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临床试验/CTRI/2021/12/038785
CTRI/2021/12/038785已完成不适用

Effectiveness of nurse-led intervention on weight reduction among adults with obesity in urban areas of Puducherry–An exploratory sequential mixed method.

JIPMER Intra Mural Research Fund1 个研究点 分布在 1 个国家目标入组 438 人开始时间: 2022年1月6日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
438
试验地点
1
主要终点
Clinically significant reduction in body weight ≥ 5% from baseline weight among intervention group compared with general care group.

研究概览

简要总结

This is randomized trial to evaluate the effectiveness of  nurse-led intervention on weight reduction among adults with obesity in urban areas of Puducherry. 

Report of the Pilot Study:

The recent increase in type 2 diabetes is likely due to the rising prevalence of overweight and obesity, which heightens the risk of non-communicable diseases. This study aimed to evaluate the effectiveness of nurse-led intervention (NLI) strategies on weight reduction among adults in urban Puducherry. A two-arm, parallel-group, randomized controlled study was conducted with 88 obese adults from Nesavalar colony and Govindanpet between November 2022 and February 2023. Participants were randomized into either the NLI or general care (GC) arm. Interviews were conducted to gather demographic and behavioral risk factor data, and physical and biochemical measurements were taken following standardized procedures. Villages were randomly assigned to either the intervention or control group using Excel. The NLI group received nurse-led interventions, including Surya Namaskar yoga, while the GC group received standard care. At 16 weeks, the NLI arm showed a significant mean weight loss of -2.58 kg, compared to a 0.38 kg gain in the GC arm, with improvements in waist circumference, body mass index, cholesterol profile, and thyroid-stimulating hormone levels. The study demonstrated that nurse-led interventions effectively reduced weight and the risk of non-communicable diseases in urban Puducherry, though a more extensive follow-up plan and additional manpower will be necessary for larger studies.

Summary of the Main Study:

Participants were interviewed to gather demographic information and assess behavioral risk factors, including diet and physical activity. Physical measurements such as height, weight, waist circumference, and blood pressure were taken following standardized procedures. Biochemical measurements involved blood sample collection after overnight fasting to analyze fasting blood glucose, total cholesterol, and thyroid profile. Villages were randomly assigned to either the intervention or control group using Excel, ensuring equal distribution. No allocation concealment was used since the intervention was applied simultaneously across villages, reducing selection bias. Blinding was not implemented due to the primary investigator’s involvement in both intervention delivery and baseline assessments; however, outcome assessments were conducted by independent nurses who were blinded to group assignments. The intervention group received nurse-led interventions, including sessions on Surya Namaskar (Sun Salutation) yoga, while the control group received standard care. After 12 months, participants’ weight reduction was reassessed and compared with baseline data, and health workers in the control group were subsequently educated using the nurse-led intervention package. COVID-19 precautions were implemented to prevent transmission, particularly in containment zones.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Adults with obesity, aged between 18-50 yrs, all gender,who can speak and write Tamil or English,who access to phone.

排除标准

  • Adults with limitations for physical activities (physical disability and bed ridden), with medications and diseases, which can affect weight loss, currently on weight loss program, bariatric surgery and pregnant, visual and hearing impairments.
  • •Psychiatric disorders.

结局指标

主要结局

Clinically significant reduction in body weight ≥ 5% from baseline weight among intervention group compared with general care group.

时间窗: Baseline assessment- at 1st month | Midline assessment-at 6th month | Endline assessment-at 12th month

次要结局

  • Proportion of beneficial effect among nurse-led intervention group(1.Reduction in absolute weight.)

研究者

发起方
JIPMER Intra Mural Research Fund
申办方类型
Research institution and hospital

研究点 (1)

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