NCT04724382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2021

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

2.4 years

First QC Date

January 22, 2021

Last Update Submit

October 24, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • Changes in diet habits

    Determine the change in the frequency of dietary behaviors (percent)

    4 months

Secondary Outcomes (3)

  • Changes in diet satisfaction: diet satisfaction scale

    4 months

  • Changes in attitude for eating: attitudes scale

    4 months

  • Changes in reasons for eating: reasons scale

    4 months

Other Outcomes (4)

  • Changes in depression score: CESD

    4 months

  • Change in levels of adipose risk factor

    4 months

  • Change in levels of blood pressure risk factors

    4 months

  • +1 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

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

Intervention

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

Control

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard TH Chan School of Public Health

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Mattei J, Caballero-Gonzalez A, Maafs-Rodriguez A, Zhang A, O'Neill HJ, Gago C. Lessons learned by adapting and implementing LUCHA: a deep-structure culturally tailored healthy eating randomized pilot intervention for ethnic-diverse Latinos. Front Public Health. 2024 Feb 20;11:1269390. doi: 10.3389/fpubh.2023.1269390. eCollection 2023.

MeSH Terms

Conditions

Feeding BehaviorObesity

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Donald and Sue Pritzker Associate Professor of Nutrition

Study Record Dates

First Submitted

January 22, 2021

First Posted

January 26, 2021

Study Start

April 29, 2019

Primary Completion

September 22, 2021

Study Completion

September 22, 2021

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
1 year
Access Criteria
The requested data will be shared with investigators via a secured, password-protected software website, upon request.

Locations