| CTRI Number |
CTRI/2026/02/102781 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
26/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Family-Based Health Education Program to Improve Health Knowledge, Lifestyle Practices, and Physical Health of Adolescent Girls |
|
Scientific Title of Study
|
A quasi-experimental study to assess the effectiveness of Family Centered Nurturance Package (FCNP) on knowledge, life style practices and bio-physiological parameters regarding adolescent health among girls at selected setting |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arockia Jesi S |
| Designation |
Associate Professor |
| Affiliation |
Omayal Achi College of Nursing |
| Address |
Shalom Garden
No.210 2nd street
Valluvar Nagar
Puzhal,Chennai-600066
Obstetrics and Gynaecological Nursing Department,
Faculty Room No:01
No.45 Ambattur road,Puzhal,Chennai-600066
Chennai
TAMIL NADU
600066
India |
| Phone |
09750591878 |
| Fax |
|
| Email |
jesiblessing@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arockia Jesi S |
| Designation |
Associate Professor |
| Affiliation |
Omayal Achi College of Nursing |
| Address |
Shalom Garden
No.210 2nd street
Valluvar Nagar
Puzhal,Chennai-600066
Obstetrics and Gynaecological Nursing Department,
Head of the department(HOD)
Room No:05
No.45 Ambattur road,Puzhal,Chennai-600066
Chennai
TAMIL NADU
600066
India |
| Phone |
09750591878 |
| Fax |
|
| Email |
jesiblessing@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arockia Jesi S |
| Designation |
Associate Professor |
| Affiliation |
Omayal Achi College of Nursing |
| Address |
Shalom Garden
No.210 2nd street
Valluvar Nagar
Puzhal,Chennai-600066
Community Health Nursing Dept HOD,Room No:03
No.45 Ambattur road,Puzhal,Chennai-600066
Chennai
TAMIL NADU
600066
India |
| Phone |
09750591878 |
| Fax |
|
| Email |
jesiblessing@gmail.com |
|
|
Source of Monetary or Material Support
|
| Selected Villages adopted by Omayal Achi Community Health Centre
Arakkambakkam, Tamil Nadu 600055, India |
|
|
Primary Sponsor
|
| Name |
MrsArockia JesiS |
| Address |
Omayal Achi College of Nursing
45, Ambattur Road,
Surappattu Road, Kathirvedu,
Puzhal, Tiruvallur – 600066,
Tamil Nadu, India |
| Type of Sponsor |
Other [By own] |
|
|
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 |
| DrAmuthaT |
selected rural villages adopted by Omayal Achi Community Health Centre |
53VH+95V, Arakkambakkam,
Tamil Nadu 600055, India
Thiruvallur
TAMIL NADU |
9840459157
amuthaocn@gmail.com |
|
|
Details of Ethics Committee
|
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescent health – physical psychological and reproductive health |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Family Centered Nurturance Package |
General adolescent health (physical, psychological, and reproductive)
Healthy lifestyle practices (nutrition and exercise)
Family support strategies to nurture adolescent well-being
The Family-Centered Nurturance Package was administered over a period of 4 weeks, consisting of one session per week, with each session lasting approximately 45–50 minutes. |
| Comparator Agent |
No structured intervention |
Routine care |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Female |
| Details |
1.Adolescent girls who are between 13–17 years of age.
2.Adolescent girls who have attained menarche.
3.Adolescent girls who are residing in the adopted villages of Omayal Achi Community Health Centre (OACHC).
4.Adolescent girls who have menstrual irregularities, underweight, overweight, or mild to moderate anemia.
5.Adolescent girls who have a primary caretaker (either mother or father) who is directly involved in nurturing their physical, psychological, and reproductive health.
6.Adolescent girls who are able to understand and speak Tamil or English. |
|
| ExclusionCriteria |
| Details |
1.Adolescent girls who are currently receiving medical treatment for anemia.
2.Adolescent girls who have previously undergone the same or a similar type of interventional program.
3.Adolescent girls who have physical, mental, or sensory impairments that may interfere with participation in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in knowledge regarding adolescent health among adolescent girls, measured using a structured knowledge questionnaire. |
Pre-test and Post-test (15th day after intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Lifestyle Practices:
Changes in lifestyle practices of adolescent girls (e.g., diet and physical activity)
Measured using lifestyle practices checklist.
Bio-Physiological Parameters:
Changes in physical health indicators, such as:
Height, weight, BMI,waist hip ratio and HB by using in vivo bio physiological parameters chart. |
For Life style practices:Pre-test and Post-test (1st,3rd and 6th month after intervention).
For Bio-Physiological Parameters:Pre-test and Post-test (3rd and 6th month after intervention) |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
20/02/2026 |
| 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="0"
Months="6"
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
|
|
Brief Summary
|
This study aims to assess the effectiveness of a Family Centered Nurturance Package FCNP on improving knowledge lifestyle practices and biophysiological parameters of adolescent girls aged 13 to 19 years in Arakkambakkam Thiruvallur District Tamil Nadu India The intervention includes structured health education sessions and family involvement The study will compare the outcomes in an experimental group receiving the FCNP with a control group receiving routine care The study uses a quasi experimental non randomized pre test post test design with 110 adolescent girls in the experimental group and 110 in the control group The primary outcome is knowledge regarding adolescent health Secondary outcomes include lifestyle practices and bio physiological parameters The total duration of the study is approximately six months |