Feasibility and acceptability of a beverage intervention for Hispanic adults: A protocol for a pilot randomized controlled trial

Kristin E. Morrill, Benjamin Aceves, Luis A. Valdez, Cynthia A. Thomson, Iman A. Hakim, Melanie L. Bell, Jessica A. Martinez, David O. Garcia

Research output: Contribution to journalArticle

2 Scopus citations

Abstract

Background: In the U.S., Hispanics have among the highest rates of overweight and obesity when compared to other racial/ethnic groups placing them at a greater risk for obesity-related disease. Identifying intervention strategies to reduce caloric intake and/or improve cardiometabolic health in Hispanics is critical to reducing morbidity and mortality among this large and growing population. Evidence exists to support diet-specific behavioral interventions, including beverage modifications, in reducing obesity-related health risks. However, the acceptability and feasibility of a beverage intervention in obese Hispanic adults has not been robustly evaluated. Methods: The objective of this pilot study is to assess the feasibility and acceptability of a randomized, controlled beverage intervention in 50 obese Hispanic adults ages 18-64 over 8-weeks. Eligible participants were obese (30-50.0 kg/m2), between the ages 18-64, self-identified as Hispanic, and were able to speak, read, and write in either English and/or Spanish. Study recruitment was completed August 2017. Upon the completion of baseline assessments, participants will be randomized to either Mediterranean lemonade, Green Tea, or flavored water control. After completing a 2-week washout period, participants will be asked to consume 32 oz. per day of study beverage for 6-weeks while avoiding all other sources of tea, lemonade, citrus, juice, and other sweetened beverages; water is permissible. Primary outcomes will be recruitment, retention, and acceptability of the intervention strategies. Our study will also evaluate participant-reported tolerance and as an exploratory aim, assess safety/toxicity-related to renal and/or liver function. Fasting blood samples will be collected at baseline and 8-weeks to assess the primary efficacy outcomes: total cholesterol, high-density lipoprotein (HDL), and low-density lipoprotein (LDL). Secondary outcomes include fasting glucose, hemoglobin A1c (HbA1c), and high-sensitivity C-reactive protein (hs-CRP). Discussion: This pilot study will provide important feasibility, safety, and early efficacy data necessary to design a larger, adequately-powered randomized controlled trial. Trial registration: NCT02911753 (ClinicalTrials.gov). Registered September 19, 2016. Last updated November 1, 2017.

Original languageEnglish (US)
Article number16
JournalNutrition Journal
Volume17
Issue number1
DOIs
StatePublished - Feb 9 2018

Keywords

  • Green tea
  • Hispanic
  • Mediterranean lemonade
  • Sugar-sweetened beverages (SSBs)

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Nutrition and Dietetics

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