University of Georgia Mind Your Heart Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Changes in Mindful Eating Behaviors
研究概览
简要总结
The goal of this observational study is to learn if nutrition education can improve eating habits and health outcomes in adults. The main questions it aims to answer are:
- Does participation in a 6-week nutrition education program improve dietary behaviors?
- Does participation in the program improve health measures such as blood lipids, blood pressure, and eye nutrient levels?
Participants will:
- Visit the Institute of Gerontology at the beginning and end of the 6-week study for:
- Blood draws to measure blood lipids (e.g., cholesterol)
- Blood pressure measurement
- Eye exams to assess nutrient levels
- Completion of questionnaires about dietary habits
- Complete online questionnaires before and after the study period
- Participate in the Mind Your Heart program by reviewing 6 online modules over 6 weeks (approximately 20-30 minutes per module)
详细描述
This study examines the efficacy of a 6-week, web-based nutrition education intervention (Mind Your Heart) on dietary behaviors and cardiometabolic health outcomes. The intervention is delivered via the University of Georgia e-Learning Commons (eLC) platform and incorporates evidence-based nutrition education and behavior change strategies.
Participants (UGA employees ≥18 years) are assigned to one of two virtual delivery approaches for the educational content. The intervention consists of six structured modules (approximately 20-30 minutes each), completed over a 6-week period.
Repeated measures are collected to assess behavioral and physiological change. Dietary behaviors and health habits are evaluated using validated self-report instruments administered via Qualtrics at baseline and post-intervention. To capture real-time eating behaviors, participants complete brief mobile-delivered questionnaires three times per week (two weekdays, one weekend day), totaling up to 18 assessments over the intervention period.
Objective health outcomes are assessed at baseline and follow-up laboratory visits and include cardiometabolic and nutritional biomarkers. Measures include venous blood sampling for lipid profiles, resting blood pressure, anthropometrics (height, weight, body composition), and ocular biomarkers (e.g., macular pigment optical density) as an index of nutrient status.
Dietary intake tracking is supported using a third-party application (MyFitnessPal), enabling complementary assessment of dietary patterns. Data are linked using unique study identifiers to ensure confidentiality. Integrated analyses will evaluate changes over time in behavioral and physiological outcomes and examine associations between intervention engagement, dietary behavior, and health indicators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years and older
- •Current University of Georgia (UGA) employees
- •Able to provide informed consent
- •Willing to complete online nutrition education modules over a 6-week period
- •Willing to attend in-person study visits for baseline and follow-up assessments
- •Willing to provide blood samples, blood pressure measurements, and complete eye exams
- •Willing to complete online and mobile-based questionnaires
- •Access to an internet-enabled device and a mobile phone for surveys and program
排除标准
- •Unable to complete study procedures, including online modules or in-person visits
- •Medical or other conditions that would preclude safe participation in study procedures (e.g., blood draw)
- •Lack of access to required technology (internet or mobile phone) for participation
结局指标
主要结局
Changes in Mindful Eating Behaviors
时间窗: 6 weeks
Change in mindful eating behaviors from baseline to 6 weeks was measured using the Mindful Eating Behavior Scale (MEBS), a 17-item self-report instrument assessing four domains of mindful eating. Focused Eating (5 items; mean score range 1-4) assesses attention to sensory aspects of food and the eating experience. Hunger and Satiety Cues (5 items; mean score range 1-4) assess awareness of and responsiveness to internal hunger and fullness signals. Eating with Awareness (3 items; mean score range 1-4) assesses conscious awareness of eating behaviors. Eating without Distraction (4 items; mean score range 1-4) assesses the ability to eat without engaging in competing activities or thoughts. Higher scores indicate greater mindful eating within each domain. A total MEBS score is not computed.
Change in DASH Diet Score
时间窗: Baseline to 6 weeks
Change in DASH diet adherence from baseline to 6 weeks was measured using the Dietary Approaches to Stop Hypertension (DASH) Diet Accordance Score. Dietary intake data were collected using MyFitnessPal and used to calculate adherence to nine DASH nutrient targets: total fat, saturated fat, protein, cholesterol, fiber, calcium, magnesium, sodium, and potassium. Each nutrient is scored as 0 (poor adherence), 0.5 (fair adherence), or 1 (compliant with the DASH target). Scores for all nine nutrients are summed to generate a total DASH Diet Accordance Score ranging from 0 to 9, with higher scores indicating greater adherence to DASH dietary recommendations and a more heart-healthy dietary pattern.
Change in Three Factor Eating Questionnaire
时间窗: 6 weeks
Change in eating behaviors from baseline to 6 weeks was measured using the Three-Factor Eating Questionnaire-Revised 18 (TFEQ-R18), an 18-item self-report instrument assessing three domains of eating behavior. Cognitive Restraint (6 items; mean score range 1-4) reflects the conscious restriction of food intake to control body weight or promote weight loss. Uncontrolled Eating (9 items; mean score range 1-4) reflects a tendency to overeat due to loss of control over food intake and responsiveness to hunger or food cues. Emotional Eating (3 items; mean score range 1-4) reflects the tendency to eat in response to negative emotions such as stress, anxiety, or sadness. Higher scores indicate greater levels of the respective eating behavior.
Changes in Motivation
时间窗: 6 weeks
Change in motivation for regulating eating behaviors from baseline to 6 weeks was measured using the Regulation of Eating Behaviors Scale (REBS), a 24-item self-report measure based on Self-Determination Theory. The REBS assesses six types of motivation: Intrinsic Motivation, Integrated Regulation, Identified Regulation, Introjected Regulation, External Regulation, and Amotivation. Items are rated on a 7-point scale. Autonomous motivation is calculated by summing Intrinsic, Integrated, and Identified Regulation subscales; controlled motivation is calculated by summing Introjected, External Regulation, and Amotivation subscales. Both scores range from 12 to 84, with higher scores indicating stronger motivation in the respective category. A self-determination score is calculated from weighted subscale scores, with higher values indicating greater autonomous motivation to regulate eating behaviors.
次要结局
- Change in Blood Pressure(Baseline to 6 weeks)
- Change Body weight(Baseline to 6 weeks)
- Change in BMI(6 weeks)
- Change in Waist Circumference(6 weeks)
- Change in Hip-to-Waist Ratio(6 weeks)
- Trait Mindfulness(6 weeks)
- Change in Ocular Nutrient Status(Baseline to 6 weeks)
- Changes in Perceived Stress(6 weeks)
- Change in Total Cholesterol(6 weeks)
- Change in Triglycerides(6 weeks)
- Low-Density Lipoprotein cholesterol (LDL-C)(6 weeks)
- High-Density Lipoprotein cholesterol (HDL-C)(6 weeks)
- Fasting Blood Glucose(6 weeks)
研究者
Anita Reina
Adjunct Professor
University of Georgia