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N/A N=721 Randomized Single-blind Treatment

Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes

Overweight · Obesity

Enrolled (actual)
721
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Change in BMI z Score — -0.06; -0.09 BMI z score units — p=0.3928

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Health Coaching (Behavioral)
Age
Pediatric · 2+ yrs
Sex
All
Sponsor
Massachusetts General Hospital
Primary completion
Jun 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in BMI z Score
-0.06; -0.09 0.3928
PRIMARY
Change in Quality of Life
0.65; 1.53 0.2306
PRIMARY
Change in Parent Resource Empowerment
0.29; 0.22 .14
SECONDARY
Change in Screen Time
-0.06; -0.56 0.0016 sig
SECONDARY
Change in Sleep
-0.02; 0.40 <.0001 sig
SECONDARY
Change in Physical Activity
0.15; 0.33 0.3043
SECONDARY
Change in Fruit and Vegetable Consumption
0.19; 0.50 0.0113 sig
SECONDARY
Change in Consumption of Sugar-sweetened Beverages and Juice
-0.03; -0.25 0.0792

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 Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity.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

Eligibility Criteria

Inclusion Criteria

  • child is age 2.0 through 12.9 years at baseline primary care visit,
  • child's BMI is equal to or exceeds the 85th percentile for age and sex at baseline primary care visit,
  • at least 1 parent has an active email address,
  • at least one parent is comfortable reading and speaking in English.

Exclusion Criteria

  • children who do not have at least one parent/legal guardian who is able to follow study procedures for 1 year,
  • families who plan to leave HVMA within the study time frame,
  • families for whom the primary care clinician thinks the intervention is inappropriate, e.g., emotional or cognitive difficulties,
  • children who have a sibling already enrolled in the study,
  • children with chronic conditions that substantially interfere with growth or physical activity participation.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02124460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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