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Physical Activity on Prescription for Children With Obesity

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04847271
Acronym
IMPA
Enrollment
42
Registered
2021-04-19
Start date
2022-02-07
Completion date
2025-05-31
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood

Keywords

obesity, childhood, physical activity

Brief summary

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

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.

Interventions

BEHAVIORALPhysical activity on prescription (PAP)

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.

Sponsors

Vastra Gotaland Region
Lead SponsorOTHER_GOV
Swedish Council for Working Life and Social Research
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in physical activity level4, 8, 12 months after baselineChange in time spent in moderate to vigorous physical activity, measured with accelerometry

Secondary

MeasureTime frameDescription
Change in motivation for physical activity4, 8, 12 months after baselineChange in perceived motivation for physical activity, measured with the Motivation for physical activity questionnaire
Intervention acceptabilityPost-intervention at 4 monthsIntervention acceptability will be measured with the Client Satisfaction Questionnaire (CSQ-8)
Change in systolic and diastolic blood pressureBaseline to 12 monthsBoth systolic and diastolic blood pressure will be measured in mmHg
Change in fasting plasma glucoseBaseline to 12 monthsChange in fasting plasma glucose will be measured in mmol/litre
Change in Hemoglobin A1C (HbA1C)Baseline to 12 monthsChange in HbA1C will be measured in mmol/litre
Change in high- and low-density lipoprotein cholesterolBaseline to 12 monthsChange in high- and low-density lipoprotein cholesterol will be measured in mmol/litre
Change in fasting P-insulinBaseline to 12 monthsChange in fasting P-insulin will be measured in mIE/litre
Change in triglyceridesBaseline to 12 monthsChange in triglycerides will be measured in mmol/litre
Change in physical activity pattern4, 8, 12 months after baselineChange in sedentary time, time spent in low, moderate and vigorous physical activity, measured with accelerometry
Change in BMI4, 8, 12 months after baselineChange 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)
Change in self-efficacy for physical activity4, 8, 12 months after baselineChange in perceived self-efficacy for physical activity, measured with the Self-efficacy for physical activity questionnaire
Change in health-related quality of life4, 8, 12 months after baselineChange in self-reported health-related quality of life, measured with KIDSCREEN-10

Countries

Sweden

Contacts

PRINCIPAL_INVESTIGATORSusanne Bernhardsson, Assoc. Prof.

Vastra Gotaland Region

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026