Lifestyle Risk ReductionNCT04352530
Culturally Appropriate Nutrition Communication for Mexican American Women
A study testing Health Communication in people with Lifestyle Risk Reduction and Nutrition Poor, 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 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
- Lifestyle Risk Reduction, Nutrition Poor, Chronic Disease
- What is being tested?
- Health Communication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 881 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2019to 25 Dec 2022
- 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/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
Who cannot join
- Not 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
Official title: 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.
Read the 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.
- Being tested
- Health Communication
- Keywords
- sugar sweetened beverages, Health Communication, Values-based messages, Latinas, Latinx, Hispanic, Experiment, Message testing, tailoring
- Medical subject headings
- Risk Reduction Behavior, Malnutrition, Chronic Disease, Obesity, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CommunicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Rewind the Future | Active comparator | Fear appeal, video message to reduce sugar consumption or risk death Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Health Communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately post-intervention
Secondary outcomes (9)
Identification with the message
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.
Measured: Immediately post-intervention
Activation of social justice values
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.
Measured: Immediately post-intervention
Sugary beverage related media literacy
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.
Measured: Pre-test and Immediately post-intervention
Public health literacy
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.
Measured: Pre-test and Immediately post-intervention
Empowerment
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.
Measured: Pre-test and Immediately post-intervention
Beverage knowledge
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.
Measured: Pre-test and Immediately post-intervention
Engagement
Engagement with the message was assessed with 2 items from the Narrative Transportation Scale (Green et al.).
Measured: Immediately post-intervention
Similarity
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).
Measured: Immediately post-intervention
Elaboration
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).
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start25 Mar 2019
- Primary completion25 Dec 2020
- Study completion25 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lifestyle Risk ReductionStudies 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
- Masking
- None (open label)
- Enrolment
- 881 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352530
- Sponsor's protocol ID
- K01CA190659
- Other IDs
- K01CA190659
- Status last verified
- May 2023
- First submitted
- 25 Mar 2020
- Last updated
- 9 May 2023
- 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 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Appropriate Nutrition Communication for Mexican American Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04352530
- Acronym / sponsor ID
- K01CA190659
- Keywords
- sugar sweetened beverages, Health Communication, Values-based messages, Latinas, Latinx, Hispanic, Experiment, Message testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 881 participants (actual)
- Lead sponsor
- University of California, MercedUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 25 Dec 2020 (actual)
- Study completion
- 25 Dec 2022 (actual)
- First posted
- 20 Apr 2020 (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 for Mexican American women.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Rewind the Future | Active comparator | Other: Health CommunicationFear appeal, video message to reduce sugar consumption or risk death |
| Hear No | Experimental | Other: Health CommunicationVideo 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 |
| The Longest Mile | Experimental | Other: Health CommunicationVideo 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 |
| A Taste of Home | Experimental | Other: Health CommunicationVideo 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 |
| Lost in Translation | Experimental | Other: Health CommunicationVideo 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 |
| Bottled Up | Experimental | Other: Health CommunicationVideo of spoken word poem from The Bigger Picture Project, "Bottled Up" by Eileen Torrez; images of Hispanic female poet interspersed with images of environment |
| The Corner | Experimental | Other: Health CommunicationVideo of spoken word poem from The Bigger Picture Project, "The Corner" by Jose Vadi; images of Hispanic male poet interspersed with images of environment |
| Thin Line | Experimental | Other: Health CommunicationVideo 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 |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Not 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 CommunicationSpoken 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. | Other | A Taste of Home, Bottled Up, Hear No, Lost in Translation, Rewind the Future, The Corner, The Longest Mile, Thin Line |
Primary outcome
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.
9 secondary outcomes
Identification with the message
Time frame: Immediately post-intervention
Activation of social justice values
Time frame: Immediately post-intervention
Sugary beverage related media literacy
Time frame: Pre-test and Immediately post-intervention
Public health literacy
Time frame: Pre-test and Immediately post-intervention
Empowerment
Time frame: Pre-test and Immediately post-intervention
Beverage knowledge
Time frame: Pre-test and Immediately post-intervention
Engagement
Time frame: Immediately post-intervention
Similarity
Time frame: Immediately post-intervention
Elaboration
Time frame: Immediately post-intervention
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 9 May 2023.
- Individual participant dataSharing planned: No
Related trials for Lifestyle Risk Reduction
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Culinary And Lifestyle Medicine Education for Cancer Risk Reduction in Survivors of Breast Cancer
Breast Cancer
Active, not recruitingPhase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
Risk Reduction, Breast Cancer
Recruiting
SMART GOALS for Youth With Prediabetes
PreDiabetes, Adolescent Obesity
RecruitingObservational study
Breast Cancer Risk Assessment in Night Shift Workers - Implementation of a Personalized Consultation
Breast Neoplasms Diagnosis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lifestyle Risk Reduction and Nutrition Poor, 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 4 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 9 May 2023. 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?
Perceived effectiveness (time frame: Immediately post-intervention). 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 9 May 2023.