This trial is active, not recruiting.

Conditions overweight, obesity
Treatment connect 4 health: using health coaches for behavioral counselling and community connections
Sponsor Massachusetts General Hospital
Collaborator Harvard Vanguard Medical Associates
Start date June 2014
End date June 2016
Trial size 721 participants
Trial identifier NCT02124460, IH-1304-6739


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 Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity.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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
(No Intervention)
We will provide current "best practice" to the control arm. 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.
The intervention for this study will consist of three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
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.

Primary Outcomes

time frame: one year
Quality of Life
time frame: one year

Secondary Outcomes

Quality and Family-Centeredness of Pediatric Obesity Care
time frame: One year
Pediatric Obesity Healthcare Effectiveness Data and Information Set (HEDIS) measures
time frame: one year
Specified behavioral outcomes
time frame: one year
Process measures
time frame: one year
Socioeconomic Variables
time frame: one year
Geographic variables
time frame: one year

Eligibility Criteria

Male or female participants from 2 years up to 12 years old.

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.

Additional Information

Official title Improving Childhood Obesity Outcomes: Testing Best Practices of Positive Outliers
Principal investigator Elsie M Taveras, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.