| CTRI Number |
CTRI/2022/10/046246 [Registered on: 07/10/2022] Trial Registered Prospectively |
| Last Modified On: |
06/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutritional Counselling] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
“Effectiveness of dietary intervention on health of children with cystic fibrosis, and development of an App on Cystic Fibrosis Self- Management (CFSM)†|
|
Scientific Title of Study
|
“A Pilot testing of a nutritional intervention package (NIP) on children with cystic fibrosis, and development of an App on Cystic Fibrosis Self- Management (CFSM)†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rimple Sharma |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No 4,College of Nursing, Old OT Block, AIIMS, New Delhi
South
DELHI
110049
India |
| Phone |
9953088485 |
| Fax |
|
| Email |
reemapawankumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rimple Sharma |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No 4,College of Nursing, Old OT Block, AIIMS, New Delhi
South
DELHI
110049
India |
| Phone |
9953088485 |
| Fax |
|
| Email |
reemapawankumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rimple Sharma |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No 4,College of Nursing, Old OT Block, AIIMS, New Delhi
South
DELHI
110049
India |
| Phone |
9953088485 |
| Fax |
|
| Email |
reemapawankumar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS, New Delhi |
| Address |
AIIMS, Ansari Nagar East, New Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Rimple Sharma |
AIIMS |
Chest Clinic, Paediatric OPD, AIIMS, New Delhi
South
DELHI |
9953088485
reemapawankumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstituteEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Parents of children having Cystic Fibrosis |
| Patients |
(1) ICD-10 Condition: E841||Cystic fibrosis with intestinal manifestations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Nutritional Counselling |
Routine nutritional counselling will be provided to control group. |
| Intervention |
Nutritional intervention Package |
A combination of structured dietary counselling and food reciepes provided to the children with CF which are capable of providing additional calories; 200 Kcal/ day to infant/ toddler, 400 Kcal/ day to pre-schooler and 600 Kcal/day to school going children/ adolescent. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children with Cystic Fibrosis having Age between 6 months- 18 years, Understands Hindi or English language, Whose caregivers are willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Parents of children who have co-morbidities and are critically ill or admitted. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| nutritional Status of children with cystic fibrosis including height, weight, mid upper arm circumference, skin fold thickness and BMI |
3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| quality of life of children, Compliance to nutritional intervention, Palatability of recipies |
6 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
13/10/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study focuses to assess the impact of a nutritional intervention package (NIP) on children with cystic fibrosis with the view to develop a Cystic Fibrosis Home Management (CFHM) App to facilitate dissemination of general information about the disease and structured nutritional counselling to the parents of children with CF. |