Behavioral Plant-Based Dietary Intervention in Latinos (SB Pilot)

The Washington University

Status: Withdrawn

Conditions: Obesity; Metabolic Disease

Treatments: Behavioral: Standard care; Behavioral: Behavioral plant-based dietary intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05444595

202308026

Details and patient eligibility

About

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.

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Behavioral and Plant-based Dietary Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Behavioral plant-based dietary intervention

Standard Care

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard care