- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04847271
Physical Activity on Prescription for Children With Obesity (IMPA)
Implementation of Physical Activity on Prescription for Children With Obesity in Paediatric Health Care (IMPA): a Feasibility Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Susanne Bernhardsson, Assoc. Prof.
- Phone Number: +46733223950
- Email: susanne.bernhardsson@vgregion.se
Study Locations
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-
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Gothenburg, Sweden
- Recruiting
- Regionhälsan, Region Västra Götaland
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Contact:
- Susanne Bernhardsson
- Phone Number: +46733223950
- Email: susanne.bernhardsson@gu.se
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physical activity on prescription
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in physical activity level
Time Frame: 4, 8, 12 months after baseline
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Change in time spent in moderate to vigorous physical activity, measured with accelerometry
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4, 8, 12 months after baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in physical activity pattern
Time Frame: 4, 8, 12 months after baseline
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Change in sedentary time, time spent in low, moderate and vigorous physical activity, measured with accelerometry
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4, 8, 12 months after baseline
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Change in BMI
Time Frame: 4, 8, 12 months after baseline
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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)
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4, 8, 12 months after baseline
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Change in health-related quality of life
Time Frame: 4, 8, 12 months after baseline
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Change in self-reported health-related quality of life, measured with KIDSCREEN-10
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4, 8, 12 months after baseline
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Change in self-efficacy for physical activity
Time Frame: 4, 8, 12 months after baseline
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Change in perceived self-efficacy for physical activity, measured with the Self-efficacy for physical activity questionnaire
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4, 8, 12 months after baseline
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Change in motivation for physical activity
Time Frame: 4, 8, 12 months after baseline
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Change in perceived motivation for physical activity, measured with the Motivation for physical activity questionnaire
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4, 8, 12 months after baseline
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Intervention acceptability
Time Frame: Post-intervention at 4 months
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Intervention acceptability will be measured with the Client Satisfaction Questionnaire (CSQ-8)
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Post-intervention at 4 months
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Change in systolic and diastolic blood pressure
Time Frame: Baseline to 12 months
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Both systolic and diastolic blood pressure will be measured in mmHg
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Baseline to 12 months
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Change in fasting plasma glucose
Time Frame: Baseline to 12 months
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Change in fasting plasma glucose will be measured in mmol/litre
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Baseline to 12 months
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Change in Hemoglobin A1C (HbA1C)
Time Frame: Baseline to 12 months
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Change in HbA1C will be measured in mmol/litre
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Baseline to 12 months
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Change in high- and low-density lipoprotein cholesterol
Time Frame: Baseline to 12 months
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Change in high- and low-density lipoprotein cholesterol will be measured in mmol/litre
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Baseline to 12 months
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Change in fasting P-insulin
Time Frame: Baseline to 12 months
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Change in fasting P-insulin will be measured in mIE/litre
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Baseline to 12 months
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Change in triglycerides
Time Frame: Baseline to 12 months
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Change in triglycerides will be measured in mmol/litre
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Baseline to 12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in healthcare practitioners' attitudes towards PAP in relation to the four core constructs of the NPT: coherence, cognitive participation, collective action, and reflexive monitoring
Time Frame: Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months
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Coherence, cognitive participation, collective action, and reflexive monitoring will be assessed using the Swedish version of Normalization MeAsure Development (S-NoMAD)
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Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months
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Change in healthcare practitioners' acceptability of the PAP intervention
Time Frame: Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months
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Acceptability of PAP will be assessed using the Acceptability of Intervention Measure (AIM)
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Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months
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Change in healthcare practitioners' appropriateness of the PAP intervention
Time Frame: Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months
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Appropriateness of PAP will be assessed using the Intervention Appropriateness Measure (IAM)
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Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months
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Change in healthcare practitioners' feasibility of the PAP intervention
Time Frame: Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months
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Feasibility of PAP will be assessed using the Feasibility of Intervention Measure (FIM)
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Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Susanne Bernhardsson, Assoc. Prof., Vastra Gotaland Region
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-01244
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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