Feasibility and Acceptability of a Beverage Intervention for Hispanic Adults

Study Overview
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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.

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.

Official Title
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Feasibility and Acceptability of a Beverage Intervention for Hispanic Adults

Conditions
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Obesity, Hypercholesterolemia, Hyperglycemia, Hypertriglyceridemia

Intervention / Treatment
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* Other: Mediterranean Lemonade
* Other: Green Tea
* Other: Flavored Water


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediterranean Lemonade Consumption<br>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. | Other: Mediterranean Lemonade<br>* 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.<br>* Other names: Beverage Consumption Intervention;|
| Experimental: Green Tea Consumption<br>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. | Other: Green Tea<br>* 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.<br>* Other names: Beverage Consumption Intervention;|
| Placebo Comparator: Flavored Water Consumption<br>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. | Other: Flavored Water<br>* 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.<br>* Other names: Beverage Consumption Intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Recruitment: Interest in Participation | The number of Hispanic adults who contact the researchers and express interest in participation. | Baseline | 
| Study Recruitment: Screened for Eligibility | The number of Hispanic adults screened for eligibility | Baseline | 
| Study Recruitment: Eligibility | The number of Hispanic adults eligible for study inclusion. | Baseline | 
| Study Recruitment: Ineligibility | The number of Hispanic adults ineligible for study inclusion. | Baseline | 
| Enrollment | The number of Hispanic adults enrolled in the study. | Baseline | 
| Retention | Retention will be measured as the number of participants who remain in the study at 6 weeks. | Week 6 | 
| Treatment Satisfaction | 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. | Week 6 | 

Secondary Outcome Measures

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