Feasibility and Acceptability of a Beverage Intervention for Hispanic Adults

Not Applicable

Completed

Conditions: Hypercholesterolemia
Hyperglycemia
Obesity
Hypertriglyceridemia

Interventions: Other: Mediterranean Lemonade
Other: Green Tea
Other: Flavored Water

Registration Number: NCT02911753

Lead Sponsor: University of Arizona

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mediterranean Lemonade Consumption	Mediterranean Lemonade	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.
Green Tea Consumption	Green Tea	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.
Flavored Water Consumption	Flavored Water	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.

Primary Outcome Measures

Name	Time	Method
Study Recruitment: Eligibility	Baseline	The number of Hispanic adults eligible for study inclusion.
Study Recruitment: Ineligibility	Baseline	The number of Hispanic adults ineligible for study inclusion.
Enrollment	Baseline	The number of Hispanic adults enrolled in the study.
Retention	Week 6	Retention will be measured as the number of participants who remain in the study at 6 weeks.
Treatment Satisfaction	Week 6	Participants will be asked to rate their overall satisfaction (1- low; 4-high) with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
Study Recruitment: Interest in Participation	Baseline	The number of Hispanic adults who contact the researchers and express interest in participation.
Study Recruitment: Screened for Eligibility	Baseline	The number of Hispanic adults screened for eligibility

Secondary Outcome Measures

Name	Time	Method
Change in Total Cholesterol (Baseline and Week 6)	Baseline and Week 6	Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in total cholesterol.
Change in Fasting Glucose (Baseline and Week 6)	Baseline and Week 6	Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in glucose.
Change in Hemoglobin A1C (Baseline and Week 6)	Baseline and Week 6	Fasting blood samples (venipuncture) were collected for the purpose of examining changes in hemoglobin A1C.
Change in Body Weight (Baseline and Week 6)	Baseline and Week 6	Body weight was measured on a digital scale to assess change in body weight over the intervention period.