NCT05589740

Brief Summary

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.

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 Jul 2022

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

July 13, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2024

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

1.8 years

First QC Date

October 14, 2022

Last Update Submit

May 2, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Changes in diet quality score

    Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)

    Month 4

  • Change in levels of adipose risk factor

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

    Month 4

  • Change in levels of blood pressure risk factor

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

    Month 4

  • Change in dietary habits

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

    Month 4

Secondary Outcomes (1)

  • Changes in diet satisfaction: diet satisfaction scale

    Month 4

Study Arms (2)

Intervention

EXPERIMENTAL

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.

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 subsequent reinforcement phase of 2-months to repeat the text messages; and a subsequent maintenance phase of 2-months with no 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 from USDA My Plate

Control

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • planning to move Massachusetts in the next year
  • currently pregnant
  • institutionalized (i.e.: hospital, prison, etc.).

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

MeSH Terms

Conditions

Feeding BehaviorObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Josiemer Mattei, PhD

    Harvard Chan School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
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

October 14, 2022

First Posted

October 21, 2022

Study Start

July 13, 2022

Primary Completion

April 29, 2024

Study Completion

May 2, 2024

Last Updated

May 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Study personnel will manage and distribute the data generated from the study with other investigators observing NIH policy on the dissemination and sharing of research results. Study information and requests for data will be available immediately upon the data being coded and properly revised for quality control after culmination of the study; deidentified data will be available upon request.

Locations