Clinical trial NCT03523806: Children and Teens in Charge of Their Health
Official title: Children and Teens in Charge of Their Health: A Feasibility Study of Solution-focused Coaching to Foster Healthy Lifestyles in Children and Young People With Physical Disabilities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spina Bifida
Cerebral Palsy
Health Behavior
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Laval University
First posted: 2018-05-14
Enrollment: 16
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This three year study explores the feasibility and acceptability of conducting a full randomized controlled trial (RCT) of a promising coaching intervention for improving and sustaining physical activity (PA) and healthy dietary habits in children with physical disabilities (CWPD).

Thirty children (ages 10 - 18) will spend 12 months in the study. All will receive usual care and basic printed information about healthy lifestyles. In addition, 15 will receive a coaching intervention for the first six months. Pre-defined success criteria will assess the feasibility of trial processes.

Acceptability of trial participation and impact of coaching will be explored qualitatively. Health indicators and psychosocial outcomes will be assessed four times, at the start of the trial, immediately post-intervention and at three and six months post-intervention.

Detailed description: The World Health Organization's Global Strategy on Diet, Physical Activity (PA) and Health Promotion highlights that PA and dietary habits are central to disease prevention and lifelong health. Canadian children have increased health risks as their activity levels are drastically lower than recommendations and \~26% are classified as overweight or obese. The situation is even more critical for children with disabilities; 4.2% of Canadian children have disabilities and this number is rising. Due to complex and intersecting factors, children with physical disabilities (CWPD) are more sedentary, have lower PA rates and poorer quality diets than their non-disabled peers. Annual health care costs of obesity related to disability are estimated at $44 billion in the US, supporting the need to start health promotion activities early in life. Despite the serious proximal and distal consequences of this health profile, the investigators lack robust evidence on effective strategies to foster and sustain health habits for CWPD.

A new intervention paradigm that produces sustainable results without undue burden (on families or services) is therefore urgently required to address the health promotion needs of CWPD. The investigators propose that a strengths-based coaching approach may meet all of these requirements. Solution-Focused Coaching in Pediatric Rehabilitation (SFC-Peds) has been recommended as a coaching model for children with disabilities, for its strong theoretical basis and ability to be customized to children and families' resources, environmental settings, child age and developmental stage. Taking a strengths-based approach (such as SFC-Peds) is a departure from usual rehabilitation research and practice, which has largely been problem-focused (i.e. what a child can't do). A strengths-based approach can result in hope, motivation and action.

Given that the investigators will be the first to use SFC-Peds to promote healthy habits with CWPD, a feasibility and acceptability study is essential. Evidence of feasibility is a critical prerequisite for a RCT, especially for complex interventions that have multiple interacting components and/or target multiple behaviours (such as SFC-Peds). Feasibility studies rigorously examine the processes (e.g. recruitment and retention), resources (e.g. personnel, time required to complete measures), management (e.g. coordination of research personnel, quality of data entry) and science (e.g. appropriate methodology and outcomes) of the intended RCT. It is also critical to evaluate the acceptability of interventions for the target population (e.g. satisfaction with duration, intensity, level of interest, perceived impact), as well as those allocated to the control arm (e.g. acceptability of not receiving coaching, perceived burden of assessments). Examining all of these issues before the efficacy trial begins increases the likelihood of success. Feasibility studies such as the one the investigators are proposing help ensure that resources are invested in efficacy trials likely to generate clinically meaningful results and therefore have maximum impact on health care knowledge and outcomes.

Primary objective: To evaluate the feasibility (study design, methods, processes) and acceptability (family/child/clinician satisfaction, perceived usefulness) of conducting a randomized controlled trial (RCT) of a novel, brief, coaching intervention, solution-focused coaching in pediatric rehabilitation (SFC-Peds) for improving and sustaining physical activity (PA) and dietary habits in children with physical disabilities (CWPD).

Secondary objective: To determine the responsiveness of selected outcome measures to SFC-Peds coaching over 12 months.

Principal research question: "Is an efficacy trial to evaluate a 6 month SFC-Peds intervention to improve PA and dietary habits feasible to implement and acceptable to CWPD and families?"

Physical, environmental and psychosocial restrictions mean that children with physical disabilities (CWPD) are adopting worrying physical activity (PA) and dietary habits. Despite this, the investigators currently have limited evidence to inform interventions that may enhance lifelong health in CWPD. The investigators suggest that a paradigm shift is needed, one that moves beyond traditional prescriptive programs to a strengths-based approach where intervention strategies enable new health habits to be integrated seamlessly into children and families' everyday lifestyles for long-term sustainability.

