ObesitySB PilotNCT05444595
Behavioral Plant-Based Dietary Intervention in Latinos
A study testing Behavioral plant-based dietary intervention in people with Obesity and Metabolic Disease, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The Aims of this study are 1) to develop a traditional plant-based diet that is palatable and acceptable to the Latino population and which contains the appropriate calorie and macronutrient composition needed to lose weight and improve metabolic function and; 2) to develop a culturally sensitive [based on previous… Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Disease
- What is being tested?
- Behavioral plant-based dietary intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2023to 31 Jan 2025
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-reported Hispanic and/or Latino heritage
- Body Mass Index (BMI) 30-42 kg/m²
- HbA1c ≤ 6.4%
Who cannot join
- Previous diagnosis of diabetes
- Unstable weight (≥4% during the last 2 months prior to study enrollment)
- Severe cardiovascular disease within the 6 months prior to study enrollment
- Severe organ system dysfunction
- active substance abuse with alcohol or drugs
- Severe anemia
Show all 9Show fewer
- Pregnant or breastfeeding
- Use of medications that are known to affect the study outcome measures
- Persons who are not able to grant voluntary informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
Official title: A Behavioral and Plant-Based Dietary Intervention to Improve Metabolic Health and Diabetes Risk Factors in an Underserved Latino Population
The Aims of this study are 1) to develop a traditional plant-based diet that is palatable and acceptable to the Latino population and which contains the appropriate calorie and macronutrient composition needed to lose weight and improve metabolic function and; 2) to develop a culturally sensitive [based on previous literature and stakeholder input] lifestyle intervention program, that will be delivered by community health workers [CHWs], that focuses on consuming a traditional plant-based diet and overcoming the barriers to incorporating this dietary therapy as part of the family lifestyle but with a focus on the adult participant with obesity. Ultimately, in Aim 3 the investigators will conduct a 16-week randomized controlled trial (RCT) in 40 Latino adults with obesity [20 control, 20 treatment] to evaluate the intervention's: i) clinical efficacy; ii) fidelity of the implementation by CHWs; and iii) acceptance by CHWs and study participants.
- Conditions
- Obesity, Metabolic Disease
- Being tested
- Behavioral plant-based dietary intervention, Standard care
- Keywords
- Latinos, Obesity, Plant-based diet
- Medical subject headings
- Obesity, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral plant-based dietary interventionBehavioural
Participants will meet with community health workers to receive information focused on healthy eating and consuming a traditional plant-based diet in a group format for the first few months followed by individual check-ins.
Standard careBehavioural
Participants will meet with community health workers to receive general health information through individual check-ins.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral and Plant-based Dietary Intervention | Experimental | In this arm, participants will receive the behavioral plant-based intervention from community health workers. Receives: Behavioral: Behavioral plant-based dietary intervention |
| Standard Care | Active comparator | In this arm, participants will receive the standard care intervention from community health workers. Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Percent change in body weight from baseline to post-intervention
Measured: Baseline and immediately after the intervention at 6 months
Secondary outcomes (6)
Fat mass and fat free mass
Fat mass and fat free mass will be assessed using dual-energy x-ray absorptiometry (DXA)
Measured: Baseline and immediately after the intervention at 6 months
β-cell function
β-cell function will be assessed from a modified 3-hour oral glucose tolerance test
Measured: Baseline and immediately after the intervention at 6 months
Insulin Clearance
Insulin clearance will be assessed from a modified 3-hour oral glucose tolerance test
Measured: Baseline and immediately after the intervention at 6 months
Plasma Lipids
Fasting plasma lipid profile will be assessed by routine blood tests
Measured: Baseline and immediately after the intervention at 6 months
Blood pressure
Systolic and diastolic blood pressure will be measured
Measured: Baseline and immediately after the intervention at 6 months
Program acceptability from community health workers and study participants
Community health workers' and study participants' perceptions of program acceptability via questionnaire
Measured: Immediately after the intervention at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start24 Aug 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Why it stopped: Administrative reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Sansum Diabetes Research Institute
- Responsible party
- Sponsor
- Investigators
- Miriam Jacome Sosa, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444595
- Sponsor's protocol ID
- 202308026
- Acronym
- SB Pilot
- Status last verified
- Jul 2026
- First submitted
- 21 Jun 2022
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Behavioral and Plant-Based Dietary Intervention to Improve Metabolic Health and Diabetes Risk Factors in an Underserved Latino Population
- ClinicalTrials.gov ID
- NCT05444595
- Acronym / sponsor ID
- SB Pilot / 202308026
- Conditions
- Obesity, Metabolic Disease
- Keywords
- Latinos, Obesity, Plant-based diet
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administrative reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Sansum Diabetes Research Institute
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 6 Jul 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.
The Aims of this study are 1) to develop a traditional plant-based diet that is palatable and acceptable to the Latino population and which contains the appropriate calorie and macronutrient composition needed to lose weight and improve metabolic function and; 2) to develop a culturally sensitive [based on previous literature and stakeholder input] lifestyle intervention program, that will be delivered by community health workers [CHWs], that focuses on consuming a traditional plant-based diet and overcoming the barriers to incorporating this dietary therapy as part of the family lifestyle but with a focus on the adult participant with obesity. Ultimately, in Aim 3 the investigators will conduct a 16-week randomized controlled trial (RCT) in 40 Latino adults with obesity [20 control, 20 treatment] to evaluate the intervention's: i) clinical efficacy; ii) fidelity of the implementation by CHWs; and iii) acceptance by CHWs and study participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral and Plant-based Dietary Intervention | Experimental | Behavioral: Behavioral plant-based dietary interventionIn this arm, participants will receive the behavioral plant-based intervention from community health workers. |
| Standard Care | Active comparator | Behavioral: Standard careIn this arm, participants will receive the standard care intervention from community health workers. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-reported Hispanic and/or Latino heritage
- Body Mass Index (BMI) 30-42 kg/m²
- HbA1c ≤ 6.4%
Key exclusion criteria (9 listed)
- Previous diagnosis of diabetes
- Unstable weight (≥4% during the last 2 months prior to study enrollment)
- Severe cardiovascular disease within the 6 months prior to study enrollment
- Severe organ system dysfunction
- active substance abuse with alcohol or drugs
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 |
|---|---|---|
| Behavioral plant-based dietary interventionParticipants will meet with community health workers to receive information focused on healthy eating and consuming a traditional plant-based diet in a group format for the first few months followed by individual check-ins. | Behavioural | Behavioral and Plant-based Dietary Intervention |
| Standard careParticipants will meet with community health workers to receive general health information through individual check-ins. | Behavioural | Standard Care |
Primary outcome
Body weight
Time frame: Baseline and immediately after the intervention at 6 months
Percent change in body weight from baseline to post-intervention
6 secondary outcomes
Fat mass and fat free mass
Time frame: Baseline and immediately after the intervention at 6 months
β-cell function
Time frame: Baseline and immediately after the intervention at 6 months
Insulin Clearance
Time frame: Baseline and immediately after the intervention at 6 months
Plasma Lipids
Time frame: Baseline and immediately after the intervention at 6 months
Blood pressure
Time frame: Baseline and immediately after the intervention at 6 months
Program acceptability from community health workers and study participants
Time frame: Immediately after the intervention at 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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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.
Miriam Jacome Sosa, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral plant-based dietary intervention in people with Obesity and Metabolic Disease, run by Washington University School of Medicine 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 3 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: withdrawn, as of the sponsor's last update on 8 Jul 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Body weight (time frame: Baseline and immediately after the intervention at 6 months). 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 8 Jul 2026.