Childhood ObesityNCT05735600
Latinx Family Wellness
A study testing AyuDa Virtual: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English) and AyuDa Written: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English) in people with Childhood Obesity, run by Ana Maria Linares at 2 sites in United States.
Trial summary
Childhood is an opportune time to intervene in obesity because behaviors that are developed during this time can have long-lasting effects and disrupt trajectories of obesity. This proposal aims to test the feasibility (i.e., participant acceptance, adherence, and retention) of a family-oriented intervention "AyUDA"… Read more about this study
- Who is it for?
- Ages 2 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- AyuDa Virtual: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English) and AyuDa Written: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jul 2023to 28 Dec 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 2 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Latinx family of Mexican or Central American descent
- At least one parent 18 years or older; with a child between 2-5 years old and classified as overweight or obese
- Intention to remain in Central Kentucky for at least a year after recruitment
- Access to the internet.
Who cannot join
- n/a
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinica Amiga, UK Primary Care Pediatrics, Kentucky Clinic South
Lexington, Kentucky, 40504
Polk Dalton Clinic
Lexington, Kentucky, 40507
About this study
Official title: Leveraging Cultural Health Beliefs and Actions to Improve Latinx Family Wellness
Childhood is an opportune time to intervene in obesity because behaviors that are developed during this time can have long-lasting effects and disrupt trajectories of obesity. This proposal aims to test the feasibility (i.e., participant acceptance, adherence, and retention) of a family-oriented intervention "AyUDA" (Aprender y Utilizar Decisiones Apreciables-Learning and Utilizing Significant Choices). The culturally tailored, two-arm adapted intervention to engage Latinx parents in healthy feeding and lifestyle practices for their children 2-5 years old, thereby reducing early childhood overweight and obesity. The investigators will use concepts of the Social-Ecological Framework for Obesity among Latinx, and the Social Learning Theory that emphasizes the importance of observing, modeling, and imitating behaviors. This approach includes a community engagement partnership with one clinic that serves a great number of Latinx families with 2-5 aged children in Central Kentucky (General Pediatric Clinic-Clinica Amiga). The investigators propose a two-arm randomized clinical trial (RCT) randomly assigning participants to either a telehealth deep cultural level group or a culturally traditional educational group in a sample of 40 Latinx families who will be followed for six months after the intervention. Moreover, investigators will explore short-term changes of the intervention on dietary behavior changes and anthropometric measurements among family members. The feasibility study will inform effect sizes that will be used to estimate statistical power for a future R01 on Community Level Interventions to Improve Minority Health and Reduce Health Disparities, National Institute of Health (NIH).
Read the detailed description
The feasibility and effectiveness of a family-oriented intervention entitled "AyUDA" will be tested. The AyUDA intervention will provide Latinx families with culturally tailored modules to take control of modifiable behaviors and help them avoid obesogenic behaviors. This study has a longitudinal RCT study design. The study will be conducted in the University of Kentucky Friendly Clinic (Clinica Amiga). Participants will be followed for six months after the intervention. At least one adult who agrees to participate will sign the informed consent and HIPAA authorization, including the children's assent form. We anticipate that recruitment would include non-English speaking subjects due to Latinx self-identity, and for this reason, consent will be obtained in Spanish. The PIs, Co-I, and RP are fluent in English/Spanish and familiar with Latinx culture. Randomization: Randomization occurs after the baseline interview. Researchers will prepare ordered envelopes that contain the treatment assignments, one set for each stratum. Within each stratum, the treatment assignments will be placed in blocks of 10 (i.e., five assignments to each of the treatment conditions). To minimize attrition, complete contact information from participants will be collected and they will be asked to provide the phone number of two individuals who will know how to contact them in the future. Escalating incentives will be provided during data collection encounters to maximize retention. Reminders will be sent monthly for the duration of the study. Data Collection: Data will be collected by the trained RS who are blind to the study conditions at the following times: T1-baseline at recruitment-pre-intervention and randomization, T2-two weeks after the intervention, T3-Three months after the intervention, and T4-Six months after the intervention.
