Feasibility and Acceptability of a Beverage Intervention for Hispanic Adults

University of Arizona

Status: Completed

Conditions: Hyperglycemia; Hypertriglyceridemia; Hypercholesterolemia; Obesity

Treatments: Other: Flavored Water; Other: Green Tea; Other: Mediterranean Lemonade

Study type: Interventional

Funder types: Other

Identifiers

NCT02911753

1606621176

Details and patient eligibility

About

This study aims to 1) assess the feasibility and acceptability of a prescribed beverage intervention in 50 obese Hispanic adults ages 18-64 years over 6 weeks; and 2) assess preliminary effects of the beverage intervention on cholesterol and triglyceride levels as well as other markers of health such as blood pressure, glucose and markers of inflammation. This project, if successful, will provide early evidence that targeting dietary behavior around beverage intake could be a novel and easily adopted approach to reduce the burden or delay the onset of metabolic abnormalities in obese Hispanic adults. The expected outcome of the proposed project is the identification of feasible and appropriate beverage intervention strategies to improve engagement and adherence to dietary modification approaches for control of metabolic health indicators in this vulnerable ethnic group.

Full description

In the U.S., Hispanics have the highest rates of overweight and obesity when compared to other racial/ethnic groups placing them at a greater risk for obesity-related disease. Yet, current literature is limited to information on best practices to engage Hispanics in health-promoting lifestyle interventions. Without this information the health consequences associated with obesity, including high blood pressure, elevated blood glucose and high cholesterol, will continue. Evidence exists to support diet-specific behavioral interventions in reducing obesity-related health risks. Among the more adoptable interventions to date are efforts targeting beverage intake. Yet, there are limited data to suggest these approaches are effective for Hispanics despite this being the fastest growing and highest burdened group for obesity-related disease within the U.S. population.

This study aims to 1) assess the feasibility and acceptability of a prescribed beverage intervention in 50 obese Hispanic adults ages 18-64 years over 6 weeks; 2) assess preliminary effects of the beverage intervention on cholesterol and triglyceride levels as well as other markers of health such as blood pressure, glucose and markers of inflammation. This project, if successful, will provide early evidence that targeting dietary behavior around beverage intake could be a novel and easily adopted approach to reduce the burden or delay the onset of metabolic abnormalities in obese Hispanic adults. The expected outcome of the proposed project is the identification of feasible and appropriate beverage intervention strategies to improve engagement and adherence to dietary modification approaches for control of metabolic health indicators in this vulnerable ethnic group.

Enrollment: 50 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Self-identify as Hispanic
• 18-64 years of age
• BMI between 30 to 50.0 kg/m²
• Ability to participate in and provide informed consent.
• Speak, read, and write either English and/or Spanish

Exclusion criteria

• Diagnosis of diabetes mellitus
• History of liver disease
• Current medication for glucose control, cholesterol control; uncontrolled BP
• Current eating disorders such as anorexia nervosa, bulimia, etc. (likely to make adherence to prescribed beverage intake difficult)
• Current alcohol or substance abuse
• Currently treated for psychological issues (i.e. depression, bipolar disorder, etc.), taking psychotropic medications with the previous 12 months, or hospitalized for depression within the previous 5 years
• Report exercise on ≥3 days per week for ≥ 20 minutes per day over the past 3 months
• Report weight loss of ≥5% or participating in a weight reduction diet program in the past 3 months
• Report plans to relocate to a location that limits their access to the study site or having employment, personal, or travel commitments that prohibit attendance to all of the scheduled assessments
• Report consumption of ≥ 1 cup of green tea daily and not willing to complete 2 week run-in period
• Report consumption of ≥ 1 cup of citrus fruit daily and not willing to complete 2 week run-in period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 3 patient groups, including a placebo group

Mediterranean Lemonade Consumption

Experimental group

Description:

All participants will be asked to consume 32 ounces daily of Mediterranean Lemonade. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks.

Treatment:

Other: Mediterranean Lemonade

Green Tea Consumption

Experimental group

Description:

All participants will be asked to consume 32 ounces daily of Green Tea. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks.

Treatment:

Other: Green Tea

Flavored Water Consumption

Placebo Comparator group

Description:

All participants will be asked to consume 32 ounces daily of Flavored Water. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks.

Treatment:

Other: Flavored Water