Clinical trial NCT05444595: Behavioral Plant-Based Dietary Intervention in Latinos
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
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Metabolic Disease
Keywords: Latinos
Obesity
Plant-based diet
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Sansum Diabetes Research Institute
First posted: 2022-07-06
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Body weight
timeFrame: Baseline and immediately after the intervention at 6 months
Secondary outcomes:
measure: Fat mass and fat free mass
timeFrame: Baseline and immediately after the intervention at 6 months
measure: β-cell function
timeFrame: Baseline and immediately after the intervention at 6 months
measure: Insulin Clearance
timeFrame: Baseline and immediately after the intervention at 6 months
measure: Plasma Lipids
timeFrame: Baseline and immediately after the intervention at 6 months
measure: Blood pressure
timeFrame: Baseline and immediately after the intervention at 6 months
measure: Program acceptability from community health workers and study participants
timeFrame: Immediately after the intervention at 6 months
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
Study officials:
affiliation: Washington University School of Medicine
name: Miriam Jacome Sosa, PhD
role: PRINCIPAL_INVESTIGATOR
References: