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Completed

NCT Number: NCT02124460

Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes

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 Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity.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

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harvard Vanguard Medical Associates

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Health Coaching

Behavioral

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

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. Change in Sleep

    Time frame: baseline and 1 year

    Average hours/day spent sleeping

  3. 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.

  4. Change in Fruit and Vegetable Consumption

    Time frame: baseline and 1 year

    Number of times the child consumed of vegetables and fruits yesterday

  5. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Brigham and Women's Hospital
  • Harvard Vanguard Medical Associates

Registry information

Official study title

Improving Childhood Obesity Outcomes: Testing Best Practices of Positive Outliers

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 28, 2014
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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