- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04724382
Healthy Eating Education for Latinos
October 24, 2023 updated by: Josiemer Mattei, Harvard School of Public Health (HSPH)
Culturally-tailored Healthy Eating Education Intervention for Latinos in Massachusetts
This intervention aims to evaluate the efficacy of a pilot educational intervention with deep-structure cultural tailoring for Latino ethnic groups on diet quality compared to general, surface-level healthy-eating messages.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Harvard TH Chan School of Public Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Aged 25-65 y/o
- Self-reported Hispanic/Latino heritage
- Able to understand and answer questions in Spanish or English
- Living in the Boston, MA metro area for the past 6 months and not planning to move in the next 6 months
- Has a cellphone with the capacity of receiving text messages and gives consent for the Study to text this number as part of the intervention
Exclusion Criteria:
- Younger than 25y or older than 65y
- Not Hispanic/Latino heritage
- Has condition or impairment that affects mental, cognitive, or memory abilities; such as Alzheimer's disease or stroke
- Has been diagnosed with cancer, diabetes (type 1 or 2), heart condition, major stomach condition (examples: coronary heart disease, heart attack, stroke or stroke, allergies, or severe diet restrictions)
- Does not understand Spanish or English
- Pregnant
- Under the care of an institution
- Living in another state outside of Massachusetts or planning to move in less than 6 months
- No cellphone with text capabilities (or cannot be used to receive texts from the Study)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
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 reinforcement phase of 2-months will follow to repeat the text messages.
|
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 reinforcement phase of 2-months will follow to repeat the text messages.
|
Standard healthy eating education includes strategies, foods, portions, and cooking and eating tips for general dietary recommendations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in diet quality score
Time Frame: 4 months
|
Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)
|
4 months
|
|
Changes in diet habits
Time Frame: 4 months
|
Determine the change in the frequency of dietary behaviors (percent)
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in diet satisfaction: diet satisfaction scale
Time Frame: 4 months
|
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
|
4 months
|
|
Changes in attitude for eating: attitudes scale
Time Frame: 4 months
|
Determine the change in the score of the attitudes scale (range 0-20; with positive and negative subscales for more attitudes towards healthy eating)
|
4 months
|
|
Changes in reasons for eating: reasons scale
Time Frame: 4 months
|
Determine the change in the score of the reasons scale (range 0-15; fewer to more reasons to eat healthy)
|
4 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in levels of adipose risk factor
Time Frame: 4 months
|
Estimate the change in the value of waist circumference (cm)
|
4 months
|
|
Change in levels of blood pressure risk factors
Time Frame: 4 months
|
Estimate the change in the value of systolic and diastolic blood pressure (mmHg)
|
4 months
|
|
Changes in depression score: CESD
Time Frame: 4 months
|
Determine the change in score of depressive symptom screener (range 0-54; from lowest to highest symptoms)
|
4 months
|
|
Changes in dysfunctional eating behaviors
Time Frame: 4 months
|
Determine the change in score of the Three-Factor Eating Questionnaire (range 0-4; from lowest to highest dysfunctional eating and the three subscales of emotional, uncontrolled and restrictive eating behaviors)
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 29, 2019
Primary Completion (Actual)
September 22, 2021
Study Completion (Actual)
September 22, 2021
Study Registration Dates
First Submitted
January 22, 2021
First Submitted That Met QC Criteria
January 22, 2021
First Posted (Actual)
January 26, 2021
Study Record Updates
Last Update Posted (Actual)
October 26, 2023
Last Update Submitted That Met QC Criteria
October 24, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- IRB13-1332
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
IPD will be managed and distributed observing NIH and IRB policies on the dissemination and sharing of research results.
Study information and requests for data will be available immediately upon the data being de-identified and properly revised for quality control by contacting study investigators.
IPD Sharing Time Frame
1 year
IPD Sharing Access Criteria
The requested data will be shared with investigators via a secured, password-protected software website, upon request.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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