Culturally Optimized Messages for Latinos

Obesity Clinical Trial

— WELCOME  

Official title:

Wellness With Culturally Optimized Messages for Ethnic-diverse Latinos

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05589740
• Other study ID #: IRB22-0828
• Status: Completed
• Phase: N/A
• Start date: July 13, 2022
• Est. completion date: May 2, 2024

Study information

• Verified date: May 2024
• Source: Harvard School of Public Health (HSPH)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 2, 2024
• Est. primary completion date: April 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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:

1. 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)

2. planning to move Massachusetts in the next year

3. currently pregnant

4. institutionalized (i.e.: hospital, prison, etc.).

Related Conditions & MeSH terms

• Blood Pressure
• Diet Habit
• Diet, Healthy
• Obesity
• Psychological

Intervention

Behavioral:
• Culturally tailored healthy eating advice
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
Standard healthy eating education includes strategies, foods, portions, and cooking and eating tips for general dietary recommendations from USDA My Plate

Locations

Country	Name	City	State
United States	Harvard TH Chan School of Public Health	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Harvard School of Public Health (HSPH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in diet quality score	Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)	Month 4
Primary	Change in levels of adipose risk factor	Estimate the change in the value of waist circumference (cm)	Month 4
Primary	Change in levels of blood pressure risk factor	Estimate the change in the value of systolic and diastolic blood pressure (mmHg)	Month 4
Primary	Change in dietary habits	Determine the change in the score of dietary behaviors (range 1-5)	Month 4
Secondary	Changes in diet satisfaction: diet satisfaction scale	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	Month 4