Clinical trial NCT05587634: Virtual Peer Health Coaching for Adolescents With Disabilities
Official title: Virtual Peer Health Coaching as an Effective Intervention for Increasing Physical Activity in Adolescents With Physical Disability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Spina Bifida
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Deborah Munroe Noonan Memorial Research Fund
First posted: 2022-10-20
Enrollment: 25
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Participation in physical activity (PA) confers clear physical and psychosocial benefits. Yet, many adolescents with physical disabilities such as cerebral palsy and spina bifida do not engage in regular PA, putting them at increased risk for the detrimental impact of sedentary lifestyles such as high rates of obesity/overweight - adverse health trends that continue into adulthood. To address this PA gap, a feasibility pilot randomized controlled trial is proposed evaluating the utility of a peer health coach intervention to promote PA participation and to improve outcomes related to self-autonomy, self-efficacy, and quality of life in adolescents with physical disabilities. Peer health coaches will themselves be young adults with disabilities, trained in concepts of motivational interviewing and self-determination theory, enabling them to meet participants "where they are at" in their understanding of PA and readiness to change PA behaviors. This study will be novel given that: 1) for the first time, an adult peer health coaching model targeting PA will be adapted to the needs of adolescents with disabilities, 2) the study will employ text messaging and other social media platforms that are highly relevant to an adolescent population, and 3) the study will assess PA participation with use of ActiGraph activity trackers, designed to monitor both duration and intensity of PA in individuals with mobility impairment. The results of this study will be used to inform the design of a future, definitive RCT evaluating the efficacy of a peer health coaching intervention to create meaningful change in physical and psychosocial outcomes. By empowering adolescents with disabilities to take control of their own physical and psychosocial health, this work has the potential to impact the well-being and quality of life of participants for many years to come.

Detailed description: Physical activity is an often overlooked, yet incredibly powerful, tool for empowering adolescents with disabilities to take control of their own physical and psychosocial health. At least 60 minutes of daily physical activity (PA) is recommended for children and adolescents ages 6-17, yet the vast majority of young people with disabilities do not meet these goals. As a result, children and adolescents with disabilities are more likely than their non-disabled peers to experience the detrimental impact of sedentary lifestyles such as high rates of obesity/overweight - adverse health trends that continue into adulthood. Additionally, given that children and adolescents with disabilities remain systematically excluded from community and school-based sports and PA opportunities - a mainstay of social development and confidence-building in able-bodied youth - those with disabilities are more likely to experience social isolation and thus threats to well-being and quality of life.

In this context, prior research has focused on the role of peer health coaching (PHC) to enhance health self-management in individuals with disabilities, demonstrating efficacy in reducing rates of secondary conditions and improving self-efficacy and life satisfaction. PHCs simultaneously act as advisor, supporter, and role model, providing the "hook" that stimulates behavior change. Although the PHC model has also been used to promote participation in PA, studies have focused on adults primarily with spinal cord injury. While it is well known that engagement in PA in adolescence is correlated with similar behaviors in adulthood, no prior trials have explored the efficacy of PHCs in stimulating PA behavior in adolescents with childhood-onset disability.

To explore effective solutions that stimulate PA participation to promote equity and quality of life in adolescents with disabilities, this pilot study will target adolescents with cerebral palsy (CP) and spina bifida (SB), the 2 most common types of childhood-onset physical disability, with the following specific aims:

Primary Objective:

To evaluate the feasibility of conducting an efficacy trial of the first virtual PHC intervention aimed to increase PA participation in adolescents with CP and SB. This will include assessing the acceptability of the intervention to our key stakeholders - adolescents with disabilities and their families.

Secondary Objective:

To determine the responsiveness of selected outcome measures to the first virtual PHC intervention in adolescents with CP and SB. Outcomes will include the assessment of a) physical activity, b) psychosocial health, and c) quality of life.

