To determine the dominant eating trigger & the effects of a tailored nursing intervention on controlling such triggers.
Design
A quasi-experimental comparative design was employed to achieve the aforementioned objectives. 64 subjects will be assigned to Join the study group. the rest will be in the control group. The total sample size would be 128 subjects.
Settings and conduct
The setting of the intended study will be a specialized obesity control center. The conduct of the trial includes the recruitment, intervention, & followup phases. After recruitment, the subjects will be armed with orally & in written form instructions to enable them managing their dominant eating trigger & controlling their body weight. The following up phase includes monitoring the body weight after 4 weeks from the intervention phase, to examine the effectiveness of the intervention on the bodyweight.
Participants/Inclusion and exclusion criteria
Inclusion
1.Consent and compliance with all aspects of the study protocol, methods, providing data during follow-up
2. Male & female patients, who are 18-70 years old at the time of the data collection phase
3. Voluntarily seeking professional help from Obesity Control Centers in Baghdad City
Exclusion
1. Morbidly ill subjects, whereas their physical & mental capacity, are impaired
2. Involvement with any other ongoing studies.
3. Medically diagnosed with psychotic diseases
Intervention groups
The intervention group subjects (n=64)will respond to “What Triggers Your Eating? Questionnaire”. This mandatory step will help in categorizing the subjects according to their dominant eating trigger(s). Subjects will be armed with orally & in written form instructions to manage their dominant eating trigger & controlling their body weight.
The subjects (n=64) in the control group will not be given any instructions during the study course.
Main outcome variables
Bodyweight in Kg
General information
Reason for update
Acronym
Targeting Eating Triggers Trial (TETT)
IRCT registration information
IRCT registration number:IRCT20190809044485N1
Registration date:2019-09-28, 1398/07/06
Registration timing:registered_while_recruiting
Last update:2019-09-28, 1398/07/06
Update count:0
Registration date
2019-09-28, 1398/07/06
Registrant information
Name
Sadeq AL-Fayyadh
Name of organization / entity
University of Baghdad, College of Nursing
Country
Iraq
Phone
+964 1 521 1494
Email address
s.al-fayyadh@conursing.uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-27, 1398/07/05
Expected recruitment end date
2019-10-29, 1398/08/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Influence of A Tailored Nurse-Led Intervention on Controlling Body Weight among Clients Who are Medically Diagnosed with Obesity
Public title
Targeting Eating Triggers: A Tailored Nurse-led Intervention for Body Weight Control
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Consent and compliance with all aspects of the study protocol, methods, providing data during follow-up contact
Male & female patients, who are 18-70 years old at the time of data collection phase
Voluntarily seeking professional help from Obesity Control Centers in Baghdad City
Exclusion criteria:
Involvement with any other ongoing studies.
Medically diagnosed with psychotic diseases
Morbidly ill subjects, whereas their physical & mental capacity are impaired
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
In order to maintain a transparent and scientific-based randomization process, simple randomization will be used in assigning participants (individuals: persons who are medically diagnosed with obesity), to treatment and control groups, assuming that each participant has an equal chance of being assigned to any group. The simple randomization procedure would involve throwing a dice (eg, below and equal to 3 = control, over 3 = treatment). No allocation concealment will be carried out.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethical Approval Committee, at the College of Nursing
Street address
Bab AL-Muadum,
City
Baghdad
Postal code
10001
Approval date
2017-12-03, 1396/09/12
Ethics committee reference number
2193
Health conditions studied
1
Description of health condition studied
Overweight & Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Body weight in Kg
Timepoint
The body weight will be initially measured at the first meeting with the target subject before offering the educational intervention. After four weeks of the first meeting, the body weight will be re-checked to examine the effectiveness of the intervention on the body weight
Method of measurement
Self-report of body weight reduction in Kg by calculating the Body Mass Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The starting point of the interventional phase will start by asking the subjects to respond to “What Triggers Your Eating? Questionnaire” (Nash, 1997). This mandatory step will help in categorizing the subjects according to their dominant eating trigger. Interventional group subjects in the intervention group will be armed with orally and in a written form simple, yet specific instructions to enable them managing their dominant eating trigger. The experimental group will be contacted after 30 days to see the influence of following the given instruction on the subject’s body weight.
Category
Lifestyle
2
Description
Control group: It is planned that 64 subjects will be requited to be in this group. After determining their eating behavior dominant trigger, no instructions will be given to the subjects in the control group during the study course.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Obesity Control Center at AlKindy School of Medicine
Full name of responsible person
Dr. Mohammed Abdalmahdi AL-Qurtas
Street address
Alnahdah Square, Alkindy School of Medicine Campus
City
Baghdad
Postal code
10001
Phone
+964 1 415 0076
Email
info@kme.uofbaghdad.edu.iq
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Professor Iqbal Ghanim Muala, PhD. Dean
Street address
Bab AL-Muadum campus
City
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
deanship_Bagh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The author of the trial is the funding source
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Baghdad, College of Nursing
Full name of responsible person
Sadeq AL-Fayyadh
Position
Faculty Member-A Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Al Karkh,Ajnadine neighborhood, House No 3, Street No 62, Section No 863
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
s.al-fayyadh@conursing.uobaghdad.edu.iq
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Baghdad, College of Nursing
Full name of responsible person
Sadeq AL-Fayyadh
Position
Faculty member-Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Baghdad, Al Karkh,Ajnadine neighborhood
City
Baghdad
Province
Non-US/Non-Canadian
Postal code
10001
Phone
+964 1 521 1494
Fax
Email
s.al-fayyadh@conursing.uobaghdad.edu.iq
Person responsible for updating data
Contact
Name of organization / entity
University of Baghdad, College of Nursing
Full name of responsible person
Sadeq AL-Fayyadh
Position
Faculty member-Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Al Karkh, Ajnadine neighborhood, House No 3, Street No 62, Section No 863
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Fax
Email
s.al-fayyadh@conursing.uobaghdad.edu.iq
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The researcher is acknowledging the scientific community to have verifiable findings of the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals.
When the data will become available and for how long
God willing, once finishing the process of data collection, analysis and successfully publishing the manuscript, all the related files will become available for 6 months after publications
To whom data/document is available
All the related files will be shared with any scientific interested parties.
Under which criteria data/document could be used
It may be used after seeking the author's permission and acknowledging his contribution.
From where data/document is obtainable
The author's professional e-mail that will be available with the published manuscript can be used to contact the author. e-Mail: s.al-fayyadh@conursing.uobaghdad.edu.iq
What processes are involved for a request to access data/document
N/A
Comments
Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfiling their academic endeavours.