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NCT02124460 · ClinicalTrials.gov registry record · NA
Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 721
- Enrollment target
NCT02124460: Completed NA study, sponsored by Massachusetts General Hospital.
NCT02124460 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 721 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02124460, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 721 participants
- Enrollment target
Study 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 Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity.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
Interventions
- BEHAVIORAL Health Coaching
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 721 participants |
| Start Date | 2014-06 |
| Est. Completion | 2016-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02124460
The ClinicalTrials.gov registry entry for NCT02124460 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 721 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Health Coaching is the first listed.
NCT02124460 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02124460 about?
NCT02124460 is a clinical study titled "Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes". 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...
What is the current status of trial NCT02124460?
This trial is currently completed. It is a NA study. The enrollment target is 721 participants. The study started on 2014-06. Estimated completion is 2016-11.
What interventions are being tested in trial NCT02124460?
The interventions under investigation include: Health Coaching (BEHAVIORAL).
Who is sponsoring clinical trial NCT02124460?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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