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Peer Health Coaching Intervention for Spina Bifida

N/A
Waitlist Available
Led By Cheri Blauwet, MD
Research Sponsored by Spaulding Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 1-3 for participants; months 1-15 of overall study
Awards & highlights

Study 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.

Eligible Conditions
  • Spina Bifida
  • Cerebral Palsy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 1-3 for participants; months 1-15 of overall study
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 1-3 for participants; months 1-15 of overall study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability: Intervention Participants Evaluation of Collaboration of the Peer Health Coach
Acceptability: Intervention Participants Qualitative Impact of Peer Health Coach Intervention
Acceptability: Intervention Participants Qualitative Satisfaction with Peer Health Coach Intervention
+11 more
Secondary outcome measures
Actigraph Electronic Physical Activity Tracker Compliance
Arc Self-Determination Scale
Physical Activity Self-Efficacy Scale: Adolescent Protocol
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Peer Health Coaching InterventionExperimental Treatment1 Intervention
Intervention Arm - these participants receive individualized peer health coaching (intervention group only) and an adaptive physical activity guide of local resources (both groups)
Group II: ControlActive Control1 Intervention
Control arm - these participants receive only an adaptive physical activity local guide including information on local adaptive sports opportunities however no individualized peer health coaching

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor
134 Previous Clinical Trials
10,990 Total Patients Enrolled
Deborah Munroe Noonan Memorial Research FundOTHER
4 Previous Clinical Trials
313 Total Patients Enrolled
Cheri Blauwet, MDPrincipal InvestigatorSpaulding Rehabilitation Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities left for individuals to participate in the trial?

"The most recent records hosted on clinicaltrials.gov show that this specific medical trial is no longer accepting participants, as it was last updated on October 21st 2022. However, there are still 170 other trials actively recruiting patients at the present moment."

Answered by AI

Who fulfills the eligibility criteria for enrolment in this research?

"The requirements to become a volunteer in this clinical trial necessitates that individuals have cerebral palsy and fall within the age range of 12-17. So far, 25 participants have been accepted into the study."

Answered by AI

What therapeutic outcomes is this experiment looking to realize?

"The primary aim of this clinical trial, which will be observed over a 12 month timeframe, is to analyse the impact of peer health coaching on patient acceptability. The secondary objectives include assessing quality-of-life (5-18 years old) via the PedsQL Measurement Model, physical activity self efficacy with the Adolescent Protocol Scale and determining levels of self determination using Arc Self Determination Scale. Scores from these tests range between 0 and 100 for Quality Of Life; 8 and 40 for Physical Activity Self Efficacy; percentile values for Arc Self Determinations scale respectively - higher scores indicating better results in each case."

Answered by AI

Does this research project consider individuals aged 25 or older as participants?

"This research stipulates that the ideal candidate for this trial is between 12 and 17 years of age. Additionally, there are 146 trials targeting people under 18 and 33 studies focusing on individuals above 65."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I, the submitter, am the parent of a 12 year old with Spina Bifida/lower body paralysis and am contacting you to seek opportunities and options to help my son increase activity, confidence, motivation and focus on future health for my son. Peer to peer interaction sounds positive and there isn’t a great deal of opportunity where we are.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

~5 spots leftby Apr 2025