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The effect of continuous care model on body mass index and lifestyle of obese middle-aged

Protocol summary

Summary
The present study aims to determine the effects of continuous care model on BMI and life style of the obese middle-aged. In this semi-experimental, 105 middle-aged individuals, aged 40-60, whose BMI was over 10, had used no lipid lowering drug over the last three months, followed no special diet, had no diagnosed high blood pressure, diabetes, liver disease, kidney disease, and depression, and were literate were randomly selected and put into two experimental (52 individuals) and control (53 individuals) groups. First, sampling was done in four health centers in Gonabad based on entry criteria, population covered, and availability. Then, in each center these samples were put into experimental and control groups through random allocation. The intervention schedule for the experimental group took three months which included familiarizing, sensitizing, controlling, and evaluating. There was no intervention in control group. Health-promoting lifestyle questionnaire(HPLP), height, and weight of the participants of the groups were recorded before and one, two, and three months after intervention. The research instruments included a meter, a scale, and a valid and reliable questionnaire which was filled out by the participants before and one, two, and three months after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016070428790N1
Registration date: 2017-02-19, 1395/12/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-19, 1395/12/01
Registrant information
Name
Mitra Tavakolizadeh Nooghabi
Name of organization / entity
Gonabad Medical Univercity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 1829
Email address
tavakolizadeh.m@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Gonabad University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of continuous care model on body mass index and lifestyle of obese middle-aged
Public title
The effect of continuous care model on obesity management
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having BMI index higher than 10; following no special diet; having no diagnosed high blood pressure, diabetes, liver disease, kidney disease, and depression; having used no lipid lowering drug over the last three months; being able to read and write; having the ability to take care of themselves. Exclusion criteria:being unwilling to continue cooperation. being absent in more than two sessions of training course; having to make changes in medical treatment.
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 105
Randomization (investigator's opinion)
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
Regional Ethics Committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi
City
Gonabad
Postal code
9691793718
Approval date
2015-05-26, 1394/03/05
Ethics committee reference number
IR.GMU.REC.1394.3

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified Simple obesity NOS

Primary outcomes

1

Description
body mass index
Timepoint
before Intervention months the first, second and third interference
Method of measurement
The formula weight divided by the square of height in meters

Secondary outcomes

1

Description
life style
Timepoint
Before the intervention, one month, two months, three months after intervention
Method of measurement
Health promoting lifestyle questionnaire (HPLP II)

Intervention groups

1

Description
In the test group, continuous care model, including familiarizing, sensitizing, controlling and evaluating, will be carried out for three months. Height, weight, and Walker’s questionnaire of Health-promoting lifestyle was recorded and administered before and at one, two, three month intervals after study.
Category
Lifestyle

2

Description
Participants of the control group will receive common cares only.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Rural-urban health center (1)
Full name of responsible person
Ms Mahsa Dehghan
Street address
Gonabad, Ghadir Square
City
Gonabad

2

Recruitment center
Name of recruitment center
Rural-urban health center (2)
Full name of responsible person
Ms Eshaghi
Street address
Gonabad, Edalat street, Shahid Rajai front hall
City
Gonabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology Gonabad University of Medical Sciences
Full name of responsible person
Dr Ali Mohamadpoor
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mitra Tavakolizadeh Nooghabi
Position
Master of Nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi
City
Gonabad
Postal code
397
Phone
+98 51 5722 1829
Fax
Email
mehrialaviani@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Ali Delshad
Position
Master Of Nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi
City
Gonabad
Postal code
397
Phone
+98 53 3722 3028
Fax
Email
Delshad.a@gmu.ac.ir
Web page address
www.gmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Maragheh Faculty of Medical Sciences
Full name of responsible person
Mehri Alaviani
Position
M.A.
Other areas of specialty/work
Street address
Maragheh Faculty of Medical Sciences, next to Traffic Directorate, Moallem Shomali St.,
City
Maragheh
Postal code
397
Phone
+98 41 3727 6365
Fax
Email
mehrialaviani@gmail.com
Web page address
www.mrgums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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