Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, India.
Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, India
BMJ Open. 2021 Mar 22;11(3):e044895. doi: 10.1136/bmjopen-2020-044895.
There has been a steep increase in the prevalence of adolescent overweight and obesity globally and in India, demonstrating that present prevention strategies are insufficient. Available evidence suggests that multifactorial interventions may improve short-term physical activity (PA), nutrition and psychological behaviour of overweight and obese adolescents but long-term follow-ups and strategies are needed. This study will investigate the effects of a structured multifactorial (school-based and family-based) intervention on adolescent obesity, compared with a single or no intervention.
A pragmatic, clustered randomised controlled trial with 12 weeks of interventions and 3-month, 6-month and 12-month follow-ups will be conducted at multiple participating schools in Karnataka, India. The participants will be overweight and obese male and female adolescents aged 11-16 years and will be randomly assigned by school into three groups: group A (multifactorial intervention, exercise and dietary advice); group B (exercise only); and group C (controls, no interventions). Primary outcome measures are the level of PA and body composition. Secondary outcomes are dietary change, behaviour change, food behaviours, cardiovascular and muscular fitness, quality of life, parental behaviours (physical and mental) and family functioning. Positive intervention results may reduce obesity in adolescents and promote a healthier lifestyle for students and families. A larger, culturally diverse population can benefit from a similar methodology.
The study has been approved by the Institutional Research and Ethics Committee (IEC 536-2018), Kasturba Hospital, Manipal, Udupi District, Karnataka, India. A written and verbal informed consent (supplemental material) will be provided to the participants prior to participation. On completion of the trial, the results can be communicated to adolescents and their parents on request, and will be published at national and international conferences and in peer-reviewed journals.
CTRI/2019/04/018834.
全球和印度青少年超重和肥胖的患病率急剧上升，这表明目前的预防策略还不够。现有证据表明，多种因素干预可能改善超重和肥胖青少年的短期身体活动（PA）、营养和心理行为，但需要长期随访和策略。本研究将调查结构化多因素（基于学校和基于家庭）干预对青少年肥胖的影响，与单一干预或无干预进行比较。
这是一项在印度卡纳塔克邦多个参与学校进行的实用、聚类随机对照试验，干预时间为 12 周，随访时间为 3 个月、6 个月和 12 个月。参与者为超重和肥胖的 11-16 岁男女生青少年，将按学校随机分为三组：A 组（多因素干预，运动和饮食建议）；B 组（仅运动）；和 C 组（对照组，无干预）。主要结局指标为 PA 水平和身体成分。次要结局指标为饮食变化、行为变化、食物行为、心血管和肌肉健康、生活质量、父母行为（身体和心理）和家庭功能。积极的干预结果可能会降低青少年的肥胖率，并为学生和家庭促进更健康的生活方式。更大、文化更多样化的人群可以从类似的方法中受益。
该研究已获得印度卡纳塔克邦 Manipal 的 Kasturba 医院机构研究和伦理委员会（IEC 536-2018）的批准。在参与之前，将向参与者提供书面和口头知情同意书（补充材料）。试验完成后，可应要求向青少年及其家长传达结果，并在国家和国际会议及同行评议期刊上发表。
CTRI/2019/04/018834。
