Diet, HealthyWELCOMENCT05589740
Culturally Optimized Messages for Latinos
A study testing Culturally tailored healthy eating advice and Standard healthy eating advice in people with Diet, Healthy and Diet Habit, run by Harvard School of Public Health (HSPH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Diet Habit, Obesity
- What is being tested?
- Culturally tailored healthy eating advice and Standard healthy eating advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2022to 2 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard TH Chan School of Public Health
Boston, Massachusetts, 02115
About this study
Official title: Wellness With Culturally Optimized Messages for Ethnic-diverse Latinos
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.
Read the detailed description
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. The WELCOME study will be based on the RE-AIM framework with improved reach, adoption, implementation, and maintenance strategies. The intervention arm is a deep-structure cultural tailored text messages for distinct Latino heritages (e.g., Caribbean and non-Caribbean) informed by mixed-methods formative research, compared to surface-level healthy eating messages based on the USDA My Plate Spanish version. The program runs for 6 months: 2-months delivery phase + 2-months reinforcement phase + 2-months maintenance phase.
- Conditions
- Diet, Healthy, Diet Habit, Obesity, Blood Pressure, Psychological
- Being tested
- Culturally tailored healthy eating advice, Standard healthy eating advice
- Medical subject headings
- Feeding Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally tailored healthy eating adviceBehavioural
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 adviceBehavioural
Standard healthy eating education includes strategies, foods, portions, and cooking and eating tips for general dietary recommendations from USDA My Plate
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard healthy eating advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in diet quality score
Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)
Measured: Month 4
Change in levels of adipose risk factor
Estimate the change in the value of waist circumference (cm)
Measured: Month 4
Change in levels of blood pressure risk factor
Estimate the change in the value of systolic and diastolic blood pressure (mmHg)
Measured: Month 4
Change in dietary habits
Determine the change in the score of dietary behaviors (range 1-5)
Measured: Month 4
Secondary outcomes (1)
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
Measured: Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start13 Jul 2022
- Primary completion29 Apr 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josiemer Mattei, Harvard School of Public Health (HSPH)
- Investigators
- Josiemer Mattei, PhD, Principal investigator, Harvard Chan School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589740
- Sponsor's protocol ID
- IRB22-0828
- Acronym
- WELCOME
- Status last verified
- May 2024
- First submitted
- 14 Oct 2022
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wellness With Culturally Optimized Messages for Ethnic-diverse Latinos
- ClinicalTrials.gov ID
- NCT05589740
- Acronym / sponsor ID
- WELCOME / IRB22-0828
- Conditions
- Diet, Healthy, Diet Habit, Obesity, Blood Pressure, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. The WELCOME study will be based on the RE-AIM framework with improved reach, adoption, implementation, and maintenance strategies. The intervention arm is a deep-structure cultural tailored text messages for distinct Latino heritages (e.g., Caribbean and non-Caribbean) informed by mixed-methods formative research, compared to surface-level healthy eating messages based on the USDA My Plate Spanish version. The program runs for 6 months: 2-months delivery phase + 2-months reinforcement phase + 2-months maintenance phase.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Culturally tailored healthy eating adviceIntervention 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. |
| Control | Active comparator | Behavioral: Standard healthy eating adviceControl 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally tailored healthy eating adviceCulturally-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc. | Behavioural | Intervention |
| Standard healthy eating adviceStandard healthy eating education includes strategies, foods, portions, and cooking and eating tips for general dietary recommendations from USDA My Plate | Behavioural | Control |
Primary outcome
Changes in diet quality score
Time frame: Month 4
Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)
Change in levels of adipose risk factor
Time frame: Month 4
Estimate the change in the value of waist circumference (cm)
Change in levels of blood pressure risk factor
Time frame: Month 4
Estimate the change in the value of systolic and diastolic blood pressure (mmHg)
Change in dietary habits
Time frame: Month 4
Determine the change in the score of dietary behaviors (range 1-5)
1 secondary outcome
Changes in diet satisfaction: diet satisfaction scale
Time frame: Month 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josiemer Mattei, PhD principal investigator
Harvard Chan School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally tailored healthy eating advice and Standard healthy eating advice in people with Diet, Healthy and Diet Habit, run by Harvard School of Public Health (HSPH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in diet quality score (time frame: Month 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.