Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-03-13 @ 3:55 PM
Study NCT ID:
NCT02124460
Status:
COMPLETED
Last Update Posted:
2017-04-10
First Post:
2014-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Improving Childhood Obesity Outcomes: Testing Best Practices of Positive Outliers
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Health care system (HCS)-based interventions have been limited by their inattention to social and environmental barriers that impede improvement in obesity-related behaviors. Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity. HCSs often lack the organizational structure to provide longitudinal care for children with chronic illnesses, the clinicians to manage and support patients with chronic illnesses outside of clinic, and/or the health information systems that support the use of evidence-based practices at the point-of-care. Thus, the research question this study is designed to address is whether a novel approach to care delivery that leverages delivery system and community resources and addresses socio-contextual factors will improve family-centered childhood obesity outcomes.
The primary specific aims are to examine the extent to which the intervention, compared to the control condition, results in:
1. A smaller age-associated increase in BMI over a 12-month period.
2. Improved parental and child ratings of pediatric health-related quality of life.
The secondary aims are:
1. To examine parental ratings of quality and family-centeredness of pediatric obesity care and compare outcomes among participants in the intervention with the control condition
2. To assess change in weight-related behaviors and compare outcomes among participants in the intervention with the control condition
3. To assess the following process measures:
* Reach
* Extent of implementation
* Fidelity to protocol
* Parent satisfaction
4. To examine the extent to which neighborhood environments modify observed intervention effects
5. To assess the documentation of Healthcare Effectiveness Data and Information Set (HEDIS) measures in participant medical records
The primary specific aims are to examine the extent to which the intervention, compared to the control condition, results in:
1. A smaller age-associated increase in BMI over a 12-month period.
2. Improved parental and child ratings of pediatric health-related quality of life.
The secondary aims are:
1. To examine parental ratings of quality and family-centeredness of pediatric obesity care and compare outcomes among participants in the intervention with the control condition
2. To assess change in weight-related behaviors and compare outcomes among participants in the intervention with the control condition
3. To assess the following process measures:
* Reach
* Extent of implementation
* Fidelity to protocol
* Parent satisfaction
4. To examine the extent to which neighborhood environments modify observed intervention effects
5. To assess the documentation of Healthcare Effectiveness Data and Information Set (HEDIS) measures in participant medical records
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: