Protocol summary

Summary
This study examines the impact of nurse telephone follow-up on the self-efficacy of nutritional behavior and physical activity in patients with nonalcoholic fatty liver disease (NAFLD). Inclusion criteria included capability to perform moderate physical activity; confirmed by medical professionals; accessibility to a telephone at home, while, exclusion criteria included a history of chronic liver disease; hyperthyroidism or hypothyroidism; diabetes mellitus; alcohol consumption; drug abuse.In this interventional study, we enrolled 60 patients (30 patients in control groups and 30 patients in case groups) with NAFLD. Selective sampling was used to randomize the participants into case and control groups. The patients received dietary advice from a nutritionist individually and were trained to perform physical activity. Telephone intervention in the case group lasted for 12 weeks; while, the control group did not receive any follow-ups by the researcher and were only followed up as usual by a specialist. Before and after intervention, Questionnaires related to the self-efficacy of dietary behavior and physical activity were completed by study participants and also measurements (height, weight and BMI) was done by the researcher and all the patients were referred to assess blood test and to determine the liver size by ultrasound. Finally, the impact of nurse telephone follow-up on the self-efficacy of nutritional behavior and physical activity in patients with nonalcoholic fatty liver examine by using the Statistics test.

General information

Acronym
NAFLD
IRCT registration information
IRCT registration number: IRCT2015040411691N5
Registration date: 2015-06-21, 1394/03/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-06-21, 1394/03/31
Registrant information
Name
Fariba Ghodsbin Jahromi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4250
Email address
ghodsbin@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of nurses telephone follow-up (Telenursing) on the self-efficacy of dietary behavior and physical activity in patients with nonalcoholic fatty liver disease referred to subspeciality gastrointestinal Clinics of Shiraz
Public title
The Effect of nurses telephone follow-up on the self-efficacy of dietary behavior and physical activity in patients with nonalcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:19 years and over; the incidence of overweight or obesity; capability to perform moderate physical activity confirmed by medical professionals; accessibility to a telephone at home; lack of any speech and hearing problems. Exclusion criteria: history of chronic liver disease such as viral or drug hepatitis; confirmed diagnosis of Wilson diseases; primary hemochromatosis; hyperthyroidism or hypothyroidism; bile duct cancer; diabetes mellitus; obesity due to excessive use of corticosteroid; Cushing's syndrome; Addison syndrome; chronic infections such as tuberculosis; use of hepatotoxic drugs within the past 6 months; incidence of gall stones in the gallbladder having exposure to petrochemicals; alcohol consumption; drug abuse;genetic diseases related to lipid disorders.
Age
From 19 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Postal code
14336 - 71348
Approval date
2010-04-21, 1389/02/01
Ethics committee reference number
ct-92-9262-6602

Health conditions studied

1

Description of health condition studied
Nonalcoholic Fatty Liver
ICD-10 code
k75.8
ICD-10 code description
Other specified inflammatory liver diseases

Primary outcomes

1

Description
dietary behavior self efficacy
Timepoint
Before and three months after intervention
Method of measurement
dietary behavior self-efficacy Questionnaire ( sherer &madox)

2

Description
Physical activity self-efficacy
Timepoint
Before and three months after intervention
Method of measurement
Exercise Self-Efficacy Questionnaire( pender)

Secondary outcomes

1

Description
weight average
Timepoint
Before and three months after intervention.
Method of measurement
scale

2

Description
lipid average
Timepoint
Before and three months after intervention
Method of measurement
Blood test

3

Description
Liver Enzymes Average
Timepoint
Before and three months after intervention
Method of measurement
Blood test

4

Description
liver size average
Timepoint
Before and three months after intervention
Method of measurement
Ultrasound

Intervention groups

1

Description
Intervention group : Before and after intervention, Questionnaires related to the self-efficacy of dietary behavior and physical activity were completed by study participants .The patients received dietary advice from a nutritionist individually and were trained to perform physical activity. Telephone intervention in the Intervention group lasted for 12 weeks for following up the recommended diet and physical activity. Before and after intervention, measurements of weight, height and BMI of the patients was done by the researcher and all the patients to assess serum levels of AST, ALT, TG, LDL, HDL, Cholesterol and FBS and to determine the size of the liver by ultrasound were referred.
Category
Lifestyle

2

Description
Control group : Before and after intervention, Questionnaires related to the self-efficacy of dietary behavior and physical activity were completed by study participants .The patients received dietary advice from a nutritionist individually and were trained to perform physical activity. the case group did not receive any intervention by the researcher and were only followed up as usual by a specialist. Before and after intervention, measurements of weight, height and BMI of the patients was done by the researcher and all the patients to assess serum levels of AST, ALT, TG, LDL, HDL, Cholesterol and FBS and to determine the size of the liver by ultrasound were referred.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Sorur Javanmardi Fard
Street address
Namazi Hospital, Namazi Square, Zand Street, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Masoom Masoom Pur
Street address
Centeral Building of Shiraz University of Medical Sciences, Infront of the Felestin Street, Zand Street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fariba Ghodsbin
Position
Faculty Member and Instructor/Master degree
Other areas of specialty/work
Street address
Fatemeh(P.B.U.H) School of Nursing and Midwifery, Namazi Square, Zand Street, Shiraz
City
Shiraz
Postal code
71348-14336
Phone
+98 71 3230 5410
Fax
+98 32122430
Email
vcrdep@sums.ac.irghodsbin@sums.ac.ir
Web page address
www.sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fariba Ghodsbin
Position
Master Degree
Other areas of specialty/work
Street address
Fatemeh(P.B.U.H) School of Nursing and Midwifery, Namazi Square, Zand Street, Shiraz
City
Shiraz
Postal code
71348-14336
Phone
+98 71 3230 5410
Fax
+98 32122430
Email
vcrdep@sums.ac.irghodsbin@sums.ac.ir
Web page address
www.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fariba Ghodsbin
Position
Faculty Member and Instructor/Master degree
Other areas of specialty/work
Street address
Fatemeh(P.B.U.H) School of Nursing and Midwifery, Namazi Square, Zand Street, Shiraz
City
Shiraz
Postal code
71348-14336
Phone
+98 71 3230 5410
Fax
+98 32122430
Email
vcrdep@sums.ac.irghodsbin@sums.ac.ir
Web page address
www.sums.ac.ir

Sharing plan

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