| CTRI Number |
CTRI/2026/04/107408 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
20/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
EX-Snack fit: A Digital Programs Impact on Weight, Fitness, and Confidence in Overweight and Obese Adults |
|
Scientific Title of Study
|
Development and Feasibility of the EX-SNACK-FIT Digital Intervention: A Pre-Post Analysis of Its Impact on Body Weight, Cardiorespiratory Endurance, and Self-Efficacy in Overweight and Obese Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Joshua Stanic Saldanha |
| Designation |
MPT Student |
| Affiliation |
Manipal College of Health professions |
| Address |
Department of physiotherapy, 2nd floor, Manipal College of Health professions, Manipal, Udupi Karnataka,576104
Udupi
KARNATAKA
576104
India |
| Phone |
8904553672 |
| Fax |
|
| Email |
joshua.mchpmpl2025@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mukesh Kumar Sinha |
| Designation |
Assistant Professor - Selection Grade |
| Affiliation |
Manipal College of Health professions |
| Address |
Department of physiotherapy, 2nd floor, Manipal College of Health professions, Manipal, Udupi, Karnataka,576104
Udupi
KARNATAKA
576104
India |
| Phone |
9535679047 |
| Fax |
|
| Email |
mukesh.sinha@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mukesh Kumar Sinha |
| Designation |
Assistant Professor - Selection Grade |
| Affiliation |
Manipal College of Health profession |
| Address |
Department of physiotherapy, 2nd floor, Manipal College of Health professions, Manipal, Udupi,Karnataka,576104
Udupi
KARNATAKA
576104
India |
| Phone |
9535679047 |
| Fax |
|
| Email |
mukesh.sinha@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy Manipal College of Health Professions, MAHE, Manipal District- Udupi State- Karnataka PIN- 57610 |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy, Manipal College of Health Professions |
| Address |
Department of physiotherapy, 2nd floor, Manipal College of Health professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka,576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Physiotherapy Manipal College of Health Professions |
Department of physiotherapy, 2nd floor, Manipal College of Health professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka,576104 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mukesh Kumar Sinha |
Kasturba Hospital |
Cardiopulmonary Fitness laboratory, 3rd floor, Manipal, Udupi, Karnataka,576104
Udupi
KARNATAKA |
9535679047
mukesh.sinha@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Medically stable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ex-Snackfit |
A simple digital program designed for users to encourage short, frequent physical activity in overweight or obese adults. There will be 2 Time points-baseline assessment and post-intervention assessment with the intervention duration of 8 Weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Individuals who read and speak English, BMI more than 25 kg/m², medically stable, Owns a smartphone/tablet with internet access |
|
| ExclusionCriteria |
| Details |
Diagnosed cardiovascular, neurological and musculoskeletal disease
Severe psychiatric/cognitive disorder
Pregnant or breastfeeding |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Feasibility-Recruitment rate, Retention rate, Adherence rate |
2 Time points-baseline assessment and post-intervention
assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Body weight, Cardiorespiratory endurance (VO2peak), and self-efficacy |
2 Time points-baseline assessment and post-intervention
assessment |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
15/04/2026 |
| 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="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
|
Brief Summary
|
Aim- To develop and evaluate the feasibility of a user centered Digital intervention EX-SNACK FIT for delivering short frequent bouts of physical activity exercise snacks and to analyze its impact on Body weight Cardiorespiratory endurance and Self Efficacy in Overweight and Obese Adults
Objectives
Primary Objective- To develop and evaluate the feasibility of the EX-SNACK FIT digital intervention in terms of recruitment retention and adherence rates among overweight and obese adults
Secondary Objectives- To assess the preliminary impact of the EX-SNACK FIT digital intervention on body weight Cardiorespiratory endurance VO2peak and self-efficacy related to physical activity in overweight and obese adults To gather qualitative feedback from participants regarding the acceptability and usability of the EX-SNACK FIT digital intervention
Procedure
The procedure will be carried out in two main steps In Step 1 the EX-SNACKFIT program will be developed by first conceptualizing it based on existing literature and qualitative insights from overweight obese individuals A prototype incorporating short simple exercise bouts will be created and reviewed by experts including physiotherapists and audiovisual professionals using PEMAT AV Based on their feedback necessary modifications will be made followed by further expert review and testing on a small sample The final version will then be prepared and submitted to the IEC
In Step 2 the intervention phase will begin with recruitment through social media advertisements and initial health screening of voluntary participants Eligibility will be confirmed using inclusion and exclusion criteria along with PAR Q followed by obtaining informed consent Baseline data including demographics anthropometry VO2peak and exercise self-efficacy will be collected The EX-SNACKFIT program will then be delivered via WhatsApp for 8 weeks with adherence monitored through reminders and polls Participants will visit the cardiopulmonary fitness laboratory twice once before the intervention Baseline assessment and one post intervention All data collection and analysis will be completed at the end of the 8 week period |