Behavioral plant-based dietary intervention for Metabolic Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sansum Diabetes Research Institute, Santa Barbara, CA
Metabolic Diseases+1 More
Behavioral plant-based dietary intervention - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Metabolic Diseases
  • Obesity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Baseline and immediately after the intervention at 6 months

Month 6
Blood Pressure
Body weight
Fat mass and fat free mass
Insulin Clearance
Plasma Lipids
β-cell function
Month 6
Program acceptability from community health workers and study participants

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Standard Care
1 of 2
Behavioral and Plant-based Dietary Intervention
1 of 2
Active Control
Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Behavioral plant-based dietary intervention · No Placebo Group · N/A

Behavioral and Plant-based Dietary Intervention
Behavioral
Experimental Group · 1 Intervention: Behavioral plant-based dietary intervention · Intervention Types: Behavioral
Standard Care
Behavioral
ActiveComparator Group · 1 Intervention: Standard care · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and immediately after the intervention at 6 months
Closest Location: Sansum Diabetes Research Institute · Santa Barbara, CA
Photo of california 1Photo of california 2Photo of california 3
2008First Recorded Clinical Trial
2 TrialsResearching Metabolic Diseases
50 CompletedClinical Trials

Who is running the clinical trial?

Sansum Diabetes Research InstituteOTHER
35 Previous Clinical Trials
2,417 Total Patients Enrolled
1 Trials studying Metabolic Diseases
100 Patients Enrolled for Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,094 Previous Clinical Trials
5,051,453 Total Patients Enrolled
20 Trials studying Metabolic Diseases
5,621 Patients Enrolled for Metabolic Diseases
Washington University School of MedicineLead Sponsor
1,772 Previous Clinical Trials
2,270,641 Total Patients Enrolled
7 Trials studying Metabolic Diseases
600 Patients Enrolled for Metabolic Diseases
Miriam Jacome Sosa, PhDPrincipal InvestigatorWashington University School of Medicine

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are of Hispanic or Latino heritage.
You are 30-42 kilograms per square metre (kg/m²) in body mass index (BMI).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.