Eligibility criteria: Inclusion Criteria:

* Adolescents ages 12-17 years
* Primary residence in cities and towns within greater Boston
* Presence of CP or SB resulting in mobility limitation
* CP - Gross Motor Function Classification System (GMFCS) level II and III
* SB - myelomeningocele, lipomyelomeningocele, or tethered cord syndromes with motor impairment
* Fluent in conversational English
* Able to utilize a personal cell phone for verbal and text message communications
* Intentions of engaging in PA

Exclusion Criteria:

* Presence of significant cognitive impairment - IQ below 55 as measured by Wechsler Intelligence Score for Children (WISC) or Wechsler Adult Intelligence Scale (WAIS), or those below a 3rd grade reading level
* Use of power mobility as the primary form of mobility on a daily basis

Primary outcomes:
measure: Feasibility measure: Recruitment
timeFrame: Months 1-12 for the overall study
measure: Feasibility measure: Recruitment
timeFrame: Months 1-12 for the overall study
measure: Feasibility: Stratification for age
timeFrame: Months 1-12 for the overall study
measure: Feasibility: Stratification for sex
timeFrame: Months 1-12 for the overall study
measure: Feasibility: Stratification for diagnosis
timeFrame: Months 1-12 for the overall study
measure: Feasibility: Attrition
timeFrame: Months 1-3 for participants; Months 1-15 of overall study
measure: Feasibility: Participant Engagement and Adherence to Intervention with Coach
timeFrame: Months 1-3 for intervention participants; Months 1-15 of overall study
measure: Feasibility: Participant Engagement and Adherence to Intervention: Post Call Questionnaires
timeFrame: Months 1-3 for intervention participants; Months 1-15 of overall study
measure: Feasibility: Peer Health Coach Engagement and Implementation of Intervention: Checklist
timeFrame: Months 1-3 for intervention participants; Months 1-15 of overall study
measure: Feasibility: Peer Health Coach Engagement and Implementation of Intervention: Questionnaires
timeFrame: Months 1-3 for intervention participants; Months 1-15 of overall study
measure: Feasibility: Peer Health Coach Engagement and Implementation of Intervention: Coaching Sessions
timeFrame: Months 1-3 for intervention participants; Months 1-15 of overall study
measure: Acceptability: Intervention Participants Qualitative Satisfaction with Peer Health Coach Intervention
timeFrame: Month 3 (after completion of intervention) for intervention participants
measure: Acceptability: Intervention Participants Quantitative Satisfaction with Peer Health Coach Intervention
timeFrame: Month 3 (after completion of intervention) for intervention participants
measure: Acceptability: Intervention Participants Qualitative Impact of Peer Health Coach Intervention
timeFrame: Month 6 (3 months post-intervention) for intervention participants
measure: Acceptability: Intervention Participants Evaluation of Collaboration of the Peer Health Coach
timeFrame: Month 3 (after completion of intervention) for intervention participants
Secondary outcomes:
measure: Actigraph Electronic Physical Activity Tracker Compliance
timeFrame: Months 1-3 for participants; Months 1-15 of overall study
measure: Arc Self-Determination Scale
timeFrame: At the following time points for participants: 6 weeks, 12 weeks, 6 months
measure: The PedsQL Measurement Model for the Pediatric Quality of Life Inventory
timeFrame: At the following time points for participants: 6 weeks, 12 weeks, 6 months
measure: Physical Activity Self-Efficacy Scale: Adolescent Protocol
timeFrame: At the following time points for participants: 6 weeks, 12 weeks, 6 months
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Cheri Blauwet, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Kleis RR, Hoch MC, Hogg-Graham R, Hoch JM. The Effectiveness of the Transtheoretical Model to Improve Physical Activity in Healthy Adults: A Systematic Review. J Phys Act Health. 2021 Jan 1;18(1):94-108. doi: 10.1123/jpah.2020-0334. Epub 2020 Dec 1.
citation: Young MD, Plotnikoff RC, Collins CE, Callister R, Morgan PJ. Social cognitive theory and physical activity: a systematic review and meta-analysis. Obes Rev. 2014 Dec;15(12):983-95. doi: 10.1111/obr.12225. Epub 2014 Oct 7.