- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02911753
Feasibility and Acceptability of a Beverage Intervention for Hispanic Adults
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85714
- University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
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.
Other Names:
|
EXPERIMENTAL: 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.
|
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.
Other Names:
|
PLACEBO_COMPARATOR: 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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Study Recruitment: Interest in Participation
Time Frame: Baseline
|
The number of Hispanic adults who contact the researchers and express interest in participation.
|
Baseline
|
Study Recruitment: Screened for Eligibility
Time Frame: Baseline
|
The number of Hispanic adults screened for eligibility
|
Baseline
|
Study Recruitment: Eligibility
Time Frame: Baseline
|
The number of Hispanic adults eligible for study inclusion.
|
Baseline
|
Study Recruitment: Ineligibility
Time Frame: Baseline
|
The number of Hispanic adults ineligible for study inclusion.
|
Baseline
|
Enrollment
Time Frame: Baseline
|
The number of Hispanic adults enrolled in the study.
|
Baseline
|
Retention
Time Frame: Week 6
|
Retention will be measured as the number of participants who remain in the study at 6 weeks.
|
Week 6
|
Treatment Satisfaction
Time Frame: 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.
|
Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Total Cholesterol (Baseline and Week 6)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David O Garcia, PhD, University of Arizona
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1606621176
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hyperglycemia
-
Mayo ClinicCompletedHospital Hyperglycemia | Post-transplant HyperglycemiaUnited States
-
Zealand University HospitalNot yet recruitingStress Hyperglycemia | Postoperative Hyperglycemia
-
University of CopenhagenUnknownSurgery--Complications | Hyperglycemia Stress | Hyperglycemia Steroid-inducedDenmark
-
University of LeedsCompletedEffect of Food on Postprandial HyperglycemiaUnited Kingdom
-
Emory UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...RecruitingHyperglycemia StressUnited States
-
Loughborough UniversityUniversity of BedfordshireCompletedPostprandial HyperglycemiaUnited Kingdom
-
Centre Hospitalier Universitaire de BesanconEli Lilly and Company; AstraZenecaCompleted
-
Medical University of ViennaCompleted
-
Addis Ababa UniversityCompletedHyperglycemia, Postprandial
-
University of Eastern FinlandFinnsugar LtdCompletedHyperglycemia, PostprandialFinland
Clinical Trials on Mediterranean Lemonade
-
VU University of AmsterdamDutch Heart Foundation; ZonMw: The Netherlands Organisation for Health Research... and other collaboratorsCompleted
-
NestléCompletedNutritional DeficiencyUnited States
-
LI-JU ChenCompletedHeart Failure | Thirst | SalivaTaiwan
-
Newcastle UniversityThe Sheepdrove TrustUnknownHealth StatusGreece, United Kingdom
-
Purdue UniversityMushroom CouncilCompleted
-
Harokopio UniversityNational and Kapodistrian University of AthensCompleted
-
Harokopio UniversityUniversity of AthensCompletedNon-alcoholic Fatty Liver Disease (NAFLD) | Non-alcoholic Steatohepatitis (NASH)Greece
-
Gangnam Severance HospitalUnknown
-
Federico II UniversityCompletedMediterranean Diet | Neuroendocrine Tumours (NETs)Italy
-
Acibadem UniversityCompletedHashimoto Disease | Hashimoto ThyroiditisTurkey