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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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 groups in NCT04352530
Study groupRoleWhat they receive
Rewind the FutureActive comparatorFear appeal, video message to reduce sugar consumption or risk death
Receives: Other: Health Communication
Hear NoExperimentalVideo 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 MileExperimentalVideo 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 HomeExperimentalVideo 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 TranslationExperimentalVideo 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 UpExperimentalVideo 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 CornerExperimentalVideo 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 LineExperimentalVideo 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.

  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.

    Measured: Immediately post-intervention

Secondary outcomes (9)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Engagement

    Engagement with the message was assessed with 2 items from the Narrative Transportation Scale (Green et al.).

    Measured: Immediately post-intervention

  8. 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

  9. 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.

  1. First posted20 Apr 2020
  2. Study start25 Mar 2019
  3. Primary completion25 Dec 2020
  4. Study completion25 Dec 2022

Resources

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)
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

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.

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