Culturally Optimized Messages for Latinos (WELCOME)

Wellness With Culturally Optimized Messages for Ethnic-diverse 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.

Study Overview

• Status: Completed
• Conditions: Obesity; Blood Pressure; Diet, Healthy; Diet Habit; Psychological
• Intervention / Treatment: Behavioral: Culturally tailored healthy eating advice; Behavioral: Standard healthy eating advice

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Harvard TH Chan School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Intervention group consisting of culturally-tailored healthy eating advice through daily text messages for 2 months (delivery phase); a subsequent reinforcement phase of 2-months to repeat the text messages; and a subsequent maintenance phase of 2-months with no text messages.	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.
Active Comparator: Control; Control group consisting of general healthy eating advice through daily text messages for 2 months (delivery phase); a subsequent reinforcement phase of 2-months to repeat the text messages; and a subsequent maintenance phase of 2-months with no text messages.	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in levels of adipose risk factor	Estimate the change in the value of waist circumference (cm)	Month 4
Change in levels of blood pressure risk factor	Estimate the change in the value of systolic and diastolic blood pressure (mmHg)	Month 4
Change in dietary habits	Determine the change in the score of dietary behaviors (range 1-5)	Month 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Investigators: Principal Investigator: Josiemer Mattei, PhD, Harvard Chan School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Actual): April 29, 2024
• Study Completion (Actual): May 2, 2024

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Estimated): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB22-0828

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study personnel will manage and distribute the data generated from the study with other investigators observing NIH policy on the dissemination and sharing of research results. Study information and requests for data will be available immediately upon the data being coded and properly revised for quality control after culmination of the study; deidentified data will be available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No