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Feasibility and Acceptability of a Beverage Intervention for Hispanic Adults

Primary Purpose

Obesity, Hypercholesterolemia, Hyperglycemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mediterranean Lemonade
Green Tea
Flavored Water
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts 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

Sites / Locations

  • University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Mediterranean Lemonade Consumption

Green Tea Consumption

Flavored Water Consumption

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Study Recruitment: Interest in Participation
The number of Hispanic adults who contact the researchers and express interest in participation.
Study Recruitment: Screened for Eligibility
The number of Hispanic adults screened for eligibility
Study Recruitment: Eligibility
The number of Hispanic adults eligible for study inclusion.
Study Recruitment: Ineligibility
The number of Hispanic adults ineligible for study inclusion.
Enrollment
The number of Hispanic adults enrolled in the study.
Retention
Retention will be measured as the number of participants who remain in the study at 6 weeks.
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.

Secondary Outcome Measures

Change in Total Cholesterol (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)
Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in glucose.
Change in Hemoglobin A1C (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)
Body weight was measured on a digital scale to assess change in body weight over the intervention period.

Full Information

First Posted
September 19, 2016
Last Updated
October 22, 2019
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT02911753
Brief Title
Feasibility and Acceptability of a Beverage Intervention for Hispanic Adults
Official Title
Feasibility and Acceptability of a Beverage Intervention for Hispanic Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Hypercholesterolemia, Hyperglycemia, Hypertriglyceridemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mediterranean Lemonade Consumption
Arm Type
Experimental
Arm 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.
Arm Title
Green Tea Consumption
Arm Type
Experimental
Arm 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.
Arm Title
Flavored Water Consumption
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Mediterranean Lemonade
Other Intervention Name(s)
Beverage Consumption Intervention
Intervention Description
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
Intervention Name(s)
Green Tea
Other Intervention Name(s)
Beverage Consumption Intervention
Intervention Description
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
Intervention Name(s)
Flavored Water
Other Intervention Name(s)
Beverage Consumption Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Study Recruitment: Interest in Participation
Description
The number of Hispanic adults who contact the researchers and express interest in participation.
Time Frame
Baseline
Title
Study Recruitment: Screened for Eligibility
Description
The number of Hispanic adults screened for eligibility
Time Frame
Baseline
Title
Study Recruitment: Eligibility
Description
The number of Hispanic adults eligible for study inclusion.
Time Frame
Baseline
Title
Study Recruitment: Ineligibility
Description
The number of Hispanic adults ineligible for study inclusion.
Time Frame
Baseline
Title
Enrollment
Description
The number of Hispanic adults enrolled in the study.
Time Frame
Baseline
Title
Retention
Description
Retention will be measured as the number of participants who remain in the study at 6 weeks.
Time Frame
Week 6
Title
Treatment Satisfaction
Description
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.
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Change in Total Cholesterol (Baseline and Week 6)
Description
Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in total cholesterol.
Time Frame
Baseline and Week 6
Title
Change in Fasting Glucose (Baseline and Week 6)
Description
Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in glucose.
Time Frame
Baseline and Week 6
Title
Change in Hemoglobin A1C (Baseline and Week 6)
Description
Fasting blood samples (venipuncture) were collected for the purpose of examining changes in hemoglobin A1C.
Time Frame
Baseline and Week 6
Title
Change in Body Weight (Baseline and Week 6)
Description
Body weight was measured on a digital scale to assess change in body weight over the intervention period.
Time Frame
Baseline and Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David O Garcia, PhD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85714
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24570244
Citation
Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
Results Reference
background
PubMed Identifier
21715508
Citation
Zheng XX, Xu YL, Li SH, Liu XX, Hui R, Huang XH. Green tea intake lowers fasting serum total and LDL cholesterol in adults: a meta-analysis of 14 randomized controlled trials. Am J Clin Nutr. 2011 Aug;94(2):601-10. doi: 10.3945/ajcn.110.010926. Epub 2011 Jun 29.
Results Reference
background
PubMed Identifier
11401918
Citation
Hakim IA, Hartz V, Harris RB, Balentine D, Weisgerber UM, Graver E, Whitacre R, Alberts D. Reproducibility and relative validity of a questionnaire to assess intake of black tea polyphenols in epidemiological studies. Cancer Epidemiol Biomarkers Prev. 2001 Jun;10(6):667-78.
Results Reference
background
PubMed Identifier
30451147
Citation
Garcia DO, Morrill KE, Aceves B, Valdez LA, Rabe BA, Bell ML, Hakim IA, Martinez JA, Thomson CA. Feasibility and acceptability of a beverage intervention for Hispanic adults: results from a pilot randomized controlled trial. Public Health Nutr. 2019 Mar;22(3):542-552. doi: 10.1017/S1368980018003051. Epub 2018 Nov 19.
Results Reference
derived
PubMed Identifier
29426328
Citation
Morrill KE, Aceves B, Valdez LA, Thomson CA, Hakim IA, Bell ML, Martinez JA, Garcia DO. Feasibility and acceptability of a beverage intervention for Hispanic adults: a protocol for a pilot randomized controlled trial. Nutr J. 2018 Feb 9;17(1):16. doi: 10.1186/s12937-018-0329-y.
Results Reference
derived

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Feasibility and Acceptability of a Beverage Intervention for Hispanic Adults

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