Physical Activity on Prescription for Children With Obesity

Study Overview
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Brief Summary
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Background: physical inactivity is a main cause of childhood obesity. Physical activity on prescription (PAP) is an evidence-based intervention for adults, but has not been evaluated in children with obesity. Aim: to evaluate the feasibility of a PAP intervention for children with obesity by assessing both clinical patient outcomes and implementation outcomes. Method: a single-arm clinical trial in which children with obesity participate in a 4-month PAP intervention. Measurement points are baseline and 4 months, with long-term follow-ups at 8 and 12 months. Population: children with obesity. Intervention: physical activity on prescription (PAP). Patient outcomes: physical activity level/pattern (including sedentary time), BMI, waist circumference, metabolic risk markers, health-related quality of life, self-efficacy for physical activity, motivation for physical activity. Implementation outcomes: coherence, cognitive participation, collective action, and reflexive monitoring in relation to PAP (the four core constructs of the Normalization Process Theory); appropriateness, acceptability and feasibility of PAP; barriers and facilitators for implementing PAP; recruitment and attrition rates, and intervention fidelity and adherence.

Detailed Description
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Physical inactivity is a main cause of childhood obesity which tracks into adulthood obesity, making it important to address early in life. Physical activity on prescription (PAP) is an evidence-based intervention developed in Sweden that has shown good effect on physical activity levels in adults, but has not been evaluated in children with obesity. This clinical study is nested in a larger research project aiming to assess the prerequisites, determinants, and feasibility of implementing PAP adapted to children with obesity in paediatric health care. Children's and parents' experiences of participating in the PAP intervention will also be explored. In a first, pre-clinical trial, phase, healthcare providers and managers from 26 paediatric clinics in Region Västra Götaland, Sweden, will participate in a web-based survey, and a subset of this sample in a focus group study. Findings from these two data collections will form the basis for further development and adaptation of PAP to the target group and context. In the project's second phase, this adapted PAP intervention will be evaluated in a clinical study in a sample of approximately 60 children with obesity, between 6 and 12 years of age, and one of their parents/legal guardians. Clinical and implementation outcomes will be assessed pre- and post-intervention, and at 8 and 12 months' follow-up. Clinical outcomes are physical activity level/pattern, BMI, waist circumference, metabolic risk markers (blood pressure, fasting plasma glucose, high- and low-density lipoprotein cholesterol, insulin resistance, and triglycerides), quality of life, self-efficacy and motivation for physical activity, and intervention satisfaction. Implementation outcomes are the four core constructs of the Normalization Process Theory; coherence, cognitive participation, collective action, and reflexive monitoring; appropriateness, acceptability and feasibility of the PAP intervention; barriers and facilitators for implementing PAP; recruitment and attrition rates, and intervention fidelity and adherence. The clinical study is nested in a larger research project employing a hybrid implementation-effectiveness design. Design and analysis of the included studies is guided by the Normalization Process Theory.

Official Title
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Implementation of Physical Activity on Prescription for Children With Obesity in Paediatric Health Care (IMPA): a Feasibility Study

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Behavioral: Physical activity on prescription (PAP)


Participation Criteria
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Eligibility Criteria
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Pre-trial phase/healthcare practitioner: Inclusion criteria: - being a healthcare practitioner or manager involved in the treatment of children with obesity at a paediatric healthcare clinic in Region Västra Götaland Clinical trial/patients: Inclusion criteria: aged 6-12 years diagnosed with obesity (age adjusted BMI>ISO-BMI 30) having an insufficient physical activity level according to national recommendations being willing to participate and perform the chosen activity/-ies having a parent who is willing to participate. Exclusion criteria: severe psychiatric comorbidity severe intellectual or physical disability

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity on prescription<br>Physical activity on prescription is a behaviour change intervention comprising 3 components: a person-centred pre-intervention dialogue, a written prescription for individually tailored physical activity, and a structured follow-up. | Behavioral: Physical activity on prescription (PAP)<br>* The intervention in this study will comprise the 3 PAP components. Participants will take part in all components and perform one or several physical activities of their choice in accordance to the written prescription, at the prescribed frequency and duration, for a period of 4 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity level | Change in time spent in moderate to vigorous physical activity, measured with accelerometry | 4, 8, 12 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity pattern | Change in sedentary time, time spent in low, moderate and vigorous physical activity, measured with accelerometry | 4, 8, 12 months after baseline | 
| Change in BMI | Change in age- and sex adjusted BMI (measured as weight and height combined to BMI). This outcome will also be measured as BMI Standard deviation score (SDS) | 4, 8, 12 months after baseline | 
| Change in health-related quality of life | Change in self-reported health-related quality of life, measured with KIDSCREEN-10 | 4, 8, 12 months after baseline | 
| Change in self-efficacy for physical activity | Change in perceived self-efficacy for physical activity, measured with the Self-efficacy for physical activity questionnaire | 4, 8, 12 months after baseline | 
| Change in motivation for physical activity | Change in perceived motivation for physical activity, measured with the Motivation for physical activity questionnaire | 4, 8, 12 months after baseline | 
| Intervention acceptability | Intervention acceptability will be measured with the Client Satisfaction Questionnaire (CSQ-8) | Post-intervention at 4 months | 
| Change in systolic and diastolic blood pressure | Both systolic and diastolic blood pressure will be measured in mmHg | Baseline to 12 months | 
| Change in fasting plasma glucose | Change in fasting plasma glucose will be measured in mmol/litre | Baseline to 12 months | 
| Change in Hemoglobin A1C (HbA1C) | Change in HbA1C will be measured in mmol/litre | Baseline to 12 months | 
| Change in high- and low-density lipoprotein cholesterol | Change in high- and low-density lipoprotein cholesterol will be measured in mmol/litre | Baseline to 12 months | 
| Change in fasting P-insulin | Change in fasting P-insulin will be measured in mIE/litre | Baseline to 12 months | 
| Change in triglycerides | Change in triglycerides will be measured in mmol/litre | Baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, childhood, physical activity