Evaluation of integrated intensive wellness strategy on biophysiological parameters,life style practices and quality of life among adults with Type 2 diabetes mellitus with hypertriglyceridemia - A randomized controlled trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Statistically significant reduction of mean of
研究概览
简要总结
1. Research Questions
Does integrated intensive wellness strategy have an effect on biophysiological parameters, lifestyle practices and quality of life among Type 2 diabetes mellitus adults with hypertriglyceridemia?
2. Objectives
Primary objectives
- To evaluate the efficacy of Integrated Intensive Wellness Strategy compared with the Control arm on HbA1c from baseline to week 24 among Type 2 diabetes mellitus adults with hypertriglyceridemia at selected urban health and wellness centre in Puducherry.
Secondary objectives
-
To evaluate the efficacy of Integrated Intensive Wellness Strategy compared with the Control arm on other Biophysiological parameters, Lifestyle practices and Quality of Life from baseline to week 4, 12 and 24 among Type 2 diabetes mellitus adults with hypertriglyceridemia.
-
To associate the post-interventional Clinical parameters with QOL and lifestyle practices in IIW Strategy arm.
3. Description of study arm
A. Intervention arm: Integrated Intensive Wellness Strategy (IIW)
IIW Strategy refers to Comprehensive Lifestyle Modification therapy such as BCC, AGC juice, Walking program and Alternate Nostril
Breathing Exercise.
B. Control arm: Oral antidiabetics
4. Study variables
Socio demographic variables Age in years, gender, education, occupation, type of family, annual income of the family, health insurance facility, finance for the treatment ,use of alternative medicines.
Clinical variables Duration of treatment, duration of T2DM, Blood pressure, co-morbidities, number and class of anti-diabetics and anti-hypertensives.
Outcome variable HbA1C, FBS, Triglycerides, SBP, DBP, Weight, BMI &Waist-Circumferance.
Scale on life style practices Eating vegetables, eating fruits, sprinkle salt on food, eating pickle, eating deep fried food/snacks, type of diet, smoke/chew tobacco, drink alcohol, sleep and practice of regular
exercises adopted by WHO steps questionnaire and Food frequency questionnaire.
WHOQOL-BREF questionnaire for HRQOL domain
5. Data collection and measurements:
Formal permission will be obtained from the Directorate of Health and Family welfare(Director Public health and Directorate- ISM),Government of Puducherry for conducting study at UHWC, Muthialpet & Kalapet.
For processing biochemical samples formal permission will be obtained from Director-Principal and Laboratory Head, PIMS.
Data will be collected by Epi collect 5 Android mobile phone based free application for the following details
a. Socio-demographic variables such as age in years, gender, education, occupation, type of family, annual income of the family, health insurance facility, finance for the treatment and use of alternative medicine etc.
b. Behavioural measures such as Tobacco use, Alcohol use, Physical activity, Sedentary behavior and Diet pattern.
c. Medical history such as CVD, diabetes related medications and any other comorbidity etc.,
d. Updated family history of disease
Following Instruments will be used for the biophysiological measurements in this study
Cobas integra 400+ fully automated clinical chemistry analyzer for biochemical parameter
Digital electronic blood pressure apparatus for B.P.
Mechanical Weighing machine
Inch tape for mreasuring height
6. Study variables
Socio demographic variables Age in years, gender, education, occupation, type of family, annual income of the family, health insurance facility, finance for the treatment ,use of alternative medicines.
Clinical variables Duration of treatment, duration of T2DM, Blood pressure, co-morbidities, number and class of anti-diabetics and anti-hypertensives.
Outcome variable HbA1C, FBS, Triglycerides, SBP, DBP, Weight, BMI & Waist-Circumferance.
Scale on life style practices Eating vegetables, eating fruits, sprinkle salt on food, eating pickle, eating deep fried food/snacks, type of diet,
smoke/chew tobacco, drink alcohol, sleep and practice of regular exercises adopted by WHO steps questionnaire and Food frequency questionnaire.
WHOQOL-BREF questionnaire for HRQOL domain
7. Scope of the study
This study will helps to promote healthy wellbeing and improve HRQoL at affordable range among diabetics which will create an greater impact to the Individual, Society and Government in view of reducing the burden
of disease in healthy way.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •All registered Type 2 DM 30 to 65 years with the FBS greater than 125mg/dl, HbA1C greater than 6.5 and Triglycerides greater than 130mg/dl to lesser than 250 mg/dl will be included in the study
- •A signed and dated written informed consent prior to admission to the study.
排除标准
- •1.History of any co-morbidities other than hypertension.
- •2.History of patient on Insulin treatment.
- •3.Newly registered patient less than one month 4.History of any Amla, ginger and curry leaves allergy.
- •5.History of Anatomical deformities in Nasal pathway and Extremities.
结局指标
主要结局
Statistically significant reduction of mean of
时间窗: Six months
HbA1c from baseline to weeks 24 and FBS,TGL,SBP, DBP, Weight, BMI, Waist Circumferance from baseline to week 4, 8,12 and week 24 at p value less than 0.05 level in
时间窗: Six months
IIW Strategy than control arm.
时间窗: Six months
次要结局
- Statistiscally significant improvement in Lifestyle(practices and Quality of life at p value less than 0.05 level in IIW Strategy than Control arm.)
研究者
DrRadhika R
Pondicherry Institute of Medical Sciences