SBIR-STTR Award

Direct to Phase II

One in five youth in the US has obesity, which is associated with reduced quality of life and significant comorbidities, including what were once adult-onset diseases (e.g., Type 2 Diabetes). Effective treatments exist, such as Family-based Behavioral Treatment (FBT), an evidence-based intervention for children with obesity and their caregivers. However, treatments are not widely or equitably distributed; most youth with obesity do not receive effective care. Technology can be leveraged to bring pediatric obesity interventions into real-world practice, creating meaningful and sustainable public health impact by addressing barriers to treatment (e.g., lack of providers, logistical barriers). Digital support tools for the caregiver and youth would further facilitate effective implementation of the intervention by fostering learning and skill development, thereby increasing the scalability of evidence-based interventions without sacrificing fidelity. This SBIR aims to address gaps in treatment access by creating a digital training and delivery package for dissemination and implementation of FBT at scale. Through recently secured CDC funding, we have developed and tested a professional e-training platform for FBT. The primary goal of this SBIR Direct to Phase II is to expand upon the existing training platform to create an "all-in- one" digital product, FBT 2.0, that offers an integrated suite of intervention components, including (a) dynamic, personalized, self-paced program for children and parent/caregivers; (b) e-training and ongoing support for interventionists; and (c) family engagement and monitoring tools for interventionists. We will create a comprehensive, e-learning digital intervention with engaging, interactive, and personalized online tools for youth and their parents/caregivers that are integrated into the broader interventionist platform. A direct to Phase II was deemed appropriate given (1) FBT is an established and effective intervention in line with U. S. Preventive Services Task Force obesity-care recommendations, with an already developed digital training platform; (2) prior research demonstrating high usability and engagement of 3C Institute's proprietary dynamic e-learning platform for a broad array of end users; and (3) 3C's considerable experience developing, testing, and commercializing innovative e-learning software products. This SBIR Direct to Phase II project will accomplish three specific aims: (1) develop the full FBT 2.0 digital platform through iterative usability testing with twenty youth/caregiver dyads (i.e., youth aged 6-18 years of age with obesity and one parent/caregiver); (2) conduct a 6-month randomized controlled pilot trial with 70 youth/caregiver dyads to gather preliminary evidence of the efficacy of FBT 2.0 on relative weight, behavioral and psychosocial outcomes; (3) finalize and prepare FBT 2.0 for commercialization using data and feedback from the pilot trial, and feedback from focus groups conducted with stakeholders who are involved in the treatment of children with obesity (behavioral and medical health providers, clinic and health system leadership, payers). The resulting FBT 2.0 will transform evidence-based FBT into an effective, engaging, and scalable intervention for broad dissemination and sustainable public health impact.