- Conditions
- Childhood Obesity
- Being tested
- AyuDa Virtual: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English), AyuDa Written: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English)
- Keywords
- Childhood Obesity, Latinx, Intervention, Deep level education
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AyuDa Virtual: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English)Behavioural
The intervention was developed based on the Social Learning Theory, considering both environmental and cognitive factors influencing parent behavior and modeling for children. Researchers have modified a five-module virtual intervention from the "Cooking Healthy and Delicious Manual (Cocinando Delicioso y Saludable Manual, Spanish version), which incorporates behavior change strategies for improving diet quality, screen time, physical activity/sedentary behavior, socioeconomic status/food security, and sleep duration.
AyuDa Written: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English)Behavioural
The intervention was developed based on the Social Learning Theory, considering both environmental and cognitive factors influencing parent behavior and modeling for children. Researchers have modified a five-module virtual intervention from the "Cooking Healthy and Delicious Manual (Cocinando Delicioso y Saludable Manual, Spanish version), which incorporates behavior change strategies for improving diet quality, screen time, physical activity/sedentary behavior, socioeconomic status/food security, and sleep duration.
| Study group | Role | What they receive |
|---|---|---|
| Virtual | Experimental | This group will participate in weekly virtual group sessions facilitated by a culturally similar and trained health educator (Promotora). The virtual modules will be on a platform such as Zoom and will last approximately 90 minutes each. Each module will last 60 minutes with the following three components: 1) 15-minute video on behavior change-related module objective, 2) 15-minute vignette/story depicting a family implementing behavior change, and 3) 15-minute discussion on creating goals and overcoming barriers for behavior change pertaining to the module. The remaining 15-minutes will ask participants to share what worked well towards achieving goals set in the prior module Receives: Behavioral: AyuDa Virtual: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English) |
| Traditional | Active comparator | This group will get the same educational materials in writing (slides with information from video, written story, and instructions on goal setting and overcoming barriers) and receive a phone call from one of the researchers each week (5 weeks in a row) to provide an opportunity to respond questions, comments, and provide guidance about following the recommendations of the written material Receives: Behavioral: AyuDa Written: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scores of the Child Feeding Questionnaire
Evaluate change in scores of the Child Feeding Questionnaire (CFQ). A 31-item self-report questionnaire measuring parental beliefs, attitudes, and practices in relation to child feeding. Each item is measured using a 5-point Likert-type scale, with responses across seven factor-based domains. Scores range from 1 to 5 with higher scores indicating higher levels of each domain.
Measured: Baseline and at 1, 3, and 6 months.
Change in scores of the Caregiver's Feeding Style Questionnaire
Evaluate change in scores of the Caregiver's Feeding Style Questionnaire (CFSQ). The CFSQ is a 19-item measure which classifies caregivers into 1 of 4 feeding styles. Items are scored on a 5-point scale (1=never-5=always), with higher scores indicating higher frequency of engagement in a specific feeding style.
Measured: Baseline and at 1, 3, and 6 months.
Recruitment for AyUDA
Percentage of eligible participants enrolled during the planned recruitment period.
Measured: From study start until enrollment closes up to 9 months.
Intervention completion for AyUDA.
Percentage of treatment group participants that complete all intervention sessions
Measured: From enrollment to end of intervention at 6 weeks
Retention for AyUDA.
Percentage of participants retained in the study until the conclusion
Measured: From enrollment to end of study at 8 months
Secondary outcomes (1)
Change in Body Mass Index (BMI)
Evaluation of weight (kilograms) and height (meters) to calculate BMI (kg/m^2) by age and sex following the World Health Organization (WHO) Body mass index percentile by age and sex 2-5 years.
Measured: Baseline and at 6 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start21 Jul 2023
- Primary completion28 Dec 2024
- Study completion28 Dec 2024
Why it stopped: Funding/financial issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies 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
- Model description
- Two complementary theoretical frameworks inform the proposed study. Social-Ecological Framework suggests that families are nested within multiple social contexts that can influence children's weight. At the macro level, policies can shape child obesity by supplementing families' ability to afford food (e.g., food stamps, income supports), at the messo (community) level, the built and social environments influence child obesity by providing or inhibiting access to healthy food options and safe areas to engage in physical activity. Within the family domain, family attributes, behaviors, functioning, and parental factors, directly shape child obesity. AyUDA targets the family domain by centering obesogenic (obesity-promoting) aspects and mechanisms within families. In concert with this domain, investigators draw from Social Learning Theory to account for how to influence change within the family domain by targeting parenting attitudes and behaviors.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ana Maria Linares
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky
- Responsible party
- Sponsor-investigator, Ana Maria Linares, University of Kentucky
- Investigators
- Ana M Linares, DNS, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735600
- Sponsor's protocol ID
- 77822
- Status last verified
- Mar 2025
- First submitted
- 10 Jan 2023
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to make IPD available upon request.
Publications
Williams JE, Kabukuru A, Mayo R, Griffin SF. Commentary: A social-ecological perspective on obesity among Latinos. Ethn Dis. 2011 Autumn;21(4):467-72.
PubMed 22428352Skinner AC, Ravanbakht SN, Skelton JA, Perrin EM, Armstrong SC. Prevalence of Obesity and Severe Obesity in US Children, 1999-2016. Pediatrics. 2018 Mar;141(3):e20173459. doi: 10.1542/peds.2017-3459.
PubMed 29483202Isong IA, Rao SR, Bind MA, Avendano M, Kawachi I, Richmond TK. Racial and Ethnic Disparities in Early Childhood Obesity. Pediatrics. 2018 Jan;141(1):e20170865. doi: 10.1542/peds.2017-0865.
PubMed 29269386Beck AL, Hoeft KS, Takayama JI, Barker JC. Beliefs and practices regarding solid food introduction among Latino parents in Northern California. Appetite. 2018 Jan 1;120:381-387. doi: 10.1016/j.appet.2017.09.023. Epub 2017 Sep 23.
PubMed 28951238
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Cultural Health Beliefs and Actions to Improve Latinx Family Wellness
- ClinicalTrials.gov ID
- NCT05735600
- Acronym / sponsor ID
- 77822
- Conditions
- Childhood Obesity
- Keywords
- Childhood Obesity, Latinx, Intervention, Deep level education
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding/financial issues
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Ana Maria LinaresUniversity, hospital or other
- Collaborators
- University of Kentucky
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 28 Dec 2024 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 21 Feb 2023 (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.
Childhood is an opportune time to intervene in obesity because behaviors that are developed during this time can have long-lasting effects and disrupt trajectories of obesity. This proposal aims to test the feasibility (i.e., participant acceptance, adherence, and retention) of a family-oriented intervention "AyUDA" (Aprender y Utilizar Decisiones Apreciables-Learning and Utilizing Significant Choices). The culturally tailored, two-arm adapted intervention to engage Latinx parents in healthy feeding and lifestyle practices for their children 2-5 years old, thereby reducing early childhood overweight and obesity. The investigators will use concepts of the Social-Ecological Framework for Obesity among Latinx, and the Social Learning Theory that emphasizes the importance of observing, modeling, and imitating behaviors. This approach includes a community engagement partnership with one clinic that serves a great number of Latinx families with 2-5 aged children in Central Kentucky (General Pediatric Clinic-Clinica Amiga). The investigators propose a two-arm randomized clinical trial (RCT) randomly assigning participants to either a telehealth deep cultural level group or a culturally traditional educational group in a sample of 40 Latinx families who will be followed for six months after the intervention. Moreover, investigators will explore short-term changes of the intervention on dietary behavior changes and anthropometric measurements among family members. The feasibility study will inform effect sizes that will be used to estimate statistical power for a future R01 on Community Level Interventions to Improve Minority Health and Reduce Health Disparities, National Institute of Health (NIH).
