Clinical trial NCT02911753: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Hypercholesterolemia
Hyperglycemia
Hypertriglyceridemia
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Study Recruitment: Interest in Participation
timeFrame: Baseline
measure: Study Recruitment: Screened for Eligibility
timeFrame: Baseline
measure: Study Recruitment: Eligibility
timeFrame: Baseline
measure: Study Recruitment: Ineligibility
timeFrame: Baseline
measure: Enrollment
timeFrame: Baseline
measure: Retention
timeFrame: Week 6
measure: Treatment Satisfaction
timeFrame: Week 6
Secondary outcomes:
measure: Change in Total Cholesterol (Baseline and Week 6)
timeFrame: Baseline and Week 6
measure: Change in Fasting Glucose (Baseline and Week 6)
timeFrame: Baseline and Week 6
measure: Change in Hemoglobin A1C (Baseline and Week 6)
timeFrame: Baseline and Week 6
measure: Change in Body Weight (Baseline and Week 6)
timeFrame: Baseline and Week 6
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment
state: Arizona
Study officials:
affiliation: University of Arizona
name: David O Garcia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.