Feasibility and Acceptability of a Beverage Intervention for Hispanic Adults
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 19, 2016
CompletedFirst Posted
Study publicly available on registry
September 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedResults Posted
Study results publicly available
October 25, 2019
CompletedOctober 25, 2019
October 1, 2017
1.2 years
September 19, 2016
February 13, 2019
October 22, 2019
Conditions
Outcome Measures
Primary Outcomes (7)
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 Outcomes (4)
Change in Total Cholesterol (Baseline and Week 6)
Baseline and Week 6
Change in Fasting Glucose (Baseline and Week 6)
Baseline and Week 6
Change in Hemoglobin A1C (Baseline and Week 6)
Baseline and Week 6
Change in Body Weight (Baseline and Week 6)
Baseline and Week 6
Study Arms (3)
Mediterranean Lemonade Consumption
EXPERIMENTALAll 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
EXPERIMENTALAll 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
PLACEBO COMPARATORAll 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Self-identify as Hispanic
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment
Tucson, Arizona, 85714, United States
Related Publications (5)
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.
PMID: 24570244BACKGROUNDZheng 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.
PMID: 21715508BACKGROUNDHakim 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.
PMID: 11401918BACKGROUNDGarcia 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.
PMID: 30451147DERIVEDMorrill 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.
PMID: 29426328DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was short in duration. It is possible that this was not an adequate amount of time to observe changes in our primary outcomes. In addition, the small sample size may have reduced effect size, thus hindering our capacity to detect changes.
Results Point of Contact
- Title
- David O. Garcia, PhD, FACSM
- Organization
- University of Arizona
Study Officials
- PRINCIPAL INVESTIGATOR
David O Garcia, PhD
University of Arizona
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2016
First Posted
September 22, 2016
Study Start
June 1, 2016
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
October 25, 2019
Results First Posted
October 25, 2019
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share