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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04724382
Other study ID # IRB13-1332
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 29, 2019
Est. completion date September 22, 2021

Study information

Verified date October 2023
Source Harvard School of Public Health (HSPH)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date September 22, 2021
Est. primary completion date September 22, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


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

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
Other Changes in depression score: CESD Determine the change in score of depressive symptom screener (range 0-54; from lowest to highest symptoms) 4 months
Other Change in levels of adipose risk factor Estimate the change in the value of waist circumference (cm) 4 months
Other Change in levels of blood pressure risk factors Estimate the change in the value of systolic and diastolic blood pressure (mmHg) 4 months
Other Changes in dysfunctional eating behaviors 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
Primary Changes in diet quality score Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality) 4 months
Primary Changes in diet habits Determine the change in the frequency of dietary behaviors (percent) 4 months
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 4 months
Secondary Changes in attitude for eating: attitudes scale 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
Secondary Changes in reasons for eating: reasons scale Determine the change in the score of the reasons scale (range 0-15; fewer to more reasons to eat healthy) 4 months
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