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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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.

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 Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity.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

Primary Outcome

Height and weight will be measured by the medical assistants at each site using standard protocols. BMI measures will be obtained from the electronic health record (EHR) as provided through usual care. BMI measures will be converted to z-scores using CDC age and sex-specific normative data for children between 2 and 20 years old. This will allow the research team to combine data across children of different ages.

Interventions

  • BEHAVIORAL Health Coaching

Trial Details

FieldValue
Enrollment Target 721 participants
Start Date 2014-06
Est. Completion 2016-11
Phase NA
Massachusetts General Hospital

2,032 total trials

What the finished NCT02124460 record still lists

NCT02124460 is an interventional study that assigns participants to a tested intervention. The registered 721 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (49% lower).

The record links to 0 conditions, and to 1 intervention - of which Health Coaching is the first listed.

NCT02124460 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02124460's enrollment target sits among peer trials

721 146th of 2000 higher than 1,855 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02124460, the US trial registry maintained by the National Library of Medicine. NCT02124460 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.