| CTRI Number |
CTRI/2022/02/040202 [Registered on: 10/02/2022] Trial Registered Prospectively |
| Last Modified On: |
30/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Physiotherapy (Not Including YOGA)
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
smartphone application-based physical activity promotion in overweight and obese young adult |
|
Scientific Title of Study
|
Influence of smartphone application based physical activity promotion on body mass, waist circumference, blood pressure and executive function in overweight and obese young adults: Pilot Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sapna Vithoba Domal |
| Designation |
Postgraduate |
| Affiliation |
Manipal academy of higher education |
| Address |
Department of Exercise and Sports Sciences, MCHP, Manipal
Department of Exercise and Sports Sciences, MCHP, Manipal
Udupi
KARNATAKA
641004
India |
| Phone |
8805744812 |
| Fax |
|
| Email |
sapnadomalg4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Baskaran Chandrasekaran |
| Designation |
Assistant professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Exercise and Sports Sciences, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka
Udupi
KARNATAKA
641004
India |
| Phone |
07639280751 |
| Fax |
|
| Email |
baskaran.c@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Baskaran Chandrasekaran |
| Designation |
Assistant professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Exercise and Sports Sciences, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
641004
India |
| Phone |
7639280751 |
| Fax |
|
| Email |
baskaran.c@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
manipal academy of higher education |
| Address |
manipal academy of higher education |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Baskaran Chandrasekaran |
Manipal College of Health Professions |
1, Ground floor, Center for Exercise and Sports Sciences, Marena, MAHE, Manipal
Udupi
KARNATAKA |
7639280751
baskaran.c@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Overweight and Obese individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Education only group |
The participants will receive only education regarding physical activity promotion |
| Intervention |
Smartphone application based physical activity |
m-health based physical activity for 8 weeks. The app gives a goal setting for next 8 weeks based on the step count |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
34.00 Year(s) |
| Gender |
Both |
| Details |
Overweight and obese
The intervention group should have an android based smartphone |
|
| ExclusionCriteria |
| Details |
Chronic conditions that affect physical and mental health
Acute trauma affecting the physical activity participation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Body mass index
|
0 and 8th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Waist circumference |
0th and 8th week |
| Blood pressure |
0th and 8th week |
| executive functions |
0th and 8th week |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/03/2022 |
| Date of Study Completion (India) |
27/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
27/04/2022 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Our pilot trial examined the effects of smartphone-based personalised participatory physical activity approach on weight loss measures and cognitive functions in obese adults. Though we did not observe any significant change in the weight loss measures such as fat %, BMI or the blood pressure, the executive functions found to be improved by 8-12% after 8 weeks of the physical activity program. |