Detailed description
The feasibility and effectiveness of a family-oriented intervention entitled "AyUDA" will be tested. The AyUDA intervention will provide Latinx families with culturally tailored modules to take control of modifiable behaviors and help them avoid obesogenic behaviors. This study has a longitudinal RCT study design. The study will be conducted in the University of Kentucky Friendly Clinic (Clinica Amiga). Participants will be followed for six months after the intervention. At least one adult who agrees to participate will sign the informed consent and HIPAA authorization, including the children's assent form. We anticipate that recruitment would include non-English speaking subjects due to Latinx self-identity, and for this reason, consent will be obtained in Spanish. The PIs, Co-I, and RP are fluent in English/Spanish and familiar with Latinx culture. Randomization: Randomization occurs after the baseline interview. Researchers will prepare ordered envelopes that contain the treatment assignments, one set for each stratum. Within each stratum, the treatment assignments will be placed in blocks of 10 (i.e., five assignments to each of the treatment conditions). To minimize attrition, complete contact information from participants will be collected and they will be asked to provide the phone number of two individuals who will know how to contact them in the future. Escalating incentives will be provided during data collection encounters to maximize retention. Reminders will be sent monthly for the duration of the study. Data Collection: Data will be collected by the trained RS who are blind to the study conditions at the following times: T1-baseline at recruitment-pre-intervention and randomization, T2-two weeks after the intervention, T3-Three months after the intervention, and T4-Six months after the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two complementary theoretical frameworks inform the proposed study. Social-Ecological Framework suggests that families are nested within multiple social contexts that can influence children's weight. At the macro level, policies can shape child obesity by supplementing families' ability to afford food (e.g., food stamps, income supports), at the messo (community) level, the built and social environments influence child obesity by providing or inhibiting access to healthy food options and safe areas to engage in physical activity. Within the family domain, family attributes, behaviors, functioning, and parental factors, directly shape child obesity. AyUDA targets the family domain by centering obesogenic (obesity-promoting) aspects and mechanisms within families. In concert with this domain, investigators draw from Social Learning Theory to account for how to influence change within the family domain by targeting parenting attitudes and behaviors.
| Arm | Type | Receives |
|---|---|---|
| Virtual | Experimental | Behavioral: AyuDa Virtual: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English)This group will participate in weekly virtual group sessions facilitated by a culturally similar and trained health educator (Promotora). The virtual modules will be on a platform such as Zoom and will last approximately 90 minutes each. Each module will last 60 minutes with the following three components: 1) 15-minute video on behavior change-related module objective, 2) 15-minute vignette/story depicting a family implementing behavior change, and 3) 15-minute discussion on creating goals and overcoming barriers for behavior change pertaining to the module. The remaining 15-minutes will ask participants to share what worked well towards achieving goals set in the prior module |
| Traditional | Active comparator | Behavioral: AyuDa Written: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English)This group will get the same educational materials in writing (slides with information from video, written story, and instructions on goal setting and overcoming barriers) and receive a phone call from one of the researchers each week (5 weeks in a row) to provide an opportunity to respond questions, comments, and provide guidance about following the recommendations of the written material |
Who may qualify
- Ages
- 2 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Latinx family of Mexican or Central American descent
- At least one parent 18 years or older; with a child between 2-5 years old and classified as overweight or obese
- Intention to remain in Central Kentucky for at least a year after recruitment
- Access to the internet.
