Healthy Eating Education for Latinos

Sponsor
Harvard School of Public Health (HSPH) (Other)
Overall Status
Completed
CT.gov ID
NCT04724382
Collaborator
(none)
76
1
2
28.8
2.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Culturally tailored healthy eating advice
  • Behavioral: Standard healthy eating advice
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Participants will be unaware of the which educational messages are considered intervention or control. Investigators will not be in contact with participants and will only receive coded data. Outcome assessor will be unaware of treatment allocation of participant.
Primary Purpose:
Prevention
Official Title:
Culturally-tailored Healthy Eating Education Intervention for Latinos in Massachusetts
Actual Study Start Date :
Apr 29, 2019
Actual Primary Completion Date :
Sep 22, 2021
Actual Study Completion Date :
Sep 22, 2021

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 reinforcement phase of 2-months will follow to repeat the 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 reinforcement phase of 2-months will follow to repeat the text messages.

Behavioral: Standard healthy eating advice
Standard healthy eating education includes strategies, foods, portions, and cooking and eating tips for general dietary recommendations

Outcome Measures

Primary Outcome Measures

  1. Changes in diet quality score [4 months]

    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 [4 months]

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

  3. Change in levels of blood pressure risk factors [4 months]

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

  4. Changes in diet habits [4 months]

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

Secondary Outcome Measures

  1. Changes in diet satisfaction: diet satisfaction scale [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

Other Outcome Measures

  1. Changes in depression score: CESD [4 months]

    Determine the change in score of depressive symptom screener (range 0-54; from lowest to highest symptoms)

Eligibility Criteria

Criteria

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

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

None specified.

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:
NCT04724382
Other Study ID Numbers:
  • IRB13-1332
First Posted:
Jan 26, 2021
Last Update Posted:
Sep 30, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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 Sep 30, 2021