NCT02912000

Brief Summary

The proposed study is a pre- /post-implementation study in a pediatric practice with a control practice designed to test the feasibility and effectiveness of an electronic screening and service delivery tool for three modifiable health risk factors in pediatrics: parental tobacco use, sugar-sweetened beverages consumption, and poor dental care

Trial Health

87
On Track

Trial Health Score

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

Enrollment
650

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

6 months

First QC Date

September 21, 2016

Last Update Submit

March 20, 2018

Conditions

Keywords

Dental Health ServicesSugar-Sweetened BeveragesTobacco controlPediatricsParents

Outcome Measures

Primary Outcomes (1)

  • Reported screening and counseling by physicians about parental smoking, child dentist appointment, and sugar-sweetened beverages

    Higher rates of screening, counseling, and service delivery by clinicians in the period after implementation than at baseline (pre-implementation).

    Pre-implementation (baseline) and Post-implementation

Secondary Outcomes (2)

  • Parent report of behavior change intention related to parental smoking, child sugar sweetened beverage consumption and child's dental appointment

    At baseline and one month follow-up

  • Reported behavior change related to parental smoking, child sugar sweetened beverage consumption and child's dental appointment

    one month follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will receive the TEACH intervention - an electronic tablet screening in waiting room for the modifiable risk factors

Behavioral: TEACH intervention

Control

NO INTERVENTION

Care as usual: No electronic tablet in waiting room

Interventions

The TEACH intervention screens family for three modifiable behaviors ahead of the clinical encounter: parental tobacco use, children consumption of sugar-sweetened beverages and child dental health. The information from the screening is then shared with clinicians.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parent of a child aged 0-18 years

You may not qualify if:

  • Parents under age 18
  • Parents who have a child with a medical emergency (any condition requiring transfer for immediate medical intervention)
  • Non-consenting individuals
  • Non-English speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

SmokingObesityDental Caries

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsTooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Jonathan P Winickoff, MD MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 21, 2016

First Posted

September 23, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations