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Comparative study of the effectiveness of self-management and group management on weight loss by low calorie diet in Nurses : A simultaneous combined study

Protocol summary

Study aim
Comparative determination of self-management and group management effectiveness on weight loss of nurses
Design
96 nurses and each hospital, for an intervention method, and assigning samples to study groups non-randomly: In each group: group diet , individual and control diet: 32 nurses
Settings and conduct
The nurses from Poursina, Razi, Al-Zahra, Heshmat and Shafa hospitals.. Nurses at Poursina and Razi hospitals: individual diets, nurses at Heshmat and Shafa hospitals: group diets. The nurses of Al-Zahra Hospital: control group will not receive any intervention.
Participants/Inclusion and exclusion criteria
BMI of more than 25 kg /m2, age over 18 years, not having a weight loss program in the last 6 months, not using other weight loss methods such as medication and exercise during the study period. People with diabetes, cancer, kidney failure, and patients taking nonsteroidal anti-inflammatory drugs are not included in the study Criteria for non-inclusion: Personal reluctance to participate in the study and pregnancy and lactation
Intervention groups
Poursina & Razi hospitals: diet individual management, Heshmat & Shafa hospitals: group management, Al-Zahra hospital: control group.For intervention group are prescribed 8 weeks of diet(55% carbohydrate, 15% protein & 30% fat) to lose weight. The energy required at the beginning, will be given to the person based on the person's age, height, current weight and 1000 calories less. Individual will be prohibited from taking weight loss drugs and strenuous physical activity and will be asked to walk 30 minutes a day.At the beginning, weeks 4(middle of the study) & week 8 (end of the study), weight, height, waist were measured with valid and reliable tools and BMI was calculated and no intervention was performed in the control group. The consequences of the individual regimen and group regimens are compared.
Main outcome variables
Weight Loss

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210528051417N1
Registration date: 2021-08-20, 1400/05/29
Registration timing: registered_while_recruiting

Last update: 2021-08-20, 1400/05/29
Update count: 0
Registration date
2021-08-20, 1400/05/29
Registrant information
Name
Parand Pourghane
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4256 5052
Email address
pourghanep@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-10, 1400/03/20
Expected recruitment end date
2022-05-10, 1401/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effectiveness of self-management and group management on weight loss by low calorie diet in Nurses : A simultaneous combined study
Public title
Comparative study of the effectiveness of self-management and group management on weight loss by low calorie diet in Nurses
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a body mass index of more than 25 kg / m2 Age over 18 years Not having a weight loss program in the last 6 months Not using weight loss medication Not having exercise during the study period Not having diabetes Not having cancer Not having kidney failure Not having not take non steroidal anti-inflammatory drugs
Exclusion criteria:
Personal reluctance to participate in the study pregnancy lactation
Age
From 60 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Not randomized
Randomization description
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
کمیته‌ اخلاق در پژوهش دانشگاه علوم پزشکی گیلان
Street address
Shahid Sheikhi
City
Guilan. Langroud
Province
Guilan
Postal code
4477166595
Approval date
2021-05-30, 1400/03/09
Ethics committee reference number
IR.GUMS.REC.1399.463

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Weight Loss
Timepoint
Along with recording demographic information, at the beginning of the study, week 4 (middle of the study) and week 8 after the start of the study (actually the end of the study), weight, height, waist indices and body mass index are also calculated.
Method of measurement
To measure the height and weight of the subjects, a lever scale with an accuracy of 0.1 kg connected to a calibrated height gauge with an accuracy of 0.1 cm is used. The height and weight of people are measured without shoes and with minimal clothing. Finally, the Body Mass Index is calculated based on the formula. People's waist is also measured using a tape measure

Secondary outcomes

empty

Intervention groups

1

Description
In the individual diet therapy group, diet training will be by an individual nutritionist. Educational content is determined based on demographic information and the amount of weight loss required. In face-to-face training sessions, at the beginning of the study, the fourth and last week of the study, training sessions are held for an average of one hour. Depending on your weight, diet, and the list of high-calorie foods you should eliminate from your diet, healthy and low-calorie foods, how to distribute food throughout the day and breakfast, lunch and dinner, and snacks are explained.
Category
Lifestyle

2

Description
In the group with group therapy regimen, through groups formed in WhatsApp, the necessary information like a indiuvidual regime will be provided to individuals and individuals will share their experiences and problems with other members. Also, in the intervals between sessions, communication will be established with group members through social channels to encourage people to follow a diet.
Category
Lifestyle

3

Description
Control group: Control group: Al-Zahra hospital: control group without intervention
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Poursina, Razi, Al-Zahra, Heshmat, Shafa hospitals
Full name of responsible person
Parand Pourghane
Street address
Shahid Sheikhi. College of Nursing & Midwifery
City
گیلان. لنگرودGuilan.Langroud
Province
Guilan
Postal code
4477163485
Phone
+98 13 4256 5052
Email
pourghanep@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Naghipour
Street address
Shahid Sheikhi Street
City
Langroud
Province
Guilan
Postal code
4477163485
Phone
+98 13 4256 5052
Email
pourghanep@gmail.com
Grant name
Vice Chancellor for Research, Guilan University of Medical Sciences, Iran
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Parand Pourghane
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Sheikhi Street
City
Langroud
Province
Guilan
Postal code
4477163485
Phone
+98 13 4256 5052
Email
pourghanep@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Parand Pourghane
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Sheikhi Street
City
Langroud
Province
Guilan
Postal code
4477163485
Phone
+98 13 4256 5052
Email
pourghanep@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Parand Pourghane
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Sheikhi Street. College of Nursing & Midwifery
City
Langroud
Province
Guilan
Postal code
4477163485
Phone
+98 13 4256 5052
Fax
Email
pourghanep@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
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
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After obtaining the results will be mentioned
When the data will become available and for how long
After publishing the article
To whom data/document is available
All applicants
Under which criteria data/document could be used
Release the effect of the weight loss program / freely
From where data/document is obtainable
Individuals can submit a request by sending a message to the first author. Also, the results will be made available to the public in the form of a published article.
What processes are involved for a request to access data/document
Demand for first author or correspond author
Comments
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