Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes

Not Applicable

Completed

Conditions: Obesity
Overweight

Interventions: Behavioral: Health Coaching

Registration Number: NCT02124460

Lead Sponsor: Massachusetts General Hospital

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 Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity.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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 721

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health Coaching	Health Coaching	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.

Primary Outcome Measures

Name	Time	Method
Change in BMI z Score	baseline and one year	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.
Change in Quality of Life	baseline and one year	The PedsQL is an extensively validated, widely used, 23-item measure of health-related quality of life in children with chronic conditions such as obesity. Parents will be asked to complete 4 subscales: physical health, school, social, and emotional functioning which exists for parental report of children as young as 2 years of age. Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better HRQOL. Scale Scores are computed as the sum of the items divided by the number of items answered (this accounts for missing data). If more than 50% of the items in the scale are missing, the Scale Score is not computed.
Change in Parent Resource Empowerment	Baseline to one-year follow-up	The five items in the scale assessed parents' perceived knowledge of resources, ability to access resources, comfort with accessing resources, knowledge of how to find resources, and ability to acquire resources related to child weight management. For each question, parents responded strongly disagree, disagree, agree, or strongly agree, which were worth 1 to 4 points, respectively. Items were averaged to create a summary parental resource empowerment score (range= 1-4), where a higher score indicated greater perceived knowledge and ability to access resources related to weight management. Cronbach's α for this score was 0.87.

Secondary Outcome Measures

Name	Time	Method
Change in Sleep	baseline and 1 year	Average hours/day spent sleeping
Change in Fruit and Vegetable Consumption	baseline and 1 year	Number of times the child consumed of vegetables and fruits yesterday
Change in Consumption of Sugar-sweetened Beverages and Juice	baseline and 1 year	Number of time child consumed juice (e.g., orange juice, apple juice, or grape juice), fruit-flavored drinks (e.g., Kool-Aid, sports drinks, Goya juice, etc.), regular soda, soft drinks, or Malta yesterday.
Change in Screen Time	baseline and one year	Average hours/day spent watching television, videos, or playing games displayed on media such as television, desktop computers, laptops, portable DVD players, iPads or smartphones.
Change in Physical Activity	baseline and 1 year	In the past week, how many days the child was physically active for a total of at least 60 minutes per day.