self-identify as a woman
- Self-reported as being of age between 18-29 years
Who cannot join
- Not Mexican American (defined as having at least 1 grandparent born in Mexico or self-identifying as Mexican or Mexican American)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Merced SONA System (Online Platform)
Merced, California, 95343
About this study
A randomized controlled trial to test the effects of culturally appropriate nutrition communication delivered via different modalities for Mexican American women.
Read the 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.
- Conditions
- Sugar Sweetened Beverage Consumption, Nutrition, Lifestyle-related Condition, Lifestyle Risk Reduction
- Being tested
- Health Communication
- Keywords
- Values-based messages, Message modality, Health communication
- Medical subject headings
- Mental Disorders, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CommunicationOther
Also called Values based messaging about sugar sweetened beverages
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.
| Study group | Role | What they receive |
|---|---|---|
| No treatment control | No intervention | No treatment; no intervention (survey only) |
| Video | Experimental | 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) Receives: Other: Health Communication |
| Experimental | 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) Receives: Other: Health Communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge
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.
Measured: Immediately post-intervention exposure
Attitude toward sugary beverage consumption
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
Measured: Immediately post-intervention exposure
Subjective norms toward sugary beverage consumption
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.
Measured: Immediately post-intervention exposure
Self-efficacy toward SSB consumption
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.
Measured: Immediately post-intervention exposure
Intention to reduce SSB consumption
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.
Measured: Immediately post-intervention exposure
Media literacy
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.
Measured: Immediately post-intervention exposure
Public health literacy
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.
Measured: Immediately post-intervention exposure
Empowerment
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.
Measured: Immediately post-intervention exposure
Secondary outcomes (6)
Transportation
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.
Measured: Immediately post-intervention exposure
Identification
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.
Measured: Immediately post-intervention exposure
Emotional response to video
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.
Measured: Immediately post-intervention exposure
Perceived effectiveness
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.
Measured: Immediately post-intervention exposure
Willingness to disseminate the message
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.
Measured: Immediately post-intervention exposure
Engagement with the message
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.
Measured: Immediately post-intervention exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start2 Dec 2020
- Primary completion15 May 2021
- Study completion25 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sugar Sweetened Beverage ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Merced
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, A. Susana Ramirez, University of California, Merced
- Investigators
- Susana Ramirez, Principal investigator, University of California, Merced
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710108
- Sponsor's protocol ID
- K01CA190659-5
- Other IDs
- K01CA190659
- Status last verified
- May 2022
- First submitted
- 12 Jan 2021
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Message Modality of Culturally Appropriate Nutrition Communication for Mexican American Women
- ClinicalTrials.gov ID
- NCT04710108
- Acronym / sponsor ID
- K01CA190659-5
- Conditions
- Sugar Sweetened Beverage Consumption, Nutrition, Lifestyle-related Condition, Lifestyle Risk Reduction
- Keywords
- Values-based messages, Message modality, Health communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of California, MercedUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 25 Dec 2021 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized controlled trial to test the effects of culturally appropriate nutrition communication delivered via different modalities for Mexican American women.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| No treatment control | No intervention | –No treatment; no intervention (survey only) |
| Video | Experimental | Other: Health CommunicationA Taste of Home video, Poet: Monica Mendoza (spoken word poem from The Bigger Picture; images of Hispanic female poet interspersed with images of environment) |
| Experimental | Other: Health CommunicationA 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) |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Self-identify as Latina or Hispanic
- Self-identify as a woman
- Self-reported as being of age between 18-29 years
Key exclusion criteria (1 listed)
- Not Mexican American (defined as having at least 1 grandparent born in Mexico or self-identifying as Mexican or Mexican American)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health CommunicationAlso: Values based messaging about sugar sweetened beveragesSpoken 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 | Print, Video |
Primary outcome
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.
Attitude toward sugary beverage consumption
Time frame: Immediately post-intervention exposure
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
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.
Self-efficacy toward SSB consumption
Time frame: Immediately post-intervention exposure
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.
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.
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.
Public health literacy
Time frame: Immediately post-intervention exposure
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.
Empowerment
Time frame: Immediately post-intervention exposure
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.
6 secondary outcomes
Transportation
Time frame: Immediately post-intervention exposure
Identification
Time frame: Immediately post-intervention exposure
Emotional response to video
Time frame: Immediately post-intervention exposure
Perceived effectiveness
Time frame: Immediately post-intervention exposure
Willingness to disseminate the message
Time frame: Immediately post-intervention exposure
Engagement with the message
Time frame: Immediately post-intervention exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susana Ramirez principal investigator
University of California, Merced
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Communication in people with Sugar Sweetened Beverage Consumption and Nutrition, run by University of California, Merced 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 19 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Knowledge (time frame: Immediately post-intervention exposure). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2022.