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Culturally Tailored Diet Advice for Healthy Eating (WELCOME Trial)
N/A
Recruiting
Led By Josiemer Mattei, PhD
Research Sponsored by Harvard School of Public Health (HSPH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 4
Awards & highlights
WELCOME Trial Summary
This trial aims to create a healthier eating program tailored to Latinos and test if it can improve their diet and health.
Who is the study for?
This trial is for Latinos aged 25-65 living in Massachusetts who have a cellphone capable of texting. They must not be planning to move, be pregnant, institutionalized, or have major health issues like cancer, diabetes, severe heart conditions or dietary restrictions.Check my eligibility
What is being tested?
The study compares the effectiveness of culturally tailored healthy eating advice versus standard advice on diet quality and health outcomes such as body measurements and blood pressure among diverse Latino participants.See study design
What are the potential side effects?
Since this trial involves lifestyle interventions with healthy eating messages rather than medications, there are no typical side effects; however, changes in diet may cause temporary digestive adjustments.
WELCOME Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in dietary habits
Change in levels of adipose risk factor
Change in levels of blood pressure risk factor
+1 moreSecondary outcome measures
Changes in diet satisfaction: diet satisfaction scale
WELCOME Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Culturally tailored healthy eating advice
2019
N/A
~80
Find a Location
Who is running the clinical trial?
Harvard School of Public Health (HSPH)Lead Sponsor
272 Previous Clinical Trials
16,304,936 Total Patients Enrolled
21 Trials studying Obesity
290,206 Patients Enrolled for Obesity
Josiemer Mattei, PhDPrincipal InvestigatorHarvard Chan School of Public Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with cancer, diabetes, or a major stomach or heart condition.I have a cellphone that can send and receive texts and agree to receive study texts.I can understand and communicate in either Spanish or English.I am between 25 and 65 years old.You identify yourself as being of Hispanic/Latino descent.You have 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.I am between 25 and 65 years old.I can understand and communicate in either Spanish or English.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any participants being accepted into this experiment at present?
"Affirmative. According to clinicaltrials.gov, this health investigation is presently looking for participants; the trial was initially published on July 13th 2022 and most recently modified on October 18th 2022. A total of 76 subjects are needed from a single site."
Answered by AI
Am I qualified to participate in this research endeavor?
"For this research endeavour, 76 individuals of Hispanic/Latino heritage between the ages 25-65 y/o residing in Massachusetts for at least a year and not planning to move soon are needed. Additionally, volunteers must possess a cellphone with texting capabilities and agree to have the study send text messages as part of their intervention protocol."
Answered by AI
Does this research project accept participants younger than 40 years of age?
"As delineated by the trial's inclusion criteria, participants need to be of age 25 or above and not exceed 65 years."
Answered by AI
How many test subjects are involved in this clinical trial?
"Affirmative. The clinicaltrials.gov website indicates that this research is actively recruiting participants, commencing on July 13th 2022 and updated most recently on October 18th 2022. There are 76 openings at 1 site of participation."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Harvard TH Chan School of Public Health
What portion of applicants met pre-screening criteria?
Met criteria
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