Effect of Tailored Nursing Intervention on Participants Suffering from Metabolic Syndrome in The Selected Rural Areas of Anand District Of Gujarat State: A Randomized Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Significant change in biological parameter of metabolic syndrome
研究概览
简要总结
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problem statement:- “Effect of Tailored Nursing Intervention on Participants Suffering from Metabolic Syndrome in the Selected Rural Areas of Anand District of Gujarat State: A Randomized Control Trial.”Institutional Permissions: Approval from the Head of Manikaka Topawala Institute of Nursing will be obtained.
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Ethical Clearance: Ethical approval secured from the institutional ethics committee, and further ethical permission also obtained from the concerned PHC and CHC of Anand District.
Study Design and Participant Allocation
- In this phase participants will be recruited using a block randomization procedure, based on the prevalence rate determined in Phase I.
- A single-blinding technique will be employed, where participants will be randomly assigned to either the experimental group or the control group.
- Allocation Concealment:
- Participants will be selected from the study setting and randomly allocated to the experimental or control group using computer-generated block randomization.
- The experimental group will receive a nurse-tailored intervention, while the control group will receive the nurse talored intervention after the completion of data collection.
Nurse tailored intervention
- Informed Consent: The researcher will introduce himself to participants during home visits, explain the study’s purpose, and obtain written informed consent.
- Nurse-Tailored Intervention (28 Days) for the Experimental Group:
- Individualized Health Education:
- Face-to-face health teaching sessions during home visits.
- Dietary Modifications:
- A metabolic diet plan chart will be provided to participants.
- Physical Activity Component:
- Encouragement of 30-minute morning and evening walks.
- Participants will receive text message reminders in the morning and evening.
- Follow-Up and Support:
- The researcher will monitor participants’ diet and exercise adherence via telephonic follow-ups (twice a month).
- Self-Monitoring:
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Each participant will maintain a self-diary to track their diet, exercise, and adherence throughout the intervention period.
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Health teaching on metabolic syndrome.
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Metabolic Diet .
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physical activity.
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followup and support
Post-Intervention Assessment
- After the 28-day intervention period, a post-test evaluation will be conducted to assess the effectiveness of the nurse-tailored intervention.
- The researcher will express gratitude to all participants for their involvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants who meet at least three out of five high-risk metabolic criteria including Elevated Fasting Plasma Glucose Central Obesity Elevated Triglycerides Reduced High-Density Lipoprotein (HDL)Elevated Blood Pressure Participants who are available at the time of the study.
排除标准
- •Those participants having physical deformity.
结局指标
主要结局
Significant change in biological parameter of metabolic syndrome
时间窗: Time point is a specific time at which outcome will be assessed after 8 weeks only
1. Waist Circumference.
时间窗: Time point is a specific time at which outcome will be assessed after 8 weeks only
2. Fasting blood sugar.
时间窗: Time point is a specific time at which outcome will be assessed after 8 weeks only
3. Blood Pressure.
时间窗: Time point is a specific time at which outcome will be assessed after 8 weeks only
4. HDL
时间窗: Time point is a specific time at which outcome will be assessed after 8 weeks only
5. LDL
时间窗: Time point is a specific time at which outcome will be assessed after 8 weeks only
次要结局
- "Improvement in knowledge and self-care practices related to metabolic syndrome management."
研究者
Chirag Jain
Maniakaka Topawala Institute of Nursing