Plant-Based Diet for Obesity

(SB Pilot Trial)

Overseen By Miriam Jacome Sosa, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must not be taking: Outcome-affecting medications

Disqualifiers: Diabetes, Cardiovascular disease, Organ dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

Trial Summary

What is the purpose of this trial?

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.

Research Team

Miriam Jacome Sosa, PhD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for Latino adults with obesity (BMI of 30-42 kg/m²) who do not have diabetes, severe health conditions, or recent significant weight changes. Participants should not be pregnant, breastfeeding, or using medications that affect the study's outcomes.

Inclusion Criteria

Self-reported Hispanic and/or Latino heritage

HbA1c ≤ 6.4%

Body Mass Index (BMI) 30-42 kg/m²

Exclusion Criteria

I have not had severe heart problems in the last 6 months.

Unstable weight (≥4% during the last 2 months prior to study enrollment)

I have a major organ that is not working properly.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 16-week behavioral plant-based dietary intervention delivered by community health workers

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Behavioral plant-based dietary intervention

Trial Overview The study is testing a culturally sensitive plant-based diet against standard care in Latinos to see if it helps lose weight and improve metabolic health. It involves a 16-week program delivered by community health workers.

Participant Groups

Group I: Behavioral and Plant-based Dietary Intervention Experimental Treatment 1 Intervention

In this arm, participants will receive the behavioral plant-based intervention from community health workers.

Group II: Standard Care Active Control 1 Intervention

In this arm, participants will receive the standard care intervention from community health workers.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Sansum Diabetes Research Institute

Collaborator

Trials

39

Recruited

2,300+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+