| CTRI Number |
CTRI/2020/03/024305 [Registered on: 27/03/2020] Trial Registered Prospectively |
| Last Modified On: |
08/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The effect of health information for dental care sent through text-messages on the dental care practices of pregnant women attending a health clinic in urban Delhi |
|
Scientific Title of Study
|
The effect of a text-messaging intervention on oral self-care practices in antenatal women at
an urban primary health clinic in Delhi: A pilot randomized control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suneela Garg |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Room No. 359
Dept. of Community Medicine
Maulana Azad Medical College
New Delhi
Central
DELHI
110002
India |
| Phone |
9968604242 |
| Fax |
|
| Email |
gargsuneela@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saurav Basu |
| Designation |
Senior Resident |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Room No. 358
Dept. of Community Medicine
Maulana Azad Medical College
New Delhi
Central
DELHI
110002
India |
| Phone |
8447527452 |
| Fax |
|
| Email |
saurav.basu1983@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saurav Basu |
| Designation |
Senior Resident |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Room No. 358
Dept. of Community Medicine
Maulana Azad Medical College
New Delhi
Central
DELHI
110002
India |
| Phone |
8447527452 |
| Fax |
|
| Email |
saurav.basu1983@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Community Medicine, Maulana Azad Medical College, New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2 Bahadur Shah Zafar Marg
New Delhi - 110002 |
| 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 Suneela Garg |
Dept. of Community Medicine, Maulana Azad Medical College |
Room No. 359
Dept. of Community Medicine, Maulana Azad Medical College
Central
DELHI |
9968604242
gargsuneela@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College & Associated hospitals, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All adult pregnant women with period of gestation up-to 20 weeks. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Structured educational intervention |
Participants in the educational intervention group, will receive a face-
to-face group-based structured educational intervention session using focused awareness and
motivation approaches for oral health promotion. |
| Intervention |
Text-message(mHealth) intervention |
A text-message will be sent daily to the participants in the mHealth intervention
group during a period of 30 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
1. All adult pregnant women with period of gestation up-to 20 weeks
2. Women that consent to receive health information via text-messages |
|
| ExclusionCriteria |
| Details |
1. Women who are unable to read text-messages
2. Women who do not have access to a mobile phone |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
(1). Proportion of women practicing twice daily brushing
(2). Dental self-efficacy |
0 and 31 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(1) Knowledge and awareness of oral hygiene in pregnancy
(2) Interdental cleaning practice |
Baseline, 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
01/04/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background:
Oral health promotion by improving the awareness, self-care practices and treatment
seeking behaviour of pregnant women needs prioritization in Indian health
settings. There is growing recognition of the role of mHealth (mobile telephone
based audio or text-message interventions for health promotion) can be applied
for behaviour change in vulnerable populations.
Lacunae
is existing knowledge: To the best of our knowledge, no study has been conducted
in India, which
has applied mHealth
interventions for improving
the knowledge, attitude and practice of oral health care in pregnant
women.
Objective:
To study the effect of a self-designed text-message intervention package
compared with a structured health educational session on knowledge, attitude
and practices related to oral care and hygiene in pregnant women.
Material
and methods:
Study
design: A Randomized Control Trial parallel design superiority trial comparing
standard care and face-to-face structured educational intervention (n = 36) and
standard care plus a mobile phone based SMS intervention (n = 36) for 1 month
in antenatal women.
Study
population: antenatal women up-to 20 weeks of age undergoing antenatal care
utilization at the Urban Health Center, Gokalpuri affiliated to the Dept. of
Community Medicine, Maulana Azad Medical College, New Delhi
Inclusion Criteria
1.
All adult pregnant women with period of gestation up-to 20 weeks
2.
Women that consent to receive health information via text-messages
Exclusion Criteria
1.
Women who are unable to read text-messages
2.
Women who do not have access to a mobile phone
Primary Outcomes:
(1). Proportion of women practicing twice
daily brushing
(2). Dental self-efficacy
Intervention:
A text-message will be sent daily to the participants in the mHealth
intervention group during a period of 30 days. Written and informed consent
will be taken from participants.
Statistical
analysis: Data will be analysed with IBM SPSS Version 25. |