Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes

Mass General Brigham

Status: Completed

Conditions: Overweight; Obesity

Treatments: Behavioral: Health Coaching

Study type: Interventional

Funder types: Other

Identifiers

NCT02124460

IH-1304-6739

Details and patient eligibility

About

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 Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity.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

Enrollment: 721 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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721 participants in 2 patient groups

Enhanced Primary Care

No Intervention group

Description:

We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.

Health Coaching

Experimental group

Description:

The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.

Treatment:

Behavioral: Health Coaching