- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02405611
A Multi-component Intervention on Improving Fruit and Vegetable Consumption in Teenagers and Their Mothers
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Qazvin, Iran, Islamic Republic of
- The Organization for Education
-
Qazvin, Iran, Islamic Republic of, 3419759811
- Department of Public Health, Qazvin University of Medical Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- They are not involved in the nutritional education
- Ability to understand Persian language Adolescents attending high schools in Qazvin
Exclusion Criteria:
- Does not meet inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: active control
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 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.
|
Experimental: mother and student
an intervention group in which mothers and children receive the intervention and 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 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.
|
Experimental: children
only the children receive the intervention and mothers and children 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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in fruit intake using a self-reported questionnaire
Time Frame: baseline, 1 Months, 6 months follow-up
|
using a self-reported questionnaire
|
baseline, 1 Months, 6 months follow-up
|
changes in vegetable intake using a self-reported questionnaire
Time Frame: baseline, 1 Months, 6 months follow-up
|
using a self-reported questionnaire
|
baseline, 1 Months, 6 months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in self efficacy using a self-reported questionnaire
Time Frame: baseline, 1 Months, 6 months follow-up
|
using a self-reported questionnaire
|
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
|
using a self-reported questionnaire
|
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
|
using a self-reported questionnaire
|
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
|
using a self-reported questionnaire
|
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
|
using a self-reported questionnaire
|
baseline, 1 Months, 6 months follow-up
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 682
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