NCT02575326

Brief Summary

Little guidance is given to physicians caring for obese adolescents with asthma, however, findings suggest that interventions designed to achieve asthma control in these patients are necessary. Because of the psychosocial factors often associated with obesity and asthma (e.g., low self-esteem, depression, and low quality of life) successful interventions should incorporate a patient-centered approach. The proposed study design is a clinic-based, randomized controlled trial (RCT) in teens with a history of asthma and who are overweight or obese.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable asthma

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

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

August 6, 2018

Status Verified

February 1, 2018

Enrollment Period

2.5 years

First QC Date

October 12, 2015

Last Update Submit

August 2, 2018

Conditions

AsthmaObesity

Keywords

Asthma, Body Mass Idex, BMI, Overweight, Obesity

Outcome Measures

Primary Outcomes (1)

  • Asthma Control Test

    A validated measure of asthma control

    12 months of enrollment

Secondary Outcomes (1)

  • Body Mass Index (BMI)

    12 months of enrollment

Study Arms (2)

Standard Control

OTHER

Teens in the control group will receive standard or usual care as provided by their physician.

Other: Standard Control

Intervention

OTHER

Teens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques.

Behavioral: a provider administered, tailored discussion guide

Interventions

Standard ControlOTHER

Teens in the control group will receive standard or usual care as provided by their physician.

Standard Control
a provider administered, tailored discussion guideBEHAVIORAL

Teens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques.

Intervention

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • BMI \>85th Percentile \& Diagnosed with asthma; using a modification of Healthcare Effectiveness Data and Information Set (HEDIS) criteria:
  • At least one emergency department visit with a principal diagnosis of asthma, or
  • At least one acute inpatient claim/encounter with asthma as the principal diagnosis or at least four outpatient visits with an asthma diagnosis and at least or
  • At least four asthma four outpatient visit with an asthma diagnosis and at least two asthma medications dispensed, or
  • At least four asthma medications dispensed in the last 12 month

You may not qualify if:

  • Does not meet eligibility criteria for weight and/or asthma;
  • Currently enrolled in another investigational asthma management /education/weight management trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford System

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

  • Joseph CLM, Alexander GL, Lu M, Leatherwood SL, Kado R, Olden H, Melkonian C, Miree CA, Johnson CC. Pilot study of a brief provider and EMR-based intervention for overweight teens with asthma. Pilot Feasibility Stud. 2021 Aug 30;7(1):167. doi: 10.1186/s40814-021-00848-6.

    PMID: 34462008DERIVED

MeSH Terms

Conditions

AsthmaObesityOverweight

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christine Joseph, PhD

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Physicians are randomized. Eligible youth that present to the participating physician assume the assignment of that physician
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Epidemiologist

Study Record Dates

First Submitted

October 12, 2015

First Posted

October 14, 2015

Study Start

August 1, 2015

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

August 6, 2018

Record last verified: 2018-02

Locations

US(1)