Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes

NCT02124460 | Completed Results

• 1 other identifier: IH-1304-6739
• Study Type: interventional
• Target: 721
• Locations: 1 country
• Sites: 1

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 Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity.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

• Reach
• Extent of implementation
• Fidelity to protocol
• Parent satisfaction
• To examine the extent to which neighborhood environments modify observed intervention effects
• To assess the documentation of Healthcare Effectiveness Data and Information Set (HEDIS) measures in participant medical records

Conditions

Overweight; Obesity

Keywords

Pediatric; Obesity; Overweight; Intervention

Outcome Measures

Primary Outcomes (3)

• Change in BMI z Score

  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.

  baseline and one year

• Change in Quality of Life

  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.

  baseline and one year

• Change in Parent Resource Empowerment

  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.

  Baseline to one-year follow-up

Secondary Outcomes (5)

• Change in Screen Time

  baseline and one year

• Change in Sleep

  baseline and 1 year

• Change in Physical Activity

  baseline and 1 year

• Change in Fruit and Vegetable Consumption

  baseline and 1 year

• Change in Consumption of Sugar-sweetened Beverages and Juice

  baseline and 1 year

Study Arms (2)

Enhanced Primary Care

NO INTERVENTION

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.

Health Coaching

EXPERIMENTAL

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

Interventions

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.

Health Coaching

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Harvard Vanguard Medical Associates: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Harvard Vanguard Medical Associates

Boston, Massachusetts, 02215, United States

Location

Related Publications (8)

• Simione M, Ferreira P, Luo M, Hoover C, Perkins M, Fiechtner L, Taveras EM. Psychometrics of the modified family-centered care assessment short version for childhood obesity. Health Qual Life Outcomes. 2024 Sep 2;22(1):71. doi: 10.1186/s12955-024-02284-5.

  PMID: 39218948 DERIVED

• Simione M, Ferreira P, Luo M, Hoover C, Perkins M, Fiechtner L, Taveras EM. Psychometrics of the modified Family-Centered Care Assessment short version for childhood obesity. Res Sq [Preprint]. 2024 May 15:rs.3.rs-4365570. doi: 10.21203/rs.3.rs-4365570/v1.

  PMID: 38798356 DERIVED

• Simione M, Sharifi M, Gerber MW, Marshall R, Avalon E, Fiechtner L, Horan C, Orav EJ, Skelton J, Taveras EM. Family-centeredness of childhood obesity interventions: psychometrics & outcomes of the family-centered care assessment tool. Health Qual Life Outcomes. 2020 Jun 11;18(1):179. doi: 10.1186/s12955-020-01431-y.

  PMID: 32527270 DERIVED

• Baskind MJ, Taveras EM, Gerber MW, Fiechtner L, Horan C, Sharifi M. Parent-Perceived Stress and Its Association With Children's Weight and Obesity-Related Behaviors. Prev Chronic Dis. 2019 Mar 28;16:E39. doi: 10.5888/pcd16.180368.

  PMID: 30925139 DERIVED

• Bala N, Price SN, Horan CM, Gerber MW, Taveras EM. Use of Telehealth to Enhance Care in a Family-Centered Childhood Obesity Intervention. Clin Pediatr (Phila). 2019 Jun;58(7):789-797. doi: 10.1177/0009922819837371. Epub 2019 Mar 20.

  PMID: 30894004 DERIVED

• Fiechtner L, Puente GC, Sharifi M, Block JP, Price S, Marshall R, Blossom J, Gerber MW, Taveras EM. A Community Resource Map to Support Clinical-Community Linkages in a Randomized Controlled Trial of Childhood Obesity, Eastern Massachusetts, 2014-2016. Prev Chronic Dis. 2017 Jul 6;14:E53. doi: 10.5888/pcd14.160577.

  PMID: 28682745 DERIVED

• Taveras EM, Marshall R, Sharifi M, Avalon E, Fiechtner L, Horan C, Gerber MW, Orav EJ, Price SN, Sequist T, Slater D. Comparative Effectiveness of Clinical-Community Childhood Obesity Interventions: A Randomized Clinical Trial. JAMA Pediatr. 2017 Aug 7;171(8):e171325. doi: 10.1001/jamapediatrics.2017.1325. Epub 2017 Aug 7.

  PMID: 28586856 DERIVED

• Taveras EM, Marshall R, Sharifi M, Avalon E, Fiechtner L, Horan C, Orav J, Price SN, Sequist T, Slater D. Connect for Health: Design of a clinical-community childhood obesity intervention testing best practices of positive outliers. Contemp Clin Trials. 2015 Nov;45(Pt B):287-295. doi: 10.1016/j.cct.2015.09.022. Epub 2015 Sep 30.

  PMID: 26427562 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Elsie Taveras
• Organization: Massachusetts General Hospital

elsie.taveras@mgh.harard.edu

617-726-8555

Study Officials

• Elsie M Taveras, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of General Academic Pediatrics

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 28, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 10, 2017
• Results First Posted: April 10, 2017

Record last verified: 2017-02

Locations

US (1)