Dietary Fat ReductionNCT05949918
Efficacy of a Stage-Matched Intervention Based on The Transtheoretical Model of Change in Dietary Fat Reduction
A study testing Stage-matched interventions in people with Dietary Fat Reduction, run by University of Baghdad at 1 site in Iraq.
Trial summary
This study aims to examine the efficacy of a Stage-Matched Intervention based on The Transtheoretical Model of Change in dietary fat reduction among female high school students. Read more about this study
- Who is it for?
- Ages 15 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Fat Reduction
- What is being tested?
- Stage-matched interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteIraq
- Study dates
- 12 Sep 2023to 24 Mar 2024
- 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 15 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- High school male students who do not experience any psychiatric-mental disorder.
Who cannot join
- High school male students who experience any psychiatric-mental disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Stage-Matched Intervention Based on The Transtheoretical Model of Change in Dietary Fat Reduction Among Female High School Students: A Randomized Controlled Trial
This study aims to examine the efficacy of a Stage-Matched Intervention based on The Transtheoretical Model of Change in dietary fat reduction among female high school students.
Read the detailed description
This study aims to examine the efficacy of a Stage-Matched Intervention based on The Transtheoretical Model of Change in dietary fat reduction among female high school students.
The study intervention will be designed based on each Stage of Change of the Transtheoretical Model of Change in that participants in each Stage of Change will receive the intervention that matches the Stage of Change they would be in.
A 12-week interval would be considered between administering the intervention and posttest 1 and the same interval would be used between posttest 1 and posttest 2.
- Conditions
- Dietary Fat Reduction
- Being tested
- Stage-matched interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stage-matched interventionsBehavioural
The study intervention will be designed based on each Stage of Change of the Transtheoretical Model of Change in that participants in each Stage of Change will receive the intervention that matches the Stage of Change they would be in.
A 12-week interval would be considered between administering the intervention and posttest 1 and the same interval would be used between posttest 1 and posttest 2.
| Study group | Role | What they receive |
|---|---|---|
| Precontemplation, Contemplation, Preparation, Action, and Maintenance-based intervention | Experimental | The intervention that would consider the Processes of Change that people use when they would be in the Precontemplation Stage of Change. Receives: Behavioral: Stage-matched interventions |
| Contemplation-based intervention | Experimental | The intervention that would consider the Processes of Change that people use when they would be in the Contemplation Stage of Change. Receives: Behavioral: Stage-matched interventions |
| Preparation-based intervention | Experimental | The intervention that would consider the Processes of Change that people use when they would be in the Preparation Stage of Change. Receives: Behavioral: Stage-matched interventions |
| Action-based intervention | Experimental | The intervention that would consider the Processes of Change that people use when they would be in the Action Stage of Change. Receives: Behavioral: Stage-matched interventions |
| Maintenance-based intervention | Experimental | The intervention that would consider the Processes of Change that people use when they would be in the Maintenance Stage of Change. Receives: Behavioral: Stage-matched interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stages of Change Scale for Dietary Fat Reduction
Stages of Change Scale for Dietary Fat Reduction measures individuals' readiness to reduce dietary fat.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start12 Sep 2023
- Primary completion24 Mar 2024
- Study completion24 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary Fat ReductionStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Baqer Habeeb Abd Ali, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949918
- Sponsor's protocol ID
- Dietary Fat Reduction
- Status last verified
- Mar 2024
- First submitted
- 28 Jun 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Stage-Matched Intervention Based on The Transtheoretical Model of Change in Dietary Fat Reduction Among Female High School Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05949918
- Acronym / sponsor ID
- Dietary Fat Reduction
- Conditions
- Dietary Fat Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 24 Mar 2024 (actual)
- Study completion
- 24 Mar 2024 (actual)
- First posted
- 18 Jul 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.
This study aims to examine the efficacy of a Stage-Matched Intervention based on The Transtheoretical Model of Change in dietary fat reduction among female high school students.
Detailed description
This study aims to examine the efficacy of a Stage-Matched Intervention based on The Transtheoretical Model of Change in dietary fat reduction among female high school students.
The study intervention will be designed based on each Stage of Change of the Transtheoretical Model of Change in that participants in each Stage of Change will receive the intervention that matches the Stage of Change they would be in.
A 12-week interval would be considered between administering the intervention and posttest 1 and the same interval would be used between posttest 1 and posttest 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Precontemplation, Contemplation, Preparation, Action, and Maintenance-based intervention | Experimental | Behavioral: Stage-matched interventionsThe intervention that would consider the Processes of Change that people use when they would be in the Precontemplation Stage of Change. |
| Contemplation-based intervention | Experimental | Behavioral: Stage-matched interventionsThe intervention that would consider the Processes of Change that people use when they would be in the Contemplation Stage of Change. |
| Preparation-based intervention | Experimental | Behavioral: Stage-matched interventionsThe intervention that would consider the Processes of Change that people use when they would be in the Preparation Stage of Change. |
| Action-based intervention | Experimental | Behavioral: Stage-matched interventionsThe intervention that would consider the Processes of Change that people use when they would be in the Action Stage of Change. |
| Maintenance-based intervention | Experimental | Behavioral: Stage-matched interventionsThe intervention that would consider the Processes of Change that people use when they would be in the Maintenance Stage of Change. |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- High school male students who do not experience any psychiatric-mental disorder.
Key exclusion criteria (1 listed)
- High school male students who experience any psychiatric-mental disorder.
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 |
|---|---|---|
| Stage-matched interventionsThe study intervention will be designed based on each Stage of Change of the Transtheoretical Model of Change in that participants in each Stage of Change will receive the intervention that matches the Stage of Change they would be in. A 12-week interval would be considered between administering the intervention and posttest 1 and the same interval would be used between posttest 1 and posttest 2. | Behavioural | Action-based intervention, Contemplation-based intervention, Maintenance-based intervention, Precontemplation, Contemplation, Preparation, Action, and Maintenance-based intervention, Preparation-based intervention |
Primary outcome
Stages of Change Scale for Dietary Fat Reduction
Time frame: 6 months
Stages of Change Scale for Dietary Fat Reduction measures individuals' readiness to reduce dietary fat.
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 26 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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 Stage-matched interventions in people with Dietary Fat Reduction, run by University of Baghdad at 1 site in Iraq.
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 26 Mar 2024. 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 Iraq. 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?
Stages of Change Scale for Dietary Fat Reduction (time frame: 6 months). 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 26 Mar 2024.