Effect of Yoga on Psychological Wellbeing and Cell Survival Biomarkers Among Children and Adolescents with Type 1 Diabetes: An Open Label Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Effect of Yoga on psychological parameters i.e Depression, Diabetes Distress, Quality of life and Behavioral problems in children with Type 1 diabetes.
研究概览
简要总结
The global prevalence of Type 1 diabetes (T1D) in children and adolescents has been rising, with India reporting the highest numbers, as per the International Diabetes Federation (IDF). T1D contributes to chronic microvascular and macrovascular complications, in addition to psychological challenges, diminishing the quality of life for patients and their caregivers. Yoga, a holistic and inexpensive practice, could be an adjunct therapy to address these complications. There are very few studies on the benefits of Yoga for adolescents and children with T1D. There is no standardized T1D-specific Yoga module, insufficient long-term research, and limited focus on T1D population as compared to documented beneficial effects of Yoga among individuals with T2D. This is the first study to explore the effects of Yoga on psychological well-being and cellular health biomarkers among children and adolescents with T1D, along with their caregivers. The study aims to assess the impact of Yoga on psychological health, quality of life, and cellular biomarkers, and glycemic control in children and adolescents with T1D. An open-label, randomized controlled trial, with Yoga as intervention, will be conducted involving children and adolescents with T1D and their caregivers. Primary outcomes will include psychological health, while secondary measures encompass children’s cellular biomarkers, quality of life, HbA1c, and caregivers’ psychological well-being. A standardized, T1D-specific Yoga module, as a low-cost, accessible therapy, is expected to enhance psychological and biomolecular health, improve quality of life, foster glycemic control, and strengthen the parent-child bond, ultimately mitigating long-term complications of T1D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 8.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria for children and adolescents with T1D:
- •T1D diagnosed for at least 1 year.
- •Age- 8 to 18 years (inclusive ± 6 months)
- •Both genders.
- •Informed consent provided by the parent or the legal guardian, and assent by the children Inclusion criteria for caregivers of children and adolescents with T1D:
- •Age of caregiver 25- 45 years
- •The caregiver should be actively involved in the care of the child for at least 6 months and should be able to continue till the end of the intervention.
- •Accessibility of a smartphone to attend an online Yoga class.
排除标准
- •Exclusion criteria for children and adolescents with T1D:
- •Previously diagnosed intellectual disability, psychiatric disorders
- •Participants with chronic systemic illness, such as celiac disease, kidney, liver, or cardiovascular disease
- •Individuals having physical limitations which restrain them from performing Yoga
- •Already practising Yoga regularly
- •Individuals participating in any other trial
- •More than 1 child with T1D in the family Exclusion criteria for caregivers of children and adolescents with T1D:
- •Caregivers managing more than one child with T1D in the family
- •Pregnant mothers
- •Caregivers with any psychiatric illness
- •An individual with physical disabilities which restrain them from practising Yoga Intervention.
结局指标
主要结局
Effect of Yoga on psychological parameters i.e Depression, Diabetes Distress, Quality of life and Behavioral problems in children with Type 1 diabetes.
时间窗: 3 months interval for 1 year (Baseline, 3rd month, 6th month, 9th month, 12th month)
次要结局
- Effect of Yoga on cell survival biomarkers, and HbA1c, mean FBG and mean blood glucose in children and adolescents with T1D.
- Effect of Yoga on psychological well-being (Distress, Quality of life and burden) of caregivers.
研究者
Dr Rakesh Kumar
PGIMER, Chandigarh