N/A
N=50
Feasibility and Acceptability of a Beverage Intervention for Hispanic Adults
Obesity · Hypercholesterolemia · Hyperglycemia · Hypertriglyceridemia
Bottom Line
View on ClinicalTrials.gov: NCT02911753 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Study Recruitment: Interest in Participation — 279 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mediterranean Lemonade (Other); Green Tea (Other); Flavored Water (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Arizona
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Study Recruitment: Interest in Participation |
279 | — |
| PRIMARY Study Recruitment: Screened for Eligibility |
236 | — |
| PRIMARY Study Recruitment: Eligibility |
104 | — |
| PRIMARY Study Recruitment: Ineligibility |
132 | — |
| PRIMARY Enrollment |
52 | — |
| PRIMARY Retention |
44 | — |
| PRIMARY Treatment Satisfaction |
3.3; 3.4; 3.3 | — |
| SECONDARY Change in Total Cholesterol (Baseline and Week 6) |
-13.2; -1.67; -3.9 | — |
| SECONDARY Change in Fasting Glucose (Baseline and Week 6) |
-1.40; 5.2; 3.3 | — |
| SECONDARY Change in Hemoglobin A1C (Baseline and Week 6) |
-0.02; 0.05; 0.04 | — |
| SECONDARY Change in Body Weight (Baseline and Week 6) |
-1.8; -0.12; -0.36 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02911753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.