Behavioral Plant-Based Dietary Intervention in Latinos (SBPlant)
Primary Purpose
Obesity, Metabolic Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral plant-based dietary intervention
Standard care
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Latinos, Obesity, Plant-based diet
Eligibility Criteria
Inclusion Criteria:
- Self-reported Hispanic and/or Latino heritage
- Body Mass Index (BMI) 30-42 kg/m²
- HbA1c ≤ 6.4%
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Sansum Diabetes Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Behavioral and Plant-based Dietary Intervention
Standard Care
Arm Description
In this arm, participants will receive the behavioral plant-based intervention from community health workers.
In this arm, participants will receive the standard care intervention from community health workers.
Outcomes
Primary Outcome Measures
Body weight
Percent change in body weight from baseline to post-intervention
Secondary Outcome Measures
Fat mass and fat free mass
Fat mass and fat free mass will be assessed using dual-energy x-ray absorptiometry (DXA)
β-cell function
β-cell function will be assessed from a modified 3-hour oral glucose tolerance test
Insulin Clearance
Insulin clearance will be assessed from a modified 3-hour oral glucose tolerance test
Plasma Lipids
Fasting plasma lipid profile will be assessed by routine blood tests
Blood pressure
Systolic and diastolic blood pressure will be measured
Program acceptability from community health workers and study participants
Community health workers' and study participants' perceptions of program acceptability via questionnaire
Full Information
NCT ID
NCT05444595
First Posted
June 21, 2022
Last Updated
July 12, 2023
Sponsor
Washington University School of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Sansum Diabetes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05444595
Brief Title
Behavioral Plant-Based Dietary Intervention in Latinos
Acronym
SBPlant
Official Title
A Behavioral and Plant-Based Dietary Intervention to Improve Metabolic Health and Diabetes Risk Factors in an Underserved Latino Population
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Sansum Diabetes Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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. The current status of the RCT is not yet ready to begin. The current activities are only preparatory to research, and/or activities that do not involve human subjects research (Aims 1 and 2). The investigators will submit a separate project before conducting the human subjects research that is described in this In-Concept project.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic Disease
Keywords
Latinos, Obesity, Plant-based diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Behavioral and Plant-based Dietary Intervention
Arm Type
Experimental
Arm Description
In this arm, participants will receive the behavioral plant-based intervention from community health workers.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
In this arm, participants will receive the standard care intervention from community health workers.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral plant-based dietary intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Intervention Description
Participants will meet with community health workers to receive general health information through individual check-ins.
Primary Outcome Measure Information:
Title
Body weight
Description
Percent change in body weight from baseline to post-intervention
Time Frame
Baseline and immediately after the intervention at 6 months
Secondary Outcome Measure Information:
Title
Fat mass and fat free mass
Description
Fat mass and fat free mass will be assessed using dual-energy x-ray absorptiometry (DXA)
Time Frame
Baseline and immediately after the intervention at 6 months
Title
β-cell function
Description
β-cell function will be assessed from a modified 3-hour oral glucose tolerance test
Time Frame
Baseline and immediately after the intervention at 6 months
Title
Insulin Clearance
Description
Insulin clearance will be assessed from a modified 3-hour oral glucose tolerance test
Time Frame
Baseline and immediately after the intervention at 6 months
Title
Plasma Lipids
Description
Fasting plasma lipid profile will be assessed by routine blood tests
Time Frame
Baseline and immediately after the intervention at 6 months
Title
Blood pressure
Description
Systolic and diastolic blood pressure will be measured
Time Frame
Baseline and immediately after the intervention at 6 months
Title
Program acceptability from community health workers and study participants
Description
Community health workers' and study participants' perceptions of program acceptability via questionnaire
Time Frame
Immediately after the intervention at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Self-reported Hispanic and/or Latino heritage
Body Mass Index (BMI) 30-42 kg/m²
HbA1c ≤ 6.4%
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Jacome Sosa, PhD
Phone
(314) 362-4884
Email
mjacome@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rick Stein, PhD
Phone
314-286-0077
Email
rstein@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam Jacome Sosa, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sansum Diabetes Research Institute
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raul Bastarrachea, MD
Phone
805-682-7638
Email
rbasta@sansum.org
12. IPD Sharing Statement
Learn more about this trial
Behavioral Plant-Based Dietary Intervention in Latinos
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