Obesity Clinical Trial - Connect 4 Health: An Intervention to Improve

Status Active, not recruiting

Clinical Trial 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 Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity.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

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02124460
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Active, not recruiting
Phase	N/A
Start date	June 2014
Completion date	November 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms