The main objective of this study is to determine the effect of Family-Centered Empowerment Model on feeding style and physical activity in patients with asthma. This is a randomized clinical trial study. The sample size consists of 70 patients with asthma admitted to Amiralmomenin Hospital of Zabol. All patients were selected on available method and were randomly divided to intervention (35 patients) and control groups (35 patients). The inclusion criteria include: suffering with asthma, experiencing asthma attack at least once in the last six months; literacy; lack of other chronic diseases. In addition, exclusion criteria include: lack of participation in all meetings of the intervention. Intervention will be carried out as implementation of the empowerment program on four steps (increased perceived threat, problem solving, educational participation, and evaluation) for samples of the study consisting of five 45-minute sessions of group counseling within two days a week. Participants in the control group received no intervention and are only subject to typical trainings.
Information is collected in the intervention and control groups using a demographic questionnaire, feeding style self-made questionnaire and Beck standard questionnaire in four phases of before the intervention and one week, one month and three months after intervention. The main outcome variables are to examine the effects of implementing empowerment program on the feeding style and physical activity in patients with asthma.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071428927N1
Registration date:2016-09-04, 1395/06/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-04, 1395/06/14
Registrant information
Name
Fatemeh Khajehmahmoud
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1400
Email address
khajeh.f@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Birjand University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of family-centered empowerment pattern on nutrition style and physical activity in patients with asthma
Public title
Effect of family-centered empowerment pattern on nutrition style and physical activity in patients with asthma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Suffering from asthma; experiencing asthma attack at least once in the last six months; literacy; lack of other chronic diseases; patients aged 18-60 years. Exclusion Criteria: Suffering with known physical and mental illnesses; lack of participation in all meetings of the intervention.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Birjand University of Medical Sciences
Street address
Ghaffari Street, Birjand University of Medical Sciences, Birjand
City
Birjand
Postal code
9717853577
Approval date
2016-03-12, 1394/12/22
Ethics committee reference number
Ir.bums.1394.367
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Mixed asthma Combination of conditions listed in J45.0 and J45.1
Primary outcomes
1
Description
Nutrition Style
Timepoint
Before the intervention and one week, one month, and three months after the intervention
Method of measurement
questionaire
2
Description
Physical Activity
Timepoint
Before the intervention and one week, one month, and three months after the intervention
Method of measurement
questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention will implement as a discussion group of 6-8 people over 3-5 meetings (maximum 45 minutes) as follows: The first step in Family-Centered Empowerment Model is increasing the threat perceived by the patient in relation to the nature of the disease and the potential side effects of the disease and treatment using discussion groups. The second phase is to use problem-solving skills in groups of 6-8 persons in which the patients are faced with problems and problem-solving process. Patients express their problems in this phase and discuss on how to solve them according to their viewpoints and subsequently participate in selecting the best solution. In the third phase, patients are required to transfer the contents discussed in training sessions to their active family member through flash cards using educational participation to promote self-esteem. In the fourth stage, process evaluation will be done with special tools to measure empowerment and the patients’ empowerment and their active family member are studied in about 7-10 days after the intervention.
Category
Lifestyle
2
Description
In the control group did not perform certain actions
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Fatemeh Khajehmahmoud
Street address
3 Kms away from Zabol- Zahedan road
City
Zabol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Birjand University of Medical Sciences
Full name of responsible person
Dr. Tooba Kazemi
Street address
3th floor, Birjand University of Medical Sciences, Ayatollah Ghaffari Street, Birjand
City
Birjand
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, Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Fatemeh Khajemahmoud
Position
MSc Student in Nursing
Other areas of specialty/work
Street address
Ghaffari Street, Birjand University of Medical Sciences, Birjand
City
Birjand
Postal code
Phone
+98 56 3238 1400
Fax
Email
fatemekhaje34@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Gholamhossein Mahmoudirad
Position
Associate Professor
Other areas of specialty/work
Street address
Ghaffari Street, Birjand University of Medical Sciences, Birjand
City
Birjand
Postal code
Phone
+98 56 3238 1400
Fax
Email
mahmoudirad@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Fatemeh Khajehmahmoud
Position
MSc Student in Nursing
Other areas of specialty/work
Street address
Ghaffari Street, Birjand University of Medical Sciences, Birjand
City
Birjand
Postal code
Phone
00
Fax
Email
fatemekhaje34@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)