Feasibility and Acceptability of a Beverage Intervention for Hispanic Adults

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity Hypercholesterolemia Hyperglycemia Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mediterranean Lemonade Consumption

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.

Group Type EXPERIMENTAL

Mediterranean Lemonade

Intervention Type OTHER

All participants will be advised to consume all of the beverage assigned (mediterranean lemonade) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided.

Green Tea Consumption

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.

Group Type EXPERIMENTAL

Green Tea

Intervention Type OTHER

All participants will be advised to consume all of the beverage assigned (green tea) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided.

Flavored Water Consumption

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.

Group Type PLACEBO_COMPARATOR

Flavored Water

Intervention Type OTHER

All participants will be advised to consume all of the beverage assigned (flavored water) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided.

Interventions

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Mediterranean Lemonade

All participants will be advised to consume all of the beverage assigned (mediterranean lemonade) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided.

Intervention Type OTHER

Green Tea

All participants will be advised to consume all of the beverage assigned (green tea) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided.

Intervention Type OTHER

Flavored Water

All participants will be advised to consume all of the beverage assigned (flavored water) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided.

Intervention Type OTHER

Other Intervention Names

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Beverage Consumption Intervention Beverage Consumption Intervention Beverage Consumption Intervention

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes