Feasibility and Acceptability of a Beverage Intervention for Hispanic Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Study Recruitment: Eligibility
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Mediterranean Lemonade Consumption
All 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.
干预措施: Mediterranean Lemonade (Other)
Flavored Water Consumption
All 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.
干预措施: Flavored Water (Other)
Green Tea Consumption
All 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.
干预措施: Green Tea (Other)
结局指标
主要结局
Study Recruitment: Eligibility
时间窗: Baseline
The number of Hispanic adults eligible for study inclusion.
Study Recruitment: Ineligibility
时间窗: Baseline
The number of Hispanic adults ineligible for study inclusion.
Enrollment
时间窗: Baseline
The number of Hispanic adults enrolled in the study.
Study Recruitment: Interest in Participation
时间窗: Baseline
The number of Hispanic adults who contact the researchers and express interest in participation.
Study Recruitment: Screened for Eligibility
时间窗: Baseline
The number of Hispanic adults screened for eligibility
Retention
时间窗: Week 6
Retention will be measured as the number of participants who remain in the study at 6 weeks.
Treatment Satisfaction
时间窗: Week 6
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.
次要结局
- 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)