Public Health Relevance Statement:
Narrative There is an urgent public health need to increase availability of and access to evidence-based treatments for childhood obesity. Technology can be leveraged to bring pediatric obesity interventions into real-world practice, with meaningful and sustainable public health impact by addressing barriers to treatment (e.g., lack of providers, logistical barriers). This Direct to Phase II SBIR project will expand upon an existing interventionist training platform to develop and pilot test an innovative, "all-in-one" online pediatric weight management intervention, increasing access to guideline-based obesity care for children and adolescents with obesity and their families. Terms: <0-11 years old; 18 year old; 18 years of age; 21+ years old; Access to Care; Active Follow-up; Address; Adolescent; Adolescent Youth; Adult; Adult Human; Adult-Onset Diabetes Mellitus; Advisory Committees; Affect; Behavior Conditioning Therapy; Behavior Modification; Behavior Therapy; Behavior Treatment; Behavioral; Behavioral Conditioning Therapy; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Care Givers; Caregivers; Caring; Child; Child Care; Child Youth; Childhood; Children (0-21); Clinic; Collaborations; Computer software; Conditioning Therapy; Consultations; Data; Development; Disease; Disorder; Dissemination and Implementation; Dose; E-learning; Elements; Equity; Evidence based intervention; Evidence based treatment; Family; Family Process; Federally Qualified Health Center; Feedback; Focus Groups; Fostering; Funding; Goals; Guidelines; Health Care Providers; Health Care Systems; Health Personnel; Health Services Accessibility; Health system; Healthcare; Healthcare Providers; Healthcare Systems; Healthcare worker; Individual; Instruction; Intervention; Intervention Strategies; Ketosis-Resistant Diabetes Mellitus; Leadership; Learning; Market Research; Marketing; Maturity-Onset Diabetes Mellitus; Medical; Methods; Monitor; NICHD; NIDDM; National Institute of Child Health and Human Development; National Institute of Children's Health and Human Development; Non-Insulin Dependent Diabetes; Non-Insulin-Dependent Diabetes Mellitus; Non-Profit Organizations; Noninsulin Dependent Diabetes; Noninsulin Dependent Diabetes Mellitus; Nonprofit Organizations; Obesity; Onset of illness; Parents; Participant; Phase; Pilot s; Play; Preventative service; Preventive service; Professional Organizations; Provider; Public Health; Puericulture; QOL; Quality of life; Randomized; Recommendation; Research; Research Resources; Resources; Role; SBIR; Secure; Slow-Onset Diabetes Mellitus; Small Business Innovation Research; Small Business Innovation Research Grant; Societies; Software; Stable Diabetes Mellitus; System; T2 DM; T2D; T2DM; Task Forces; Technology; Testing; Time; Training; Translating; Type 2 Diabetes Mellitus; Type 2 diabetes; Type II Diabetes Mellitus; Type II diabetes; U.S. Preventative Services Task Force; U.S. Preventative Task Force; U.S. Preventive Services Task Force; U.S. Preventive Task Force; US Preventative Services Task Force; US Preventative Task Force; US Preventive Health Services Task Force; US Preventive Services Task Force; US Preventive Task Force; USPSTF; United States Preventative Services Task Force; United States Preventative Task Force; United States Preventive Services Task Force; United States Preventive Task Force; Universities; Washington; Weight; Weight maintenance regimen; Youth; Youth 10-21; acceptability and feasibility; access to health services; access to services; access to treatment; accessibility to health services; active followup; adiposity; adult onset diabetes; adulthood; advisory team; age 18 years; aged; applied learning; availability of services; barrier to care; barrier to health care; barrier to healthcare; barrier to treatment; behavior intervention; behavior outcome; behavioral intervention; behavioral outcome; care access; child adiposity; child obesity; childhood adiposity; childhood obesity; co-morbid; co-morbidity; commercialization; comorbidity; comparative; computer-assisted instruction; computer-based education; computer-based instruction; computer-based learning; computer-based training; consultation; corpulence; developmental; digital; digital education; digital health; digital intervention; digital learning; digital platform; digital technology; disease onset; disorder onset; eLearning; effective intervention; effective therapy; effective treatment; effectiveness and implementation trial; effectiveness/implementation hybrid trial; effectiveness/implementation trial; efficacious intervention; eighteen year old; eighteen years of age; electronic learning; energy balance; evidence base; experience; follow up; follow-up; followed up; followup; hands-on learning; health care; health care personnel; health care worker; health provider; health service access; health services availability; health workforce; healthcare personnel; healthy life-style; healthy lifestyle; implementation intervention; implementation process; improved; indexing; innovate; innovation; innovative; interactive engagement; interactive learning; internet-assisted education; internet-based training; intervention effect; interventional strategy; juvenile; juvenile human; ketosis resistant diabetes; kids; maturity onset diabetes; medical personnel; multi-component intervention; multi-faceted intervention; multi-modal intervention; multicomponent intervention; multifaceted intervention; multimedia learning; multimodal intervention; novel; obese children; obesity during childhood; obesity in children; obesity intervention; obesity therapy; obesity treatment; obstacle to care; obstacle to healthcare; on-line education; on-line learning; online education; online learning; parent; pediatric; pediatric obesity; pilot study; pilot test; pilot trial; post intervention; primary care clinic; primary care setting; process evaluation; professional association; professional membership; professional society; programs; psychosocial outcome; psychosocial sequelae; randomisation; randomization; randomly assigned; response; school based health center; school based health clinic; school health center; school health clinic; service availability; simulation; skill acquisition; skill development; social role; support tools; technology platform; technology system; technology-enhanced learning; tool; treatment access; treatment provider; type 2 DM; type II DM; type two diabetes; usability; virtual learning; web-based instruction; web-based training; weight control; weight management; weights; youngster