WELCOME: Culturally Optimized Messages for Latinos

• Sponsor: Harvard School of Public Health (HSPH) (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05589740
• Collaborator: (none)
• Enrollment: 76
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17.6
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diet, Healthy; Diet Habit; Obesity; Blood Pressure; Psychological	Behavioral: Culturally tailored healthy eating advice; Behavioral: Standard healthy eating advice	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Wellness With Culturally Optimized Messages for Ethnic-diverse Latinos
• Actual Study Start Date: Jul 13, 2022
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Changes in diet quality score [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 [Month 4]

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

3. Change in levels of blood pressure risk factor [Month 4]

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

4. Change in dietary habits [Month 4]

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

Secondary Outcome Measures

1. Changes in diet satisfaction: diet satisfaction scale [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harvard TH Chan School of Public Health	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Harvard School of Public Health (HSPH)

Investigators

• Principal Investigator: Josiemer Mattei, PhD, Harvard Chan School of Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Josiemer Mattei, Donald and Sue Pritzker Associate Professor of Nutrition, Harvard School of Public Health (HSPH)
• ClinicalTrials.gov Identifier: NCT05589740
• Other Study ID Numbers: IRB22-0828
• First Posted: Oct 21, 2022
• Last Update Posted: Oct 21, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 21, 2022