NCT02066987

Brief Summary

the present study had two main aims. First, due to the current underconsumption of dental brush adolescents, the investigators should apply a volitional intervention to increase oral health behvaiour in adolescents. Second, the investigators aim to compare the effectiveness of action planning intervention and implementation intention will improve oral health behavior in adolescents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,110

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 16, 2014

Status Verified

September 1, 2014

Enrollment Period

7 months

First QC Date

February 17, 2014

Last Update Submit

September 14, 2014

Conditions

Oral Health Behavior Change

Keywords

Action planning, Implementation intention

Outcome Measures

Primary Outcomes (1)

  • changes in frequencies of dental brushing

    changes from baseline, one month after the intervention and six months follow-up

Secondary Outcomes (5)

  • changes in psychological predictors of dental brushing (intention ,perceived behavioural control and Self-monitoring)

    changes from baseline, one month after the intervention and six months follow-up

  • Changes in Community Periodontal Index (CPI)

    changes from baseline, one month after the intervention and six months follow-up

  • Changes in Turesky Modification of the Quigley-Hein Plaque Index

    changes from baseline, one month after the intervention and six months follow-up

  • Oral health related quality of life

    changes from baseline and six months follow-up

  • The frequency of the use of planning

    changes from baseline, one month after the intervention and six months follow-up

Study Arms (3)

Implementation intention

EXPERIMENTAL

It may be helpful for you to plan when and where you will brush your teeth each day over the next month. Please write below when, where, and after what activity you will brush your teeth (e.g., at 8.00 a.m. and 9.00 p.m. in the bathroom after eating breakfast/dinner). Because you should brush your teeth twice a day, please make two plans. If it is \_\_\_\_\_ (WHEN) at or in \_\_\_\_\_\_\_ (WHERE) before/after \_\_\_\_\_\_ (ACTIVITY), then I will brush my teeth! If it is \_\_\_\_\_ (WHEN) at or in \_\_\_\_\_\_\_ (WHERE) before/after \_\_\_\_\_\_ (ACTIVITY), then I will brush my teeth!

Behavioral: Implementation intention

Action planning

EXPERIMENTAL

It may be helpful for you to plan when and where you will brush your teeth each day over the next month. Please write below when, where, and after what activity you will brush your teeth (e.g., at 8.00 a.m. and 9.00 p.m. in the bathroom after eating breakfast/dinner). Because you should brush your teeth twice a day, please make two plans. I will brush my teeth at \_\_\_(WHEN) at or in \_\_\_\_(WHERE) before/after \_\_\_ (ACTIVITY). I will brush my teeth at \_\_\_(WHEN) at or in \_\_\_\_(WHERE) before/after \_\_\_ (ACTIVITY).

Behavioral: Action planning

active control group

ACTIVE COMPARATOR

Participants in the active control group will receive an educational pamphlet containing what it is dental brushing, why it is done, and how it is done.

Behavioral: active control group

Interventions

Implementation intentionBEHAVIORAL

It may be helpful for you to plan when and where you will brush your teeth each day over the next month. Please write below when, where, and after what activity you will brush your teeth (e.g., at 8.00 a.m. and 9.00 p.m. in the bathroom after eating breakfast/dinner). Because you should brush your teeth twice a day, please make two plans. If it is \_\_\_\_\_ (WHEN) at or in \_\_\_\_\_\_\_ (WHERE) before/after \_\_\_\_\_\_ (ACTIVITY), then I will brush my teeth! If it is \_\_\_\_\_ (WHEN) at or in \_\_\_\_\_\_\_ (WHERE) before/after \_\_\_\_\_\_ (ACTIVITY), then I will brush my teeth!

Implementation intention
Action planningBEHAVIORAL

It may be helpful for you to plan when and where you will brush your teeth each day over the next month. Please write below when, where, and after what activity you will brush your teeth (e.g., at 8.00 a.m. and 9.00 p.m. in the bathroom after eating breakfast/dinner). Because you should brush your teeth twice a day, please make two plans. I will brush my teeth at \_\_\_(WHEN) at or in \_\_\_\_(WHERE) before/after \_\_\_ (ACTIVITY). I will brush my teeth at \_\_\_(WHEN) at or in \_\_\_\_(WHERE) before/after \_\_\_ (ACTIVITY).

Action planning
active control groupBEHAVIORAL

Participants in the active control group will receive an educational pamphlet containing what it is dental brushing, why it is done, and how it is done.

active control group

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Years to 19 Years
  • Ability to understand Persian language Adolescents attending high schools in Qazvin

You may not qualify if:

  • participate in any kind of oral health education and promotion programs
  • undergoing orthodontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Public Health, Qazvin University of Medical Sciences

Qazvin, Qazvin Province, 3419759811, Iran

Location

Related Publications (1)

  • Pakpour AH, Gholami M, Gellert P, Yekaninejad MS, Dombrowski SU, Webb TL. The Effects of Two Planning Interventions on the Oral Health Behavior of Iranian Adolescents: A Cluster Randomized Controlled Trial. Ann Behav Med. 2016 Jun;50(3):409-18. doi: 10.1007/s12160-015-9767-3.

    PMID: 26791023DERIVED

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Chancellor for Research

Study Record Dates

First Submitted

February 17, 2014

First Posted

February 20, 2014

Study Start

February 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 16, 2014

Record last verified: 2014-09

Locations

IR(1)