Feasibility and Acceptability of a Beverage Intervention for Hispanic Adults

Obesity Clinical Trial

Official title:

Feasibility and Acceptability of a Beverage Intervention for Hispanic Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02911753
• Other study ID #: 1606621176
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: August 2017

Study information

• Verified date: October 2017
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperglycemia
• Hypertriglyceridemia
• Obesity

Intervention

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study Recruitment: Interest in Participation	The number of Hispanic adults who contact the researchers and express interest in participation.	Baseline
Primary	Study Recruitment: Screened for Eligibility	The number of Hispanic adults screened for eligibility	Baseline
Primary	Study Recruitment: Eligibility	The number of Hispanic adults eligible for study inclusion.	Baseline
Primary	Study Recruitment: Ineligibility	The number of Hispanic adults ineligible for study inclusion.	Baseline
Primary	Enrollment	The number of Hispanic adults enrolled in the study.	Baseline
Primary	Retention	Retention will be measured as the number of participants who remain in the study at 6 weeks.	Week 6
Primary	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	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
Secondary	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
Secondary	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
Secondary	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