- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT04710108
Testing Message Modality of Culturally Appropriate Nutrition Communication for Mexican American Women
17 maja 2022 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
129
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
California
-
Merced, California, Stany Zjednoczone, 95343
- University of California Merced SONA System (Online Platform)
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 29 lat (Dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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)
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Brak interwencji: No treatment control
No treatment; no intervention (survey only)
|
|
|
Eksperymentalny: 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)
|
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.
Inne nazwy:
|
|
Eksperymentalny: 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.
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Knowledge
Ramy czasowe: 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.
|
Immediately post-intervention exposure
|
|
Attitude toward sugary beverage consumption
Ramy czasowe: 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
|
Immediately post-intervention exposure
|
|
Subjective norms toward sugary beverage consumption
Ramy czasowe: 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.
|
Immediately post-intervention exposure
|
|
Self-efficacy toward SSB consumption
Ramy czasowe: 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.
|
Immediately post-intervention exposure
|
|
Intention to reduce SSB consumption
Ramy czasowe: 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.
|
Immediately post-intervention exposure
|
|
Media literacy
Ramy czasowe: 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.
|
Immediately post-intervention exposure
|
|
Public health literacy
Ramy czasowe: 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.
|
Immediately post-intervention exposure
|
|
Empowerment
Ramy czasowe: 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.
|
Immediately post-intervention exposure
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Transportation
Ramy czasowe: 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.
|
Immediately post-intervention exposure
|
|
Identification
Ramy czasowe: Immediately post-intervention exposure
|
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.
|
Immediately post-intervention exposure
|
|
Emotional response to video
Ramy czasowe: Immediately post-intervention exposure
|
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.
|
Immediately post-intervention exposure
|
|
Perceived effectiveness
Ramy czasowe: Immediately post-intervention exposure
|
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.
|
Immediately post-intervention exposure
|
|
Willingness to disseminate the message
Ramy czasowe: Immediately post-intervention exposure
|
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.
|
Immediately post-intervention exposure
|
|
Engagement with the message
Ramy czasowe: Immediately post-intervention exposure
|
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.
|
Immediately post-intervention exposure
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Susana Ramirez, University of California, Merced
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
2 grudnia 2020
Zakończenie podstawowe (Rzeczywisty)
15 maja 2021
Ukończenie studiów (Rzeczywisty)
25 grudnia 2021
Daty rejestracji na studia
Pierwszy przesłany
12 stycznia 2021
Pierwszy przesłany, który spełnia kryteria kontroli jakości
12 stycznia 2021
Pierwszy wysłany (Rzeczywisty)
14 stycznia 2021
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
19 maja 2022
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
17 maja 2022
Ostatnia weryfikacja
1 maja 2022
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- K01CA190659-5
- K01CA190659 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Nie
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Odżywianie
-
Duke UniversityZakończonyLeczenie i zapobieganie niedokrwistości po podaniu batonu Gudness NutritionIndie
Badania kliniczne na Health Communication
-
McMaster UniversityHealth CanadaRekrutacyjnyKomunikacja | Opieka paliatywna | Edukacja lekarzy podstawowej opieki zdrowotnejKanada
-
University of Colorado, DenverSan Diego State University; University of Kansas Medical CenterRekrutacyjnyInfekcja HPV | Profilaktyczne usługi zdrowotneStany Zjednoczone
-
Radicle ScienceZakończonyZdrowie przewodu pokarmowegoStany Zjednoczone
-
Ohio State UniversityJeszcze nie rekrutacjaChoroba wieńcowa | Przewlekła zastoinowa niewydolność serca | Zawał mięśnia sercowego (MI) | Leczenie zastoinowej niewydolności sercaStany Zjednoczone
-
Radicle ScienceZakończonyBól brzucha | Trawienie | Zaburzenia przewodu pokarmowegoStany Zjednoczone
-
Manan ShuklaZakończonyAstma | Przewlekła chorobaStany Zjednoczone
-
Noctrix Health, Inc.ZakończonySyndrom niespokojnych nógStany Zjednoczone
-
Emory UniversityJeszcze nie rekrutacjaZakażenia wirusem HIVStany Zjednoczone
-
Changzhou No.2 People's HospitalRekrutacyjny
-
Radicle ScienceZakończonyDepresja | Ból | Spać | LękStany Zjednoczone