| CTRI Number |
CTRI/2025/03/083087 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of selected Integrated physical activity and habit modification on selected physiological, psychosocial and academic aspects in adolescents with and with risk of Metabolic syndrome. |
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Scientific Title of Study
|
Assess effect of selected nursing interventions (Integrated physical activity and habit modification ) on selected physiological parameters ,psychosocial aspects and academic stress in adolescents with and with risk of metabolic syndrome in selected schools |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chhameshwari Verma |
| Designation |
P.hD Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (DU) Sawangi(Meghe), Wardha, Maharashtra |
| Address |
Room no 7,Srimati Radhikabai Meghe Memorial College of Nursing (SRMMCON), Datta Meghe Institute of Higher Education and Research (DU) Sawangi(Meghe), Wardha, Maharashtra
Wardha
MAHARASHTRA
442004
India |
| Phone |
7389135846 |
| Fax |
07152-287719 |
| Email |
chhaya8385@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Archana Maurya |
| Designation |
Professor Dept Of Pediatrics SRMMCON |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (DU) Sawangi(Meghe), Wardha, Maharashtra |
| Address |
Room no 03,Dept Of Pediatrics, Srimati Radhikabai Meghe Memorial College of Nursing (SRMMCON), Datta Meghe Institute of Higher Education and Research (DU) Sawangi(Meghe), Wardha, Maharashtra
Wardha
MAHARASHTRA
442004
India |
| Phone |
9422903004 |
| Fax |
07152-287719 |
| Email |
archanatej95@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chhameshwari Verma |
| Designation |
P.hD Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (DU) Sawangi(Meghe), Wardha, Maharashtra |
| Address |
Room no 7,Srimati Radhikabai Meghe Memorial College of Nursing (SRMMCON), Datta Meghe Institute of Higher Education and Research (DU) Sawangi(Meghe), Wardha, Maharashtra
Wardha
MAHARASHTRA
442004
India |
| Phone |
7389135846 |
| Fax |
07152-287719 |
| Email |
chhaya8385@gmail.com |
|
|
Source of Monetary or Material Support
|
| Monetary support by self and infrastructural support by Srimati Radhikabai Meghe Memorial College of Nursing (SRMMCON), Datta Meghe Institute of Higher Education and Research (DU) Sawangi(Meghe), Wardha, Maharashtra
|
|
|
Primary Sponsor
|
| Name |
Chhameshwari Verma |
| Address |
Room no 07,Srimati Radhikabai Meghe Memorial College of Nursing (SRMMCON), Datta Meghe Institute of Higher Education and Research (DU) Sawangi(Meghe), Wardha, Maharashtra
|
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mrs Chhameshwari Verma |
Jila Parishad School |
NH-204 Wardha Yavatmal Road Salod Wardha
Wardha
MAHARASHTRA |
7389135846
07152-287719
chhaya8385@gmail.com |
| Mrs Chhameshwari Verma |
Nehru Vidyalaya |
Salod Hirapur Wardha
Wardha
MAHARASHTRA |
7389135846
07152-287719
chhaya8385@gmail.com |
| Mrs Chhameshwari Verma |
Sant Chavara School |
Opposite Neri Punarvasan Salod Hirapur Wardha
Wardha
MAHARASHTRA |
7389135846
07152-287719
chhaya8385@gmail.com |
| Mrs Chhameshwari Verma |
School of Scholars |
Paloti Wardha road Near Sub station Sawangi Wardha
Wardha
MAHARASHTRA |
7389135846
07152-287719
chhaya8385@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research Sawangi (Meghe) Wardha, Maharashtra |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Obesity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Excluding Surya Namaskar from integrated physical activity; Bicycle riding will be given. Habit modification (diet ,Sleeping hour limitation and Screen time limitation)will be done |
The study for the Comparator (Control) Group follows a similar structure to the Interventional Group excluding Surya namaskar with three phases:
Phase I: Preparatory Phase
• Initial screening for identifying obese and overweight adolescents based on Waist circumference, Height, Weight, and BMI.
• Obtain Informed Assent from Control group participants & consent from their parents.
Phase II: Intervention Phase
• Part 1 - Pre-test: Assess physiological parameters (Blood pressure, Sr. glucose); psychosocial aspects and Academic stress using standardized tools respectively Y-PSC (Youth Pediatric symptom checklist), Modified scale for assessing academic stress( SAAS).
• Part 2 - Intervention:
• Integrated physical activity includes ONLY BICYCLE RIDING for the Control group. Surya namaskar excluded.
• Bicycle riding: 15 min. moderate intensity riding @ 10-12 km/h for 3 km in the morning, five days a week for 3 months.
• Habit Modification involves dietary, screen time (less than 2 hours per day), and sleeping time regulation(7 to 8 hours per day) for 3 months, similar to the Interventional Group.
• Dietary interventions categorized into three groups based on food items.
• Recommendations follow recent Endocrine Society guidelines.
Phase III: Evaluation Phase
• Part 1 - Mid Evaluation Phase: Assess physiological parameters, psychosocial aspects, and academic stress at 1.5 months.
• Part 2 - Final Evaluation Phase: Assess parameters again at 3 months, comparing baseline, mid, and final evaluations.
• Comparison of Experimental and Control groups to determine the interventions effects on physiological parameters, psychosocial aspects, and academic stress.
|
| Intervention |
Integrated physical activity (Bicycle riding and Surya Namaskaar ) and habit modification (diet ,Sleeping hour limitation and Screen time limitation) |
The study for the Intervention (Experimental) Group includes Integrated physical activity( Bicyle riding and Surya namaskar) and Habit Modification with three phases:
Phase I: Preparatory Phase
• Initial screening for identifying obese and overweight adolescents based on Waist circumference, Height, Weight, and BMI.
• Obtain Informed Assent from Experimental group participants & consent from their parents.
Phase II: Intervention Phase
• Part 1 - Pre-test:
 Physiological parameters: Blood pressure and fasting glucose level.
 Psychosocial evaluation using the standardized tool Y-PSC (Youth Pediatric Symptom Checklist) comprising 35 questions with scores ranging from 0 to 2. Score 30 indicates Psychosocial disturbance.
 Academic stress assessment with Modified Scale for Assessing Academic Stress (SAAS): 30-item self-report tool with “Yes†or “No†answers, with score 30 indicating highest stress level on a 4-point Likert scale.
• Part 2 - Intervention:
I. Integrated physical activity includes Bicyle riding and Surya namaskar & Guided by trainers
A. Bicycle riding: 15 min. moderate intensity riding @ 10-12 km/h for 3 km in the morning, five days a week for 3 months.
B. Surya Namaskar:
 Follows cycling.
 Daily: 5, 7, 9, and 12 sets progressively for 20 min. in the morning
 Instructions:
 Empty stomach; honey if weak.
 No shower, food, or water for 30 mins post-practice.
 Empty bladder/bowels.
 Start with a prayer.
 Perform with body awareness.
 Warm-up included.
 Stay hydrated; wear comfy clothes.
 Use a grippy mat.
 Focus on nasal breathing.
 Avoid holding breath unnecessarily.
 Perform within limits; regular practice crucial.
 End with silence.
II.Habit Modification involves dietary, screen time (less than 2 hours per day), and sleeping time regulation(7 to 8 hours per day) for 3 month.
 Dietary interventions categorized into three groups based on food items.
Group 1 (To be eaten freely)- Pulses, yellow vegetables, green leafy vegetables, fruits, protein-containing foods, poultry, lean meats .
Group 2 (To be eaten judiciously) – cereals, dairy foods with low fat, animal fat,
Group 3 (To be eaten rarely)- Oily foods, sugar added foods, calorie dense foods .
 Dietary Recommendations follow recent Endocrine Society guidelines.
Phase III: Evaluation Phase
• Part 1 - Mid Evaluation Phase: Assess physiological parameters, psychosocial aspects, and academic stress at 1.5 months.
• Part 2 - Final Evaluation Phase: Assess parameters again at 3 months, comparing baseline, mid, and final evaluations.
 Comparison of Experimental and Control groups to determine the interventions effects on physiological parameters, psychosocial aspects, and academic stress.
|
|
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Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Adolescents with age group of 11 to 16 years Who are overweight or obese
2. Those who are willing to participate in the study with the consent of parents.
3. Those who can read or write and understand Hindi or English or Marathi.
4.Those who all are available at the time of data collection.
|
|
| ExclusionCriteria |
| Details |
1.Adolescents whose parents are not willing that their wards will participate in study.
2. Adolescents with any type of chronic illness.
3. Adolescents who are not able to participate for continuous 5 days in intervention due to iliness.
|
|
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Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be positive efficacy of Selected Interventions ( Integrated Physical Activity And Habit Modification) after 3 months of intervention on selected physiological parameters and academic stress in adolescents with risk of metabolic syndrome on experimental group. |
Initial, 1.5 month, 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There will be positive efficacy of Selected Interventions ( Integrated Physical Activity And Habit Modification) after 3 months of intervention on selected psychosocial aspects in adolescents with risk of metabolic syndrome on experimental group. |
Initial, 1.5 month, 3 month |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
WHO stated more than 1 billion people worldwide are obese – 650 million adults, 340 million adolescents and 39 million children(aged 5-19 yrs) .WHO estimates that by 2025, approximately 167 million people – adults and children – will become less healthy due to this.With 14.4 million obese children, India has the second-highest number of obese children in the world, next to china. The prevalence of overweight and obesity in children in India is 15%. Global
Prevalence of metabolic syndrome is 0-19.2% in children and adolescents
and 20-25% in adults according to the IDF in 2021. Prevalence of pediatric
(8-19 yrs) metabolic syndrome in India is 21.8 % as per recent study of 2019 . In different parts
of the country it is in the range of 1.5%–9.9%. (2018, Shimla, Himachal
Pradesh, Central India) In one study at Wardha it
is 9.9% (2008)
Based on the findings of study the researcher intend to develop an integrated physical activity and habit modification intervention so the children will be prevented from various cardiovascular, metabolic and other associated disorders. After successfully completion of this study ,it will be communicated to the ministry to incorporate these interventional program in school’s curriculum so every child will get benefit of it. These are collaborative activities between parents and school so with these mutual understanding and efforts, goal of healthy nation can be achieved. It will help parents, teachers and school health Nurse to reduce the Academic stress and promote enriched psychosocial well being at the grass root level .It will also aid in reducing various mental illnesses that results from psychosocial imbalance and Academic stress and also promote enrichment of Psychosocial aspects In this era of busy life , luxuries , and communicable diseases this can be a helpful tool for prevention of emerging non communicable diseases. As Integrated physical activity is combination of Indian ancient Surya namaskaar along with cycling and Habit modification ; it is more efficacious approach as compared to single modality.
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