NCT04710108

Brief Summary

A randomized controlled trial to test the effects of culturally appropriate nutrition communication delivered via different modalities for Mexican American women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2021

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

January 12, 2021

Last Update Submit

May 17, 2022

Conditions

Keywords

Values-based messagesMessage modalityHealth communication

Outcome Measures

Primary Outcomes (8)

  • 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.

    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

    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.

    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.

    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.

    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.

    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.

    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.

    Immediately post-intervention exposure

Secondary Outcomes (6)

  • Transportation

    Immediately post-intervention exposure

  • Identification

    Immediately post-intervention exposure

  • Emotional response to video

    Immediately post-intervention exposure

  • Perceived effectiveness

    Immediately post-intervention exposure

  • Willingness to disseminate the message

    Immediately post-intervention exposure

  • +1 more secondary outcomes

Study Arms (3)

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)

Other: Health Communication

Print

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)

Other: Health Communication

Interventions

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.

Also known as: Values based messaging about sugar sweetened beverages
PrintVideo

Eligibility Criteria

Age18 Years - 29 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsSelf-identify as women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Self-identify as Latina or Hispanic
  • Self-identify as a woman
  • Self-reported as being of age between 18-29 years

You may not qualify if:

  • Not Mexican American (defined as having at least 1 grandparent born in Mexico or self-identifying as Mexican or Mexican American)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Merced SONA System (Online Platform)

Merced, California, 95343, United States

Location

MeSH Terms

Conditions

Mental DisordersRisk Reduction Behavior

Interventions

Health Communication

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

  • Susana Ramirez

    University of California, Merced

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 14, 2021

Study Start

December 2, 2020

Primary Completion

May 15, 2021

Study Completion

December 25, 2021

Last Updated

May 19, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations