Effectiveness of Nurse-led Intensified Therapeutic Lifestyle Intervention Program (NITLIP) on Metabolic syndrome among adults working in food manufacturing and processing industries in Udupi District, Karnataka- A Cluster Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,091
- 试验地点
- 1
- 主要终点
- Improvement in clinical parameters, that includes waist circumference, blood pressure, HDL, triglycerides, fasting blood glucose level within normal standard range.
研究概览
简要总结
The objectives of the study are
Phase I
To identify Metabolic syndrome among the adults with central obesity working in selected food manufacturing and processing industries based on IDF criteria.
Phase II
To determine the health risk behavior and psychosocial risk factor
To assess the effectiveness of Nurse-led Intensified Therapeutic Lifestyle Intervention Program (NITLIP) on Metabolic syndrome among the subjects in experimental group as compared to control group at one month, three and six months.
Sampling technique
Phase I:
PPS sampling is used to derive the sampling of research participants in each taluk. The factories in each taluk will be randomly selected until the minimum requirement of participants from the factories per taluk are met.
Phase II:
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Factories with employees who are diagnosed having Metabolic syndrome during phase I will be considered as clusters for phase II study.
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The cluster should have a minimum of 5 participants (cluster size of 5). However, the cluster size will be estimated after completing the phase I study.
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Method of allocation sequence (Sequence generation) – the cluster will be randomly allocated with a 1:1 ratio in to intervention and control group by simple randomization technique using lottery method. Allocation concealment will be done at the cluster level by the third person (centralized) who is not involved in the study which is to avoid the allocation bias
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Random start will be done by using the third party to avoid selection bias.
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The investigator will be implementing the NITLIP to the intervention group after obtaining the baseline data, 1 & 3 months and control group receives no intervention however they will continue to receive the standard care during the study period. Hence, the blinding of study investigators and participants is not possible for this study.
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The follow-up data will be collected at 1,3,and 6 months
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Contamination: assessment of contamination will be done at the end of the last follow-up if necessary.
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The control group will receive the NITLIP after obtaining the data for the last follow-up.
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Detailed description of procedure / processes: Phase I: The data for phase I will be collected after obtaining ethical clearance. Formal administrative permission will be obtained from the factory owners. After obtaining informed consent, demographic data and health risk behavior will be collected using a predetermined tool and the study participants height, weight, waist circumference and blood pressure will be obtained. The research participants falling in the criteria for IDF (2005), males waist circumference > 90 and females waist circumference >80 is considered for invasive test.
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Written informed consent will be obtained from the employees working in food manufacturing and processing units at Udupi district who are at potential risk for metabolic syndrome to perform the invasive test. Once the written consent is obtained the researcher will carry out the invasive test which will confirm the diagnosis of metabolic syndrome. The participants are educated to provide the fasting blood on the date mentioned by the researcher. The study utilizes IDF criteria for the diagnosis of metabolic syndrome. According to this, Central obesity is the major criteria for diagnosing metabolic syndrome. Hence the lipid profile along with fasting blood glucose will be assessed for only those participants identified with central obesity and diagnosis of the metabolic syndrome will be made accordingly.
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The researcher will take fasting blood samples of the selected research participants. Based on the IDF criteria the diagnosis of metabolic syndrome will be established
Phase II:
For the intervention aspect of the study, factories with employees with diagnosis of Metabolic syndrome is considered as clusters. The researcher will randomize the clusters into intervention and control group. Standard care will be recommended for all established Metabolic syndrome diagnosed cases and adherence to the same will be assessed via self-reporting.
Data collection
Written informed consent will be obtained. Demographic data, data on psychosocial risk factors and health risk behavior will be obtained.
Data collection for experimental group
The research participants assigned to the experimental group will receive NITLIP for 4 days. The participants in the experimental group will be assigned to a group of 8 members in a factory if there are large numbers of research participants. The research participants will be informed to continue yoga asanas at home and enter in the log provided in the information guide.
Telephone calls will be made. Follow up will be done at one month and 3 months (only BP assessment, waist circumference and motivating to continue intervention) and at 6 months to observe the baseline changes in the IDF specific criteria, health risk behavior and psychosocial risk factors. Changes from the baseline data will be monitored to see the efficacy of the intervention. During the follow up period at one and three months, the research participants will be made to demonstrate yoga and will be re-sensitized on importance of the intervention.
Data collection for control group
Control group will not receive any intervention. Follow up will be done at one month and 3 months (only BP assessment, waist circumference and at 6 months to observe the baseline changes in the IDF specific markers, psychosocial risk factors and health risk behaviors.
The participants assigned to the control group will receive NITLIP after the data collection of intervention group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Phase I Adults aged 35-55 years, Working more than 6 months in the food manufacturing and processing industry who are willing to participate in the study and can read or write Kannada or English language Phase II Participants diagnosed with metabolic syndrome in Phase I.
排除标准
- •Phase I Adults aged 35 to 55 years with Physical activity limitations like fracture, osteoporosis, pain in joints and muscles, the ones who are diagnosed with psychiatric illness, stroke, cancer, kidney diseases, cardiac diseases and pregnant women will be excluded.
- •Phase II The research participants with blood pressure more than 220 mmHg systolic and 120 mmHg diastolic and fasting blood glucose level more than 200 mg per dl will be excluded from the study.
结局指标
主要结局
Improvement in clinical parameters, that includes waist circumference, blood pressure, HDL, triglycerides, fasting blood glucose level within normal standard range.
时间窗: Measured at 6 months of the intervention
次要结局
- Mean difference in health risk behaviour and psychosocial risk factor scores(Measured at 6 months of intervention)
研究者
Reshma R Kotian
MAHE, Manipal