Research such as our proposed study will ensure that this potentially transformative approach is rigorously examined and used in an evidence-based manner. As little is known about effective and acceptable behaviour change interventions for CWPD, this study's findings will make significant contributions to the field: i) Greater understanding of ecologically valid interventions that have the potential to enhance the long term health of CWPD; ii) Insight into how 2 different rehabilitation populations respond to SFC-Peds; and iii) Data on the responsiveness of outcome measures to a SFC-Peds intervention. These insights will enable us to design acceptable, feasible and rigorous interventions that will result in robust data for informing both research and clinical practice.

Eligibility criteria: Child Inclusion Criteria:

* Between the age of 10 - 18 years inclusive
* Diagnosis of SB or CP
* Has physical capability to execute independent body movement with or without device
* Cognitively able and willing to set PA or dietary goals
* Can communicate in English and respond to questions requiring some reflection and insight
* Home internet connection
* Lives within 2 hours driving distance from Toronto up to London, Ontario OR willing to travel to either HB or TVCC for first in-person coaching session if randomized into coaching group

Child exclusion criteria:

* Surgery in past 6 months or upcoming 12 months that may impact PA or dietary intake (e.g. orthopedic surgery or neurosurgery)
* Medical condition severely restricting diet
* Underweight (less than fifth percentile)
* Receiving specialist dietetic services

Parent inclusion criteria:

* Primary caregiver to a study participant
* Can communicate in English and respond to questions requiring some reflection and insight

Primary outcomes:
measure: Change in Canadian Occupational Performance Measure (COPM) scores
timeFrame: At first coaching session (immediately post-study enrollment/randomization) and at Time 2 (immediately post-coaching), 3 (3 months post-coaching), 4 (6 months post-coaching)
Secondary outcomes:
measure: Change Goal Attainment Scaling (GAS) scores
timeFrame: At first coaching session (immediately post-study enrollment/randomization) and at Time 2 (immediately post-coaching), 3 (3 months post-coaching), 4 (6 months post-coaching)
Other outcomes:
measure: Change in Habitual Activity Estimation Scale scores
timeFrame: Time 1 Baseline (upon study enrollment), Time 2 (6 months post-baseline or immediately post-coaching), 3 (9 months post-baseline or 3 months post coaching), 4 (12 months post-baseline or 6 months post-coaching)
measure: Change in Dietary Screener Questionnaire scores
timeFrame: Time 1 Baseline (upon study enrollment), Time 2 (6 months post-baseline or immediately post-coaching), 3 (9 months post-baseline or 3 months post coaching), 4 (12 months post-baseline or 6 months post-coaching)
measure: Change in Arc's Self-Determination Scale scores
timeFrame: Time 1 Baseline (upon study enrollment), Time 2 (6 months post-baseline or immediately post-coaching), 3 (9 months post-baseline or 3 months post coaching), 4 (12 months post-baseline or 6 months post-coaching)
measure: Change in Physical Activity Self-efficacy Scale scores
timeFrame: Time 1 Baseline (upon study enrollment), Time 2 (6 months post-baseline or immediately post-coaching), 3 (9 months post-baseline or 3 months post coaching), 4 (12 months post-baseline or 6 months post-coaching)
measure: Change in Self-Efficacy for Healthy Eating scores
timeFrame: Time 1 Baseline (upon study enrollment), Time 2 (6 months post-baseline or immediately post-coaching), 3 (9 months post-baseline or 3 months post coaching), 4 (12 months post-baseline or 6 months post-coaching)
measure: Change in BMI
timeFrame: Time 1 Baseline (upon study enrollment), Time 2 (6 months post-baseline or immediately post-coaching), 3 (9 months post-baseline or 3 months post coaching), 4 (12 months post-baseline or 6 months post-coaching)
measure: Change in the Family Eating and Activity Habits Questionnaire scores
timeFrame: Time 1 Baseline (upon study enrollment), Time 2 (6 months post-baseline or immediately post-coaching), 3 (9 months post-baseline or 3 months post coaching), 4 (12 months post-baseline or 6 months post-coaching)
Locations:
city: London
country: Canada
facility: Thames Valley Children's Centre
state: Ontario
city: Toronto
country: Canada
facility: Holland Bloorview Kids Rehabilitation Hospital
state: Ontario
Study officials:
affiliation: Holland Bloorview Kids Rehabilitation Hospital
name: Amy McPherson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McPherson AC, Biddiss E, Chen L, Church PT, de Groot JF, Keenan S, King G, Lui T, Maltais DB, Merette C, Moffet H, Moola F, Schwellnus H. Children and Teens in Charge of their Health (CATCH): A protocol for a feasibility randomised controlled trial of solution-focused coaching to foster healthy lifestyles in childhood disability. BMJ Open. 2019 Mar 4;9(3):e025119. doi: 10.1136/bmjopen-2018-025119.