Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes

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 Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity.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

Conditions

• Overweight
• Obesity

Interventions

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.

Sponsors & Collaborators

• Harvard Vanguard Medical Associates

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Elsie M Taveras, MD, MPH · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-06-30

Primary Completion

2016-06-30

Completion

2016-11-30

Countries

• United States

Study Locations