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Completed

NCT Number: NCT05589740

Culturally Optimized Messages for Latinos

This project aims to redesign and optimize a deep-structure culturally-tailored healthy eating program and test its effectiveness in improving dietary outcomes, anthropometric, and blood pressure among 75 diverse Latinos, compared to surface-level messages.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harvard TH Chan School of Public Health

Boston, Massachusetts, 02115, United States

About this study

This project aims to redesign and optimize a deep-structure culturally-tailored healthy eating program and test its effectiveness in improving dietary outcomes, anthropometric, and blood pressure among 75 diverse Latinos, compared to surface-level messages. The WELCOME study will be based on the RE-AIM framework with improved reach, adoption, implementation, and maintenance strategies. The intervention arm is a deep-structure cultural tailored text messages for distinct Latino heritages (e.g., Caribbean and non-Caribbean) informed by mixed-methods formative research, compared to surface-level healthy eating messages based on the USDA My Plate Spanish version. The program runs for 6 months: 2-months delivery phase + 2-months reinforcement phase + 2-months maintenance phase.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 25-65 y/o
  • self-reported Hispanic/Latino heritage
  • able to understand and answer questions in Spanish or English
  • living in Massachusetts for the past year and not planning to move in the next year
  • having a cellphone with the capacity of receiving and sending text messages and giving consent for the Study to text this number as part of the intervention

Exclusion criteria

  • self-reported diagnosis of cancer, diabetes or major stomach or heart condition (e.g.: gastrointestinal cancers, coronary heart disease, previous stroke or heart attack, severe dietary allergies or restrictions)
  • planning to move Massachusetts in the next year
  • currently pregnant
  • institutionalized (i.e.: hospital, prison, etc.).

Treatment and study plan

Culturally tailored healthy eating advice

Behavioral

Culturally-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc.

Standard healthy eating advice

Behavioral

Standard healthy eating education includes strategies, foods, portions, and cooking and eating tips for general dietary recommendations from USDA My Plate

Primary outcomes

  1. Changes in diet quality score

    Time frame: Month 4

    Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)

  2. Change in levels of adipose risk factor

    Time frame: Month 4

    Estimate the change in the value of waist circumference (cm)

  3. Change in levels of blood pressure risk factor

    Time frame: Month 4

    Estimate the change in the value of systolic and diastolic blood pressure (mmHg)

  4. Change in dietary habits

    Time frame: Month 4

    Determine the change in the score of dietary behaviors (range 1-5)

Secondary outcomes

  1. Changes in diet satisfaction: diet satisfaction scale

    Time frame: Month 4

    Determine the change in the score of the Diet Satisfaction Questionnaire (DSat-45) (range 45-225; from lowest to highest satisfaction) and its summed seven subscales (ranges 5-40

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Registry information

Official study title

Wellness With Culturally Optimized Messages for Ethnic-diverse Latinos

Acronym: WELCOME

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 21, 2022
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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