N/A
N=721
Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes
Overweight · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02124460 ↗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
| Outcome | Result | p-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 Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity.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.
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.