The effect of education based on health belief model on physical activity and dietary intake in nonalcoholic fatty liver disease patients

• Register: IRCT
• Last refreshed on: 30 August 2021
• Main ID: IRCT20210612051546N1
• Date of registration: 2021-07-12
• Prospective Registration: Yes
• Primary sponsor: Esfahan University of Medical Sciences
• Public title: The effect of education based on health belief model on physical activity and dietary intake in nonalcoholic fatty liver disease patients
• Scientific title: The effect of education based on health belief model on physical activity and dietary intake in nonalcoholic fatty liver disease patients
• Date of first enrolment: 2021-07-23
• Target sample size: 80
• Recruitment status: Recruiting
• URL: http://en.irct.ir/trial/56848
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Candidates who were eligible for participation in the study were randomly chosen and were assigned to the groups according to the random number table.
• Phase: N/A

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Asiyeh Pirzadeh
• Affiliation: Esfahan University of Medical Sciences

• Name: Nafiseh Tamadonpoor
• Affiliation: Esfahan University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: Diagnosis of non alcoholic fatty liver disease by physician
20 to 50 years’ old
Patients who agree to participate in the study
Ability to use smartphones and social media (Whats App)
Exclusion criteria: Medical prohibition for physical activity or have special diet
Using alcohol
Diagnosis of other diseases, including Liver disease, Biliary Disease, Autoimmune disease and Cancers
Pregnancy, lactation and menopause in women

Age minimum: 20 years
Age maximum: 50 years
Gender: Both

Health Condition(s) or Problem(s) studied

K76.0

Nonalcoholic fatty liver(NAFLD).
Fatty (change of) liver, not elsewhere classified

Intervention(s)

Intervention 1: After referral of the patient from the physician, all patients are examined based on criteria for entering the study and are described the goals of the plan to patients. If the patient wishes to participate in plan, the consent form will be given to sign it after the study. Candidates who were eligible for participation in the study were randomly chosen and were assigned to the groups according to the random number table. Health Belief Model questionnaire, International Physical Activity Questionnaire (IPAQ), 3-day food record will be completed before and after the intervention (2 months after the start of the intervention). also Liver enzymes (ALT, AST) and weight of patients will be measured before and after the intervention. The intervention group will receive messages via Whats App for 2 months, including clips, photos and podcasts about the severity of fatty liver disease, benefits and barriers to regular physical activity and healthy eating, intervention group will receive a self-care book on fatty liver disease, which includes a healthy lifestyle in fatty liver disease and self-assessment tables and the patient will be complete the book tables at the end of each week and send a photo for researcher. Intervention 2: Control group: Control group were follow their routine life for 2 months.

Primary Outcome(s)

Physical activity. Timepoint: At the beginning and end of intervention. Method of measurement: The International Physical Activity Questionnaire.

Dietary intake. Timepoint: At the beginning and end of intervention. Method of measurement: 3-day food record.

Secondary Outcome(s)

AST and ALT. Timepoint: At the beginning and end of intervention. Method of measurement: Blood sample.

Source(s) of Monetary Support

Esfahan University of Medical Sciences

Ethics review

Status: Approved
Approval date: 09/06/2021
Contact:

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