Culturally Optimized Messages for Latinos

NCT ID: NCT05589740

Last Updated: 2024-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-13

Study Completion Date

2024-05-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diet, Healthy Diet Habit Obesity Blood Pressure Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Culturally tailored healthy eating advice

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Standard healthy eating advice

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.).
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Harvard School of Public Health (HSPH)

OTHER

Sponsor Role lead

Responsible Party

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Josiemer Mattei

Donald and Sue Pritzker Associate Professor of Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Josiemer Mattei, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard Chan School of Public Health

Locations

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Harvard TH Chan School of Public Health

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB22-0828

Identifier Type: -

Identifier Source: org_study_id

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