Diet, HealthyNCT04724382
Healthy Eating Education 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 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. 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
- 29 Apr 2019to 22 Sep 2021
- 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
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
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: Culturally-tailored Healthy Eating Education Intervention for Latinos in Massachusetts
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.
- 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
| 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 reinforcement phase of 2-months will follow to repeat the 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 reinforcement phase of 2-months will follow to repeat the 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: 4 months
Changes in diet habits
Determine the change in the frequency of dietary behaviors (percent)
Measured: 4 months
Secondary outcomes (3)
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: 4 months
Changes in attitude for eating: attitudes scale
Determine the change in the score of the attitudes scale (range 0-20; with positive and negative subscales for more attitudes towards healthy eating)
Measured: 4 months
Changes in reasons for eating: reasons scale
Determine the change in the score of the reasons scale (range 0-15; fewer to more reasons to eat healthy)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start29 Apr 2019
- Primary completion22 Sep 2021
- Study completion22 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724382
- Sponsor's protocol ID
- IRB13-1332
- Status last verified
- Oct 2023
- First submitted
- 22 Jan 2021
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38445250
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally-tailored Healthy Eating Education Intervention for Latinos in Massachusetts
- ClinicalTrials.gov ID
- NCT04724382
- Acronym / sponsor ID
- IRB13-1332
- 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
- 29 Apr 2019 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 22 Sep 2021 (actual)
- First posted
- 26 Jan 2021 (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 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.
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 reinforcement phase of 2-months will follow to repeat the 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 reinforcement phase of 2-months will follow to repeat the 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)
- 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
Key exclusion criteria (9 listed)
- 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
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 | Behavioural | Control |
Primary outcome
Changes in diet quality score
Time frame: 4 months
Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)
Changes in diet habits
Time frame: 4 months
Determine the change in the frequency of dietary behaviors (percent)
3 secondary outcomes
Changes in diet satisfaction: diet satisfaction scale
Time frame: 4 months
Changes in attitude for eating: attitudes scale
Time frame: 4 months
Changes in reasons for eating: reasons scale
Time frame: 4 months
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 26 Oct 2023.
- Derived from this study: PubMed 38445250Mattei 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.
- Individual participant dataSharing planned: Yes. 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 9 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 26 Oct 2023. 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: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04724382, which also lists 1 linked publication.
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 26 Oct 2023.