Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes
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|ClinicalTrials.gov Identifier: NCT02124460|
Recruitment Status : Completed
First Posted : April 28, 2014
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
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 Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity.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:
- A smaller age-associated increase in BMI over a 12-month period.
- Improved parental and child ratings of pediatric health-related quality of life.
The secondary aims are:
- 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
- To assess change in weight-related behaviors and compare outcomes among participants in the intervention with the control condition
To assess the following process measures:
- Extent of implementation
- Fidelity to protocol
- Parent satisfaction
- To examine the extent to which neighborhood environments modify observed intervention effects
- To assess the documentation of Healthcare Effectiveness Data and Information Set (HEDIS) measures in participant medical records
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity||Behavioral: Health Coaching||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||721 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Improving Childhood Obesity Outcomes: Testing Best Practices of Positive Outliers|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||November 2016|
No Intervention: Enhanced Primary Care
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.
Experimental: 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.
Behavioral: Health Coaching
Parent/child duos enrolled in the intervention group will participate in a total of six visits with a trained health coach. During these visits, the health coach will coach the parent/child duos on improving obesity-related behaviors .
The health coach will also help the family identify supports to assist with behavior change; discuss family health habits and the home environment; and review and encourage use of materials related to both specific target behaviors and available resources in the community.
Following the first call with the health coach, parents will receive semi-weekly text messages designed by the study team. The messages will alternate in structure between 2 types of messages; 1) skills training messages will deliver tips and motivational messages to help their child practice the study's goals and 2) self monitoring messages will ask parents to respond to the message and track health behaviors important to this study.
- Change in BMI z Score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Change in Screen Time [ Time Frame: 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 Sleep [ Time Frame: baseline and 1 year ]Average hours/day spent sleeping
- Change in Physical Activity [ Time Frame: 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.
- Change in Fruit and Vegetable Consumption [ Time Frame: baseline and 1 year ]Number of times the child consumed of vegetables and fruits yesterday
- Change in Consumption of Sugar-sweetened Beverages and Juice [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02124460
|United States, Massachusetts|
|Harvard Vanguard Medical Associates|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Elsie M Taveras, MD, MPH||Massachusetts General Hospital|