Ayurveda-inspired Diet and Lifestyle Intervention for Glycemic, Anthropometric, and Stress Improvements in Type 2 Diabetes: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in Health Habits Assessment Scale (HHAS) Score
研究概览
简要总结
This study looked at whether a 12-week Maharishi Ayurveda diet and lifestyle program was practical and acceptable for adults with Type 2 Diabetes. The program was offered through Family Health Centers in North Carolina and combined three parts: an Ayurvedic-based diet plan, guided yoga postures, and a breathing practice.
Seventeen participants started the program, and twelve completed the full 12- week intervention. The study focused on whether participants were able to follow the program regularly, complete study activities, and stay in the study for the full period. Participants were asked to practice the program at least five days per week and received regular support through scheduled and as-needed communication via phone, text messages, email, and video-based materials throughout the study.
The study also tracked changes in daily health habits, blood sugar levels, body weight, waist size, stress, and diabetes-related emotional well-being. Some information was collected using questionnaires, and some measurements were taken through clinic visits or home glucose monitoring.
Most participants who completed the program were able to follow the activities as instructed. Changes were observed in blood sugar levels, body weight, waist size, and measures of stress and diabetes-related distress. No serious safety concerns were reported.
Overall, the study showed that this Ayurvedic diet and lifestyle program could be safely carried out in a primary care setting. The results support further research with larger groups to better understand its potential benefits over time.
详细描述
Background and Rationale:
Type 2 Diabetes Mellitus (T2DM) is a chronic condition influenced by both genetic and modifiable lifestyle factors, including diet, physical inactivity, stress, and obesity. In the United States, diabetes prevalence has increased substantially over the past two decades, in part due to lifestyle-related factors. Although pharmacological therapies are widely used, long-term diabetes management remains challenging because of adherence difficulties, side effects, and psychosocial burden. Integrative lifestyle approaches that incorporate dietary regulation, physical activity, and stress-reduction practices may support diabetes self-management; however, their feasibility and acceptability within U.S. primary care settings require further evaluation.
Study Objective The primary objective of this study was to assess the feasibility, acceptability, and safety of a 12-week Maharishi Ayurveda-inspired diet and lifestyle program for adults with T2DM. The study aimed to evaluate participant adherence, program completion, and the practicality of implementing this multi-component intervention in a real-world primary care context.
Study Design This was a single-arm feasibility study conducted at Family Health Centers in North Carolina, USA. Adults with a diagnosis of T2DM were recruited from the clinic population. Seventeen participants initiated the intervention, and twelve completed the full 12-week program.
Intervention Overview
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 70 years
- •Diagnosed with Type 2 Diabetes Mellitus
- •Hemoglobin A1c between 6.5% and 9.5%
- •Receiving primary care at the Family Health Centers in North Carolina
- •Stable oral diabetes medication regimen for at least 3 months prior to enrollment
- •Able and willing to follow the study diet, yoga, and breathing practices
- •Able to communicate in English
- •Able to provide informed consent
排除标准
- •Diagnosis of Type 1 Diabetes
- •Current use of insulin
- •Recent changes in diabetes medications within the past 3 months
- •Pregnant or breastfeeding
- •Uncontrolled psychiatric illness that would interfere with participation
- •Physical limitations that prevent participation in yoga or movement practices
- •History of eating disorders
- •Allergy or strong aversion to foods used in the study diet
- •Participation in another lifestyle or intervention study during the study period
研究组 & 干预措施
Ayurveda Lifestyle Program
Participants in this single-arm feasibility study received a 12-week Maharishi Ayurveda-based lifestyle program that integrated dietary and lifestyle guidance, yoga-based physical activity, and breathing practices. All participants assigned to this arm received the same intervention and were followed for feasibility, adherence, and health-related outcomes.
干预措施: Maharishi Ayurveda Lifestyle Program (Behavioral)
结局指标
主要结局
Change in Health Habits Assessment Scale (HHAS) Score
时间窗: Baseline, 6 weeks, and 12 weeks
The HHAS is a self-report measure developed to assess participant engagement in health-promoting habits, including dietary choices, physical activity, daily routine, and stress-reduction practices. In this study, it was used to evaluate the feasibility and behavioral adherence to the Maharishi Ayurveda-based lifestyle program. Participants completed the HHAS at baseline, mid-, and post-intervention.
次要结局
- Change in Hemoglobin A1c (HbA1c)(Baseline and 12 weeks)
- Change in Fasting Blood Glucose (FBG)(Baseline, 2, 4, 6, 8, 10, and 12 weeks)
- Change in Body Weight (in lbs.)(Baseline and 12 weeks)
- Change in Body Waist Circumference (WC)(Baseline and 12 weeks)
- Change in Body Mass Index (BMI)(Baseline and 12 weeks)
研究者
Amandeep Negi
Doctoral Researcher
Maharishi International University