NCT02405611

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 25, 2016

Status Verified

July 1, 2016

Enrollment Period

9 months

First QC Date

March 25, 2015

Last Update Submit

July 22, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • changes in fruit intake using a self-reported questionnaire

    using a self-reported questionnaire

    baseline, 1 Months, 6 months follow-up

  • changes in vegetable intake using a self-reported questionnaire

    using a self-reported questionnaire

    baseline, 1 Months, 6 months follow-up

Secondary Outcomes (5)

  • changes in self efficacy using a self-reported questionnaire

    baseline, 1 Months, 6 months follow-up

  • changes in outcome expectancy using a self-reported questionnaire

    baseline, 1 Months, 6 months follow-up

  • changes in coping planning using a self-reported questionnaire

    baseline, 1 Months, 6 months follow-up

  • changes in action planning using a self-reported questionnaire

    baseline, 1 Months, 6 months follow-up

  • changes in self-monitoring using a self-reported questionnaire

    baseline, 1 Months, 6 months follow-up

Study Arms (3)

active control

ACTIVE COMPARATOR

mothers and children are in active control group and only receive the questionnaires

Behavioral: primary eduction

mother and student

EXPERIMENTAL

an intervention group in which mothers and children receive the intervention and questionnaires

Behavioral: behavioral

children

EXPERIMENTAL

only the children receive the intervention and mothers and children receive the questionnaires

Behavioral: behavioral

Interventions

behavioralBEHAVIORAL

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.

mother and student

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.

active control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • They are not involved in the nutritional education
  • Ability to understand Persian language Adolescents attending high schools in Qazvin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Public Health, Qazvin University of Medical Sciences

Qazvin, Qazvin Province, 3419759811, Iran

Location

The Organization for Education

Qazvin, Qazvin Province, Iran

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Public Health, Qazvin University of Medical Sciences, Qazvin, Iran.

Study Record Dates

First Submitted

March 25, 2015

First Posted

April 1, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

July 25, 2016

Record last verified: 2016-07

Locations