Protocol summary
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Study aim
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Determining the effect of interventions based on Pender's health promotion model on preventive nutritional behaviors of colorectal cancer in first-degree relatives of patients with colorectal cancer.
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Design
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A trial, no blinded, controlled, parallel-group, randomized, phase 2 clinical trial involving 136 participants
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Settings and conduct
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The intervention group received four two-hour educational sessions, one session per week (4 weeks), based on constructs of pender's model. The study conducted to Namazi, Saadi, and Amir Hospitals affiliated with Shiraz University of Medical Sciences.
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Participants/Inclusion and exclusion criteria
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The participants were first-degree relatives of patients with colorectal cancer.
Inclusion criteria are:Being first-degree relatives of the patients with colorectal cancer; including their sister, brother, father, mother, and children; Confirmed diagnosis of colorectal cancer in the patient as documented in the medical record; The ages of between 18 - 60 years; Literate.
Exclusion criteria were: Not participated in any educational workshops. previously; Lack of a chronic disease; Lack of mental retardation.
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Intervention groups
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Intervention group: The research intervention was nutritional interventions based on Pender's health promotion model.
Control group: Only routine educational interventions were provided by the healthcare personnel for the control group.
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Main outcome variables
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The primary outcome variable was colorectal cancer preventive nutritional behaviors, constructs of health promotion model of Pender, and Predictive constructs of nutritional behaviors to prevent colorectal cancer.
General information
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Reason for update
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The beginning and end date of recruitment of the patients was incorrectly recorded before the trial was registered. According to the new site, the information has been completed.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2015103124807N1
Registration date:
2016-05-06, 1395/02/17
Registration timing:
prospective
Last update:
2024-08-07, 1403/05/17
Update count:
1
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Registration date
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2016-05-06, 1395/02/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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research management of Yasuj Medical Sciences
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Expected recruitment start date
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2016-07-10, 1395/04/20
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Expected recruitment end date
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2016-10-15, 1395/07/24
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effects of Pender's Health Promotion Model application on preventive nutrition behaviors of colorectal cancer in first degree relatives of colorectal cancer patients.
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Public title
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The effect of Pender's model on nutrition behavior
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Being first-degree relatives of the patients with colorectal cancer, including their sister, brother, father, mother, and children
Confirmed diagnosis of colorectal cancer in the patient as documented in the medical record
The ages of between 18 - 60 years
Literate
Exclusion criteria:
Not participated in any educational workshops previously
Lack of a chronic disease
Lack of mental retardation
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
136
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The participants were first selected using Convenience sampling method and then randomly allocated to two intervention and control groups (68 people in each group) using 6-way and 4-way random block selection.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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No
Ethics committees
1
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Ethics committee
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Approval date
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2015-10-22, 1394/07/30
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Ethics committee reference number
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Yums.REC.1394.91
Health conditions studied
1
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Description of health condition studied
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cancer
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ICD-10 code
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Z80.0
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ICD-10 code description
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Family history of malignant neoplasm of digestive organs
Primary outcomes
1
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Description
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Preventable nutrition behavior, Constructs of Pender's model, and predictors of preventive nutritional behaviors.
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Timepoint
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before intervention and 3 months after intervention
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Method of measurement
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researcher-made questionnaire
Intervention groups
1
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Description
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intervention group divided to 2 groups and took part in 2 training sessions with focus on perceived efficacy, perceived barriers and profits. After 3 months, they completed questionnaire again during this time we reminded them with SMS or electronic massages.
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Category
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Prevention
2
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Description
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In control group wasn't done any intervention at the same time (of interventions for intervention group). After completion the interventions data and information will be analyzed and pretest and post test results for both groups will be compared and if it be positive same intervention will be done for control group.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yasouj University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable