Social BehaviorNCT05893589
The Impact of the Social Cognitive Theory Based Educational Program on Women-headed Households' Social Health : A Field Trial
A study testing test group in people with Social Behavior and Health Behavior, run by Gonabad University of Medical Sciences at 1 site in Iran.
Trial summary
The goal of this field trial was to compare in emale-headed households. The main question it aims to answer are: determine the effect of education based on social cognitive theory on the social health of female-headed households in female-headed households in Gonabad. Read more about this study
- Who is it for?
- Ages 20 to 64 years, women only
- Conditions the study is for
- Social Behavior, Health Behavior
- What is being tested?
- test group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIran
- Study dates
- 10 May 2021to 20 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent to participate in the study, being the head of the household, age range from 20 to 64 years, ability to speak and listen, reading and writing literacy, access to a mobile phone with Android operating system to receive educational messages (access to the Internet and virtual networks) or Having access to a person who will help him in using virtual networks, not suffering from acute diseases and hospitalization during the intervention.
Who cannot join
- Dissatisfaction to continue cooperation, not completing the questionnaire completely
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this field trial was to compare in emale-headed households. The main question it aims to answer are:
determine the effect of education based on social cognitive theory on the social health of female-headed households in female-headed households in Gonabad.
Women in the intervention group participated in face-to-face and virtual meetings based on social cognitive theory structures for 4 weeks. The control group did not receive any training related to the intervention.
- Conditions
- Social Behavior, Health Behavior
- Being tested
- test group
- Medical subject headings
- Social Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test groupOther
Women in the intervention group participated in face-to-face and virtual meetings based on social cognitive theory structures for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| test | Experimental | Not described Receives: Other: test group |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
social health
Social health is measured by the Keyes Social Health Questionnaire. This questionnaire
Measured: before
social health
Social health is measured by the Keyes Social Health Questionnaire. This questionnaire includes 20 questions and examines 5 subscales of social prosperity, social solidarity, social cohesion, social acceptance and social participation.relationships with others
Measured: After 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start10 May 2021
- Primary completion10 May 2021
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gonabad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atefeh Dehnoalian, Gonabad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893589
- Sponsor's protocol ID
- IR.GMU.REC.1398.172
- Status last verified
- May 2023
- First submitted
- 7 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Social Cognitive Theory Based Educational Program on Women-headed Households' Social Health : A Field Trial
- ClinicalTrials.gov ID
- NCT05893589
- Acronym / sponsor ID
- IR.GMU.REC.1398.172
- Conditions
- Social Behavior, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Gonabad University of Medical SciencesUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this field trial was to compare in emale-headed households. The main question it aims to answer are:
determine the effect of education based on social cognitive theory on the social health of female-headed households in female-headed households in Gonabad.
Women in the intervention group participated in face-to-face and virtual meetings based on social cognitive theory structures for 4 weeks. The control group did not receive any training related to the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test | Experimental | Other: test group |
| control group | No intervention | – |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Informed consent to participate in the study, being the head of the household, age range from 20 to 64 years, ability to speak and listen, reading and writing literacy, access to a mobile phone with Android operating system to receive educational messages (access to the Internet and virtual networks) or Having access to a person who will help him in using virtual networks, not suffering from acute diseases and hospitalization during the intervention.
Key exclusion criteria (1 listed)
- Dissatisfaction to continue cooperation, not completing the questionnaire completely
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| test groupWomen in the intervention group participated in face-to-face and virtual meetings based on social cognitive theory structures for 4 weeks | Other | test |
Primary outcome
social health
Time frame: before
Social health is measured by the Keyes Social Health Questionnaire. This questionnaire
social health
Time frame: After 4 weeks
Social health is measured by the Keyes Social Health Questionnaire. This questionnaire includes 20 questions and examines 5 subscales of social prosperity, social solidarity, social cohesion, social acceptance and social participation.relationships with others
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing test group in people with Social Behavior and Health Behavior, run by Gonabad University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
social health (time frame: before). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.