Key exclusion criteria (1 listed)
- n/a
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 |
|---|---|---|
| AyuDa Virtual: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English)The intervention was developed based on the Social Learning Theory, considering both environmental and cognitive factors influencing parent behavior and modeling for children. Researchers have modified a five-module virtual intervention from the "Cooking Healthy and Delicious Manual (Cocinando Delicioso y Saludable Manual, Spanish version), which incorporates behavior change strategies for improving diet quality, screen time, physical activity/sedentary behavior, socioeconomic status/food security, and sleep duration. | Behavioural | Virtual |
| AyuDa Written: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English)The intervention was developed based on the Social Learning Theory, considering both environmental and cognitive factors influencing parent behavior and modeling for children. Researchers have modified a five-module virtual intervention from the "Cooking Healthy and Delicious Manual (Cocinando Delicioso y Saludable Manual, Spanish version), which incorporates behavior change strategies for improving diet quality, screen time, physical activity/sedentary behavior, socioeconomic status/food security, and sleep duration. | Behavioural | Traditional |
Primary outcome
Change in scores of the Child Feeding Questionnaire
Time frame: Baseline and at 1, 3, and 6 months.
Evaluate change in scores of the Child Feeding Questionnaire (CFQ). A 31-item self-report questionnaire measuring parental beliefs, attitudes, and practices in relation to child feeding. Each item is measured using a 5-point Likert-type scale, with responses across seven factor-based domains. Scores range from 1 to 5 with higher scores indicating higher levels of each domain.
Change in scores of the Caregiver's Feeding Style Questionnaire
Time frame: Baseline and at 1, 3, and 6 months.
Evaluate change in scores of the Caregiver's Feeding Style Questionnaire (CFSQ). The CFSQ is a 19-item measure which classifies caregivers into 1 of 4 feeding styles. Items are scored on a 5-point scale (1=never-5=always), with higher scores indicating higher frequency of engagement in a specific feeding style.
Recruitment for AyUDA
Time frame: From study start until enrollment closes up to 9 months.
Percentage of eligible participants enrolled during the planned recruitment period.
Intervention completion for AyUDA.
Time frame: From enrollment to end of intervention at 6 weeks
Percentage of treatment group participants that complete all intervention sessions
Retention for AyUDA.
Time frame: From enrollment to end of study at 8 months
Percentage of participants retained in the study until the conclusion
1 secondary outcome
Change in Body Mass Index (BMI)
Time frame: Baseline and at 6 months after the intervention.
Results and safety
The study was stopped early (reason given: Funding/financial issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Background: PubMed 22428352Williams JE, Kabukuru A, Mayo R, Griffin SF. Commentary: A social-ecological perspective on obesity among Latinos. Ethn Dis. 2011 Autumn;21(4):467-72.
- Background: PubMed 29483202Skinner AC, Ravanbakht SN, Skelton JA, Perrin EM, Armstrong SC. Prevalence of Obesity and Severe Obesity in US Children, 1999-2016. Pediatrics. 2018 Mar;141(3):e20173459. doi: 10.1542/peds.2017-3459.
- Background: PubMed 29269386Isong IA, Rao SR, Bind MA, Avendano M, Kawachi I, Richmond TK. Racial and Ethnic Disparities in Early Childhood Obesity. Pediatrics. 2018 Jan;141(1):e20170865. doi: 10.1542/peds.2017-0865.
- Background: PubMed 28951238Beck AL, Hoeft KS, Takayama JI, Barker JC. Beliefs and practices regarding solid food introduction among Latino parents in Northern California. Appetite. 2018 Jan 1;120:381-387. doi: 10.1016/j.appet.2017.09.023. Epub 2017 Sep 23.
- Individual participant dataSharing planned: Yes. We plan to make IPD 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.
Ana M Linares, DNS principal investigator
University of Kentucky
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AyuDa Virtual: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English) and AyuDa Written: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English) in people with Childhood Obesity, run by Ana Maria Linares at 2 sites 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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Funding/financial issues). Results are not available in the source record.
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?
Change in scores of the Child Feeding Questionnaire (time frame: Baseline and at 1, 3, and 6 months.). The study lists 5 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 NCT05735600, which also lists 4 linked publications.
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 17 Mar 2025; AzTrials last refreshed its copy on 31 Oct 2026.