跳至主要内容
临床试验/CTRI/2024/08/071905
CTRI/2024/08/071905尚未招募不适用

A Prospective study on the Efficacy of an integrated intensive lifestyle intervention program on management of obesity and associated comorbidities in Indian population

Freedom from diabetes research foundation1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年9月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
1) At least a 10% reduction in weight at one year and BMI drop below 23 or at least 3-point drop

研究概览

简要总结

The proposed study is a prospective, quasi-experimental, single-arm pre-post design that aims to assess the effect of an integrated intensive lifestyle intervention (ILI) in the management of obesity and associated comorbidities. The specific objectives of this study are 1) To assess the impact of an online intensive lifestyle intervention on weight loss, body mass index (BMI), and body composition (BC) parameters. 2) To assess the prevalence of comorbidities including prediabetes, T2D, dyslipidemia, hypertension, anxiety, depression, and stress. 3)To assess the effect of the intervention on improvements in comorbidities. 4)To assess the baseline characteristics of obese participants who attended an ILI-based management program. 5) To investigate the associations between clinical, anthropometric, biochemical, mental health, sleep quality, and physical activity outcomes in individuals with obesity. The targeted intervention will include dietary, exercise, psychological, and medical management. The mode of delivery of the intervention will be through online group sessions and individual counseling. The duration of the intervention will be one year. The data on sociodemographics will be collected at the time of enrollment. Data on anthropometric, body composition (measured by Karda scan and DXA),  biochemical parameters (e.g., Serum Lipids, Fasting, and post-prandial plasma glucose, creatinine/eGFR. LFT, RFT), and GPAQ (physical activity), will be collected at baseline and the end of the intervention (12 months). Meanwhile, data for the PHQ-9, GAD-7 (Depression and Anxiety), and PSQI (sleep quality index) scales will be collected at baseline and at the end of 6 months. To check the compliance adherence data will be collected from the patients.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
25.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Patients with Obesity (BMI 25 to 35 kg/m2, WHO Asia Pacific Guidelines) 2)Participants who are well-oriented in time, and space & as a person 3)Provide written informed consent 4)Physical and mental ability to take part in the study 5)No severe health issues and have not been hospitalized in the past six months 6)Agree to examinations as per the study protocol, undergo the lifestyle intervention program & post-program evaluation.

排除标准

  • Pregnant and lactating women were excluded from the study.

结局指标

主要结局

1) At least a 10% reduction in weight at one year and BMI drop below 23 or at least 3-point drop

时间窗: 1) Reduction in weight and BMI drop will be measured at baseline and at the end of the 12 months

次要结局

  • 1)Improvement in body composition (BC) parameters (fat percent, visceral fat percent, sub-cutaneous fat percent, skeletal muscle mass)(2)Improvement in Mental Health outcomes for Anxiety and Depression (in terms of reduction in scores below 10 for both anxiety and depression))

研究者

发起方
Freedom from diabetes research foundation
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Pramod Tripathi

Freedom From Diabetes Research Foundation

研究点 (1)

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