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Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes

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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

Tracking Information
First Submitted Date  ICMJE April 14, 2014
First Posted Date  ICMJE April 28, 2014
Results First Submitted Date  ICMJE October 28, 2016
Results First Posted Date  ICMJE April 10, 2017
Last Update Posted Date April 10, 2017
Study Start Date  ICMJE June 2014
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2017)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2014)
  • BMI [ Time Frame: 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.
  • Quality of Life [ Time Frame: one year ]
    Parents will be asked to complete the PedsQL-4.0 for their child. The PedsQL is an extensively validated, widely used, 23-item measure of health-related quality of life in children. It has been used to assess quality of life of 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. In addition, investigators will assess child-report of quality of life using the child version of the PedsQL validated among children ages 8 and over. The research team will also assess frequency of bullying and teasing, exercise intolerance, and satisfaction with clothing size.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2017)
  • 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.
  • Change in Sleep [ Time Frame: baseline and 1 year ]
    Average hours/day spent sleeping
  • 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.
  • Change in Fruit and Vegetable Consumption [ Time Frame: baseline and 1 year ]
    Number of times the child consumed of vegetables and fruits yesterday
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2014)
  • 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 ]
    Pediatric Obesity Healthcare Effectiveness Data and Information Set (HEDIS) measures, such as weight-related diagnosis, nutrition and physical activity counselling, from the participants' EHRs
  • Specified behavioral outcomes [ Time Frame: one year ]
    Screentime, Physical Activity, Sleep Duration, Diet (Sugar-sweetened beverage intake, Fruits and Vegetables, Snacks and treat foods, Fast food intake)
  • Process measures [ Time Frame: one year ]
    Information will be collected on the acceptability, feasibility, uptake of components of the intervention, and family engagement in the study from the parents' perspectives. The following implementation domains will be measured at 12 months: a) reach, b) extent of implementation, c) fidelity to protocol, and d) parent satisfaction with multiple dimensions of care.
  • Socioeconomic Variables [ Time Frame: one year ]
    Investigators will measure variables that can act as effect modifiers or confounders of intervention effects including: (a) Indicators of socioeconomic status and (b) parental characteristics: age, height and weight, and marital status.
  • Geographic variables [ Time Frame: one year ]
    The extent to which neighborhood environments modify any observed intervention effects will be examined.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes
Official Title  ICMJE Improving Childhood Obesity Outcomes: Testing Best Practices of Positive Outliers
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Overweight
  • Obesity
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Health Coaching
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2015)
721
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2014)
750
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02124460
Other Study ID Numbers  ICMJE IH-1304-6739
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elsie Taveras, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE
  • Harvard Vanguard Medical Associates
  • Brigham and Women's Hospital
Investigators  ICMJE
Principal Investigator: Elsie M Taveras, MD, MPH Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP