NutritionNCT02405611
A Multi-component Intervention on Improving Fruit and Vegetable Consumption in Teenagers and Their Mothers
A study testing behavioral and primary eduction in people with Nutrition, run by Qazvin University Of Medical Sciences at 2 sites in Iran.
Trial summary
This study is a longitudinal controlled trial that is designed to investigate the effectiveness of a multi-component intervention on improving fruit and vegetable consumption in teenagers and their mothers. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nutrition
- What is being tested?
- behavioral and primary eduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 2 sitesIran
- Study dates
- Mar 2015to Jun 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- They are not involved in the nutritional education
- Ability to understand Persian language Adolescents attending high schools in Qazvin
Who cannot join
- Does not meet inclusion criteria
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Department of Public Health, Qazvin University of Medical Sciences
Qazvin, Qazvin Province, 3419759811
The Organization for Education
Qazvin, Qazvin Province
About this study
This study is a longitudinal controlled trial that is designed to investigate the effectiveness of a multi-component intervention on improving fruit and vegetable consumption in teenagers and their mothers.
Read the detailed description
This study is a longitudinal controlled trial that is designed to investigate the effectiveness of a multi-component intervention on improving fruit and vegetable consumption in teenagers and their mothers. Participants will be allocated in three groups with a) an intervention group in which mothers and children receive the intervention and questionnaires, b) only the children receive the intervention and mothers and children receive the questionnaires, and c) mothers and children are in active control group and only receive the questionnaires. The intervention package contains behavior change techniques targeting outcome expectancy, self-efficacy, action planning, coping planning, and self-monitoring. The active control group receives an information sheet regarding recommendations on fruit and vegetable intake. There will be 3 assessment points in time, with 1 months in between. All the intervention materials and information sheets will be handed to participants after the baseline assessment. The self-monitoring calendar will be collected at time 2 assessment.
The primary outcome of this study is to estimate the dyadic mechanisms between mothers and their children regarding improving fruit and vegetable intake. Secondary outcome is to investigate whether fruit and vegetable consumption did improve in the intervention groups in general and also to find the psychological mechanism behind the changes during the time of the study.
- Conditions
- Nutrition
- Being tested
- behavioral, primary eduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioralBehavioural
The intervention package contains behavior change techniques targeting outcome expectancy, self-efficacy, action planning, coping planning, and self-monitoring. The active control group receives an information sheet regarding recommendations on fruit and vegetable intake. There will be 3 assessment points in time, with 1 month and six months in between. All the intervention materials and information sheets will be handed to participants after the baseline assessment. The self-monitoring calendar will be collected at time 2 assessment.
behavioralBehavioural
The intervention package contains behavior change techniques targeting outcome expectancy, self-efficacy, action planning, coping planning, and self-monitoring. The active control group receives an information sheet regarding recommendations on fruit and vegetable intake. There will be 3 assessment points in time, with 1 month and six months in between. All the intervention materials and information sheets will be handed to participants after the baseline assessment. The self-monitoring calendar will be collected at time 2 assessment.
primary eductionBehavioural
The intervention package contains behavior change techniques targeting outcome expectancy, self-efficacy, action planning, coping planning, and self-monitoring. The active control group receives an information sheet regarding recommendations on fruit and vegetable intake. There will be 3 assessment points in time, with 1 1 month and six months in between. All the intervention materials and information sheets will be handed to participants after the baseline assessment. The self-monitoring calendar will be collected at time 2 assessment.
| Study group | Role | What they receive |
|---|---|---|
| active control | Active comparator | mothers and children are in active control group and only receive the questionnaires Receives: Behavioral: primary eduction |
| mother and student | Experimental | an intervention group in which mothers and children receive the intervention and questionnaires Receives: Behavioral: behavioral |
| children | Experimental | only the children receive the intervention and mothers and children receive the questionnaires Receives: Behavioral: behavioral |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in fruit intake using a self-reported questionnaire
using a self-reported questionnaire
Measured: baseline, 1 Months, 6 months follow-up
changes in vegetable intake using a self-reported questionnaire
using a self-reported questionnaire
Measured: baseline, 1 Months, 6 months follow-up
Secondary outcomes (5)
changes in self efficacy using a self-reported questionnaire
using a self-reported questionnaire
Measured: baseline, 1 Months, 6 months follow-up
changes in outcome expectancy using a self-reported questionnaire
using a self-reported questionnaire
Measured: baseline, 1 Months, 6 months follow-up
changes in coping planning using a self-reported questionnaire
using a self-reported questionnaire
Measured: baseline, 1 Months, 6 months follow-up
changes in action planning using a self-reported questionnaire
using a self-reported questionnaire
Measured: baseline, 1 Months, 6 months follow-up
changes in self-monitoring using a self-reported questionnaire
using a self-reported questionnaire
Measured: baseline, 1 Months, 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir H Pakpour, Qazvin University Of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405611
- Sponsor's protocol ID
- 682
- Status last verified
- Jul 2016
- First submitted
- 25 Mar 2015
- Last updated
- 25 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-component Intervention on Improving Fruit and Vegetable Consumption in Teenagers and Their Mothers
- ClinicalTrials.gov ID
- NCT02405611
- Acronym / sponsor ID
- 682
- Conditions
- Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 Apr 2015 (estimated)
- 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 is a longitudinal controlled trial that is designed to investigate the effectiveness of a multi-component intervention on improving fruit and vegetable consumption in teenagers and their mothers.
Detailed description
This study is a longitudinal controlled trial that is designed to investigate the effectiveness of a multi-component intervention on improving fruit and vegetable consumption in teenagers and their mothers. Participants will be allocated in three groups with a) an intervention group in which mothers and children receive the intervention and questionnaires, b) only the children receive the intervention and mothers and children receive the questionnaires, and c) mothers and children are in active control group and only receive the questionnaires. The intervention package contains behavior change techniques targeting outcome expectancy, self-efficacy, action planning, coping planning, and self-monitoring. The active control group receives an information sheet regarding recommendations on fruit and vegetable intake. There will be 3 assessment points in time, with 1 months in between. All the intervention materials and information sheets will be handed to participants after the baseline assessment. The self-monitoring calendar will be collected at time 2 assessment.
The primary outcome of this study is to estimate the dyadic mechanisms between mothers and their children regarding improving fruit and vegetable intake. Secondary outcome is to investigate whether fruit and vegetable consumption did improve in the intervention groups in general and also to find the psychological mechanism behind the changes during the time of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| active control | Active comparator | Behavioral: primary eductionmothers and children are in active control group and only receive the questionnaires |
| mother and student | Experimental | Behavioral: behavioralan intervention group in which mothers and children receive the intervention and questionnaires |
| children | Experimental | Behavioral: behavioralonly the children receive the intervention and mothers and children receive the questionnaires |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- They are not involved in the nutritional education
- Ability to understand Persian language Adolescents attending high schools in Qazvin
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria
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 |
|---|---|---|
| behavioralThe intervention package contains behavior change techniques targeting outcome expectancy, self-efficacy, action planning, coping planning, and self-monitoring. The active control group receives an information sheet regarding recommendations on fruit and vegetable intake. There will be 3 assessment points in time, with 1 month and six months in between. All the intervention materials and information sheets will be handed to participants after the baseline assessment. The self-monitoring calendar will be collected at time 2 assessment. | Behavioural | mother and student |
| behavioralThe intervention package contains behavior change techniques targeting outcome expectancy, self-efficacy, action planning, coping planning, and self-monitoring. The active control group receives an information sheet regarding recommendations on fruit and vegetable intake. There will be 3 assessment points in time, with 1 month and six months in between. All the intervention materials and information sheets will be handed to participants after the baseline assessment. The self-monitoring calendar will be collected at time 2 assessment. | Behavioural | children |
| primary eductionThe intervention package contains behavior change techniques targeting outcome expectancy, self-efficacy, action planning, coping planning, and self-monitoring. The active control group receives an information sheet regarding recommendations on fruit and vegetable intake. There will be 3 assessment points in time, with 1 1 month and six months in between. All the intervention materials and information sheets will be handed to participants after the baseline assessment. The self-monitoring calendar will be collected at time 2 assessment. | Behavioural | active control |
Primary outcome
changes in fruit intake using a self-reported questionnaire
Time frame: baseline, 1 Months, 6 months follow-up
using a self-reported questionnaire
changes in vegetable intake using a self-reported questionnaire
Time frame: baseline, 1 Months, 6 months follow-up
using a self-reported questionnaire
5 secondary outcomes
changes in self efficacy using a self-reported questionnaire
Time frame: baseline, 1 Months, 6 months follow-up
changes in outcome expectancy using a self-reported questionnaire
Time frame: baseline, 1 Months, 6 months follow-up
changes in coping planning using a self-reported questionnaire
Time frame: baseline, 1 Months, 6 months follow-up
changes in action planning using a self-reported questionnaire
Time frame: baseline, 1 Months, 6 months follow-up
changes in self-monitoring using a self-reported questionnaire
Time frame: baseline, 1 Months, 6 months follow-up
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 25 Jul 2016.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral and primary eduction in people with Nutrition, run by Qazvin University Of Medical Sciences at 2 sites 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 2 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 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
changes in fruit intake using a self-reported questionnaire (time frame: baseline, 1 Months, 6 months follow-up). 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 25 Jul 2016.