NCT07828717尚未招募不适用
Mindful Eating and Mindful Movement for Persons With Type 2 Diabetes Mellitus: A Pilot Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Feasibility of a combined mindful eating and yoga intervention
研究概览
简要总结
The proposed study is the first intervention of its kind and will add to the scientific literature in several important ways:
- The novel integration of Mindful Eating and Mindful Movement for T2DM: The MEMO trial is the first randomized controlled trial to test the feasibility and acceptability of a combined mindful eating and yoga intervention specifically tailored to adults with T2DM. This study directly addresses the growing prevalence of T2DM and the limitations of current lifestyle recommendations, which often lack strategies that promote sustainable behavior change. By integrating two complementary mindfulness-based components, the MEMO trial aims to holistically address dietary habits, physical activity, and stress management, providing a model for transformative, patient-centered diabetes care.
- Exploring Mindfulness in Diet and Exercise as a Driver of Behavior Change: By incorporating mindfulness into both dietary and physical activity interventions, this study seeks to address the psychological and behavioral barriers that often hinder long-term diabetes management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 years of age at study enrollment T2DM diagnosis for at least 6 months Baseline assessment HgbA1c between 7-12% Baseline assessment BMI ≥ 27 Physician's consent to participate in exercise program, if necessary Ambulatory Absence of health conditions that may be exacerbated by exercise No bariatric surgery within the past 5 years or plans for bariatric surgery within the next 6 months (self-reported) No diagnosis of advanced kidney disease (eGFR < 30, self-reported) No current cancer treatment (surgery/chemotherapy/radiation) (self-reported) Not pregnant, lactating, or plans to become pregnant during the 6-month study period (self-reported) No participation in a structured weight loss or diabetes study in the past 12 months Intention to remain in the Boston metropolitan area over the duration of the study Good or corrected hearing and vision (self-reported) Ability to participate in English Access to Zoom on phone, tablet, or computer No plan of starting a GLP-1 over the next 12 weeks
排除标准
- •Under 40 years of age Type 1 diabetes, gestational diabetes, or prediabetes diagnosis Baseline assessment HgbA1c < 7% or > 12% Baseline assessment BMI < 27 Non-consent of physician Non-ambulatory (e.g., use of walkers, wheelchairs) Presence of health conditions that may be exacerbated by exercise Bariatric surgery within the past 5 years or plans for bariatric surgery within the next 6 months Diagnosis of advanced kidney disease (eGFR < 30) Current cancer treatment (surgery/chemotherapy/radiation) (self-reported) Pregnant, lactating, or plans to become pregnant during the next 6 months Participation in a structured weight loss or diabetes study in the past 12 months Intent to move or take an extended vacation (> 2 weeks) during the first three months of the study period Problems with hearing or vision Inability to participate in English No access to Zoom on phone, tablet, or computer Started a GLP-1 in the past 3 months
研究组 & 干预措施
Standard of Care Diet and Exercise Group
Experimental
The standard of care diet program will provide participants with evidence-based dietary guidance aligned with current recommendations for T2DM and self-management tools, but no information regarding mindful eating or mindful meditation.
干预措施: Standard of Care Diet and Exercise Group (Behavioral)
Mindful Eating and Mindful Movement (MEMO) Group
Experimental
The mindful eating component of the MEMO intervention will receive the same protocol as the standard of care group but will also have mindfulness practices interwoven into the program.
干预措施: Mindful Eating and Mindful Movement (MEMO) Group (Behavioral)
结局指标
主要结局
Feasibility of a combined mindful eating and yoga intervention
时间窗: Primary endpoint: 12-weeks
Defined as achieving the target recruitment sample in a 12-month period, 80% retention, 70% attendance rate, and no serious adverse events.
Acceptability of a combined mindful eating and yoga intervention
时间窗: Primary endpoint: 12-weeks
Defined as \>5/7 on acceptability questionnaire (1 = unacceptable, 7 = very acceptable).
次要结局
- Mindfulness(Primary endpoint: 12-weeks)
- Physical Activity Using Accelerometry(Primary endpoint: 12-weeks)
- Dietary Habits(Primary endpoint: 12-weeks)
- BMI(Primary endpoint: 12-weeks)
- Hemoglobin A1c(Primary endpoint: 12-weeks)
- Cortisol(Primary endpoint: 12-weeks)
- Medication Adherence(Primary endpoint: 12-weeks)
- Medical History(Primary endpoint: 12-weeks)
- Self-Efficacy(Primary endpoint: 12-weeks)
- Subjective Physical Activity(Primary endpoint: 12-weeks)
- Perceived Stress(Primary endpoint: 12-weeks)
- Diabetes-Specific Stress(Primary endpoint: 12-weeks)
研究者
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