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Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02124460
Recruitment Status : Completed
First Posted : April 28, 2014
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Collaborators:
Harvard Vanguard Medical Associates
Brigham and Women's Hospital
Information provided by (Responsible Party):
Elsie Taveras, MD, Massachusetts General Hospital

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 Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity.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

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: Health Coaching Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 721 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Childhood Obesity Outcomes: Testing Best Practices of Positive Outliers
Study Start Date : June 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
No Intervention: Enhanced Primary Care
We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. 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.
Experimental: Health Coaching
The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
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.





Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02124460


Locations
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United States, Massachusetts
Harvard Vanguard Medical Associates
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Massachusetts General Hospital
Harvard Vanguard Medical Associates
Brigham and Women's Hospital
Investigators
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Principal Investigator: Elsie M Taveras, MD, MPH Massachusetts General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Elsie Taveras, MD, Chief, Division of General Academic Pediatrics, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02124460    
Other Study ID Numbers: IH-1304-6739
First Posted: April 28, 2014    Key Record Dates
Results First Posted: April 10, 2017
Last Update Posted: April 10, 2017
Last Verified: February 2017
Keywords provided by Elsie Taveras, MD, Massachusetts General Hospital:
Pediatric
Obesity
Overweight
Intervention
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms