Clinical trial NCT02124460: Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes
Official title: Improving Childhood Obesity Outcomes: Testing Best Practices of Positive Outliers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Pediatric
Obesity
Overweight
Intervention
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Harvard Vanguard Medical Associates
name: Brigham and Women's Hospital
First posted: 2014-04-28
Enrollment: 721
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity.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


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.

Primary outcomes:
measure: Change in BMI z Score
timeFrame: baseline and one year
measure: Change in Quality of Life
timeFrame: baseline and one year
measure: Change in Parent Resource Empowerment
timeFrame: Baseline to one-year follow-up
Secondary outcomes:
measure: Change in Screen Time
timeFrame: baseline and one year
measure: Change in Sleep
timeFrame: baseline and 1 year
measure: Change in Physical Activity
timeFrame: baseline and 1 year
measure: Change in Fruit and Vegetable Consumption
timeFrame: baseline and 1 year
measure: Change in Consumption of Sugar-sweetened Beverages and Juice
timeFrame: baseline and 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard Vanguard Medical Associates
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Elsie M Taveras, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simione M, Sharifi M, Gerber MW, Marshall R, Avalon E, Fiechtner L, Horan C, Orav EJ, Skelton J, Taveras EM. Family-centeredness of childhood obesity interventions: psychometrics & outcomes of the family-centered care assessment tool. Health Qual Life Outcomes. 2020 Jun 11;18(1):179. doi: 10.1186/s12955-020-01431-y.
citation: Baskind MJ, Taveras EM, Gerber MW, Fiechtner L, Horan C, Sharifi M. Parent-Perceived Stress and Its Association With Children's Weight and Obesity-Related Behaviors. Prev Chronic Dis. 2019 Mar 28;16:E39. doi: 10.5888/pcd16.180368.
citation: Bala N, Price SN, Horan CM, Gerber MW, Taveras EM. Use of Telehealth to Enhance Care in a Family-Centered Childhood Obesity Intervention. Clin Pediatr (Phila). 2019 Jun;58(7):789-797. doi: 10.1177/0009922819837371. Epub 2019 Mar 20.
citation: Fiechtner L, Puente GC, Sharifi M, Block JP, Price S, Marshall R, Blossom J, Gerber MW, Taveras EM. A Community Resource Map to Support Clinical-Community Linkages in a Randomized Controlled Trial of Childhood Obesity, Eastern Massachusetts, 2014-2016. Prev Chronic Dis. 2017 Jul 6;14:E53. doi: 10.5888/pcd14.160577.
citation: Taveras EM, Marshall R, Sharifi M, Avalon E, Fiechtner L, Horan C, Gerber MW, Orav EJ, Price SN, Sequist T, Slater D. Comparative Effectiveness of Clinical-Community Childhood Obesity Interventions: A Randomized Clinical Trial. JAMA Pediatr. 2017 Aug 7;171(8):e171325. doi: 10.1001/jamapediatrics.2017.1325. Epub 2017 Aug 7.
citation: Taveras EM, Marshall R, Sharifi M, Avalon E, Fiechtner L, Horan C, Orav J, Price SN, Sequist T, Slater D. Connect for Health: Design of a clinical-community childhood obesity intervention testing best practices of positive outliers. Contemp Clin Trials. 2015 Nov;45(Pt B):287-295. doi: 10.1016/j.cct.2015.09.022. Epub 2015 Sep 30.