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Investigating the effect of health coaching on weight loss of overweight students

Protocol summary

Study aim
Determining the effect of health coaching on weight control of overweight students Comparison of changes in weight, waist circumference and body mass index of students after the intervention in the two study groups Comparison of students' stress changes after intervention in two study groups Comparison of changes in students' physical activity scores after the intervention in the two study groups Determining the socio-demographic characteristics of students in both study groups before the intervention.
Design
Clinical trial with control group, with parallel groups, randomized, on 68 students
Settings and conduct
Faculty of Nursing and Midwifery, Shahid Beheshti University
Participants/Inclusion and exclusion criteria
Inclusion criteria include: female gender, students of the medical department, body mass index 25-35, overweight not caused by other underlying diseases, no history of participating in weight loss treatment programs, age over 18 years, Written consent It is conscious. Exclusion criteria upon entry and during the study include:Taking psychiatric drugs or psychological disorders, Having restrictive cardiovascular problems or physical disabilities, Absence of more than one session in coaching sessions, Suffering from an illness blood pressure
Intervention groups
After completing the questionnaire, coaching sessions will be coordinated for the intervention group. 15 to 30 minutes sessions will be held by phone once a week in the first 6 weeks. It is then terminated every two weeks until the participant reports that they have met their health goals.
Main outcome variables
The primary result is the weight of the students. Secondary outcome: waist circumference, body mass index, stress and physical activity in all fields.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240209060946N1
Registration date: 2024-06-05, 1403/03/16
Registration timing: registered_while_recruiting

Last update: 2024-06-05, 1403/03/16
Update count: 0
Registration date
2024-06-05, 1403/03/16
Registrant information
Name
فاطمه محمدیان
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7741 8352
Email address
d.mohammadian98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of health coaching on weight loss of overweight students
Public title
The effect of health coaching on weight loss of overweight students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
female gender medical students Body mass index 25 to 35 Excess weight is not caused by other underlying diseases No history of participating in weight loss treatment programs Age above 18 years Informed written consent
Exclusion criteria:
Taking psychiatric drugs or psychological disorders Have restrictive cardiovascular problems or physical disabilities Absence of more than one session in coaching sessions Suffering from high blood pressure disease
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Students who meet the criteria for entering the study will complete the International Physical Activity Questionnaire and the Cohen Perceived Stress Scale short form of 14 questions after obtaining written consent. In order to randomly allocate the samples in two intervention and control groups, the block randomization method will be used using a block of four. After selecting the eligible samples, the researcher will contact another colleague who has the randomization list and determine whether the sample will be in the intervention group or the control group. The placement of the samples in each group cannot be predicted in advance for the researcher. Then the students who are in the intervention group will be informed.
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
Ethics committee of Babol University of Medical Sciences
Street address
Ganj afruz sq. Babol University of Medical Sciences
City
babol
Province
Mazandaran
Postal code
4774547176
Approval date
2024-01-29, 1402/11/09
Ethics committee reference number
IR.MUBABOL.REC.1402.205

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
weight
Timepoint
At the beginning of the study (before the start of the intervention) and 4 months after the start of the study
Method of measurement
Digital scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After completing the questionnaire, coaching sessions will be held over the phone. Sessions last 15 to 30 minutes. In the first 6 weeks, it is held once a week. It will then be held every two weeks until the participant reports that they have achieved their health goals. The beginning and end of each call will be recorded in the notebook. Briefly, the goals of the coaching sessions include: promoting a positive approach through education and skills development, providing verbal and written access to evidence-based lifestyle information (how to control weight and physical activity), minimizing risky lifestyles, optimizing Establishing weight control management, methods of solving problems and planning activities, promoting active monitoring of weight gain and considering it important in controlling its side effects, including anxiety and stress. Four months after the start of the intervention, the questionnaires will be completed again by the participant and the anthropometric information will be recorded.
Category
Lifestyle

2

Description
Control group: In this group, only after the study and then 4 months after the start of the study, the questionnaire will be completed by the participants and the anthropometric information will be recorded by the researcher.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti School of Midwifery Nursing
Full name of responsible person
Fateme Mohammadian
Street address
The intersection of Valiasr and Niayesh streets
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
d.mohammadian98@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fateme Mohammadian
Street address
Ganj afruz street
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
D.mohammadian98@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fateme Mohammadian
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
The intersection of Valiasr and Niayesh streets
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
d.mohammadian98@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fateme Mohammadian
Position
instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti School of Midwifery and Nursing. Valiasr Street Intersection of Niayesh.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
d.mohammadian98@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fateme Mohammadian
Position
Non-faculty instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
no 72. Teymuri Ave. Qasemzade Ave. Emamat Sq. Damavand Ave. tehranno
City
Tehran
Province
Tehran
Postal code
1741894514
Phone
+98 21 7741 8352
Email
d.mohammadian98@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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