Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes

Obesity Clinical Trial

Official title:

Improving Childhood Obesity Outcomes: Testing Best Practices of Positive Outliers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02124460
• Other study ID #: IH-1304-6739
• Status: Active, not recruiting
• Phase: N/A
• First received: April 14, 2014
• Last updated: September 12, 2016
• Start date: June 2014
• Est. completion date: November 2016

Study information

• Verified date: September 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Patient Centered Outcomes Research Institute
• Study type: Interventional

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 Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity.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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 721
• Est. completion date: November 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight
• Pediatric Obesity

Intervention

Behavioral:
• Connect 4 Health: Using Health Coaches for Behavioral Counselling and Community Connections
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.

Locations

Country	Name	City	State
United States	Harvard Vanguard Medical Associates	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brigham and Women's Hospital, Harvard Vanguard Medical Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI	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.	one year	No
Primary	Quality of Life	Parents will be asked to complete the PedsQL-4.0 for their child. The PedsQL is an extensively validated, widely used, 23-item measure of health-related quality of life in children. It has been used to assess quality of life of 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. In addition, investigators will assess child-report of quality of life using the child version of the PedsQL validated among children ages 8 and over. The research team will also assess frequency of bullying and teasing, exercise intolerance, and satisfaction with clothing size.	one year	No
Secondary	Quality and Family-Centeredness of Pediatric Obesity Care		One year	No
Secondary	Pediatric Obesity Healthcare Effectiveness Data and Information Set (HEDIS) measures	Pediatric Obesity Healthcare Effectiveness Data and Information Set (HEDIS) measures, such as weight-related diagnosis, nutrition and physical activity counselling, from the participants' EHRs	one year	No
Secondary	Specified behavioral outcomes	Screentime, Physical Activity, Sleep Duration, Diet (Sugar-sweetened beverage intake, Fruits and Vegetables, Snacks and treat foods, Fast food intake)	one year	No
Secondary	Process measures	Information will be collected on the acceptability, feasibility, uptake of components of the intervention, and family engagement in the study from the parents' perspectives. The following implementation domains will be measured at 12 months: a) reach, b) extent of implementation, c) fidelity to protocol, and d) parent satisfaction with multiple dimensions of care.	one year	No
Secondary	Socioeconomic Variables	Investigators will measure variables that can act as effect modifiers or confounders of intervention effects including: (a) Indicators of socioeconomic status and (b) parental characteristics: age, height and weight, and marital status.	one year	No
Secondary	Geographic variables	The extent to which neighborhood environments modify any observed intervention effects will be examined.	one year	No