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Obesity, ChildhoodIMPANCT04847271

Physical Activity on Prescription for Children With Obesity

A study testing Physical activity on prescription (PAP) in people with Obesity, Childhood, run by Vastra Gotaland Region at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Obesity, Childhood
What is being tested?
Physical activity on prescription (PAP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteSweden
Study dates
7 Feb 2022to 31 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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:
  • 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.

Who cannot join

  • severe psychiatric comorbidity
  • severe intellectual or physical disability

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Regionhälsan, Region Västra Götaland

    Gothenburg

Other trials in Sweden

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Physical activity on prescription (PAP)
Keywords
obesity, childhood, physical activity
Medical subject headings
Pediatric Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activity on prescription (PAP)Behavioural

    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.

Study groups in NCT04847271
Study groupRoleWhat they receive
Physical activity on prescriptionExperimentalPhysical 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.
Receives: Behavioral: Physical activity on prescription (PAP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in physical activity level

    Change in time spent in moderate to vigorous physical activity, measured with accelerometry

    Measured: 4, 8, 12 months after baseline

Secondary outcomes (12)

  1. Change in physical activity pattern

    Change in sedentary time, time spent in low, moderate and vigorous physical activity, measured with accelerometry

    Measured: 4, 8, 12 months after baseline

  2. 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)

    Measured: 4, 8, 12 months after baseline

  3. Change in health-related quality of life

    Change in self-reported health-related quality of life, measured with KIDSCREEN-10

    Measured: 4, 8, 12 months after baseline

  4. Change in self-efficacy for physical activity

    Change in perceived self-efficacy for physical activity, measured with the Self-efficacy for physical activity questionnaire

    Measured: 4, 8, 12 months after baseline

  5. Change in motivation for physical activity

    Change in perceived motivation for physical activity, measured with the Motivation for physical activity questionnaire

    Measured: 4, 8, 12 months after baseline

  6. Intervention acceptability

    Intervention acceptability will be measured with the Client Satisfaction Questionnaire (CSQ-8)

    Measured: Post-intervention at 4 months

  7. Change in systolic and diastolic blood pressure

    Both systolic and diastolic blood pressure will be measured in mmHg

    Measured: Baseline to 12 months

  8. Change in fasting plasma glucose

    Change in fasting plasma glucose will be measured in mmol/litre

    Measured: Baseline to 12 months

  9. Change in Hemoglobin A1C (HbA1C)

    Change in HbA1C will be measured in mmol/litre

    Measured: Baseline to 12 months

  10. Change in high- and low-density lipoprotein cholesterol

    Change in high- and low-density lipoprotein cholesterol will be measured in mmol/litre

    Measured: Baseline to 12 months

  11. Change in fasting P-insulin

    Change in fasting P-insulin will be measured in mIE/litre

    Measured: Baseline to 12 months

  12. Change in triglycerides

    Change in triglycerides will be measured in mmol/litre

    Measured: Baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2021
  2. Study start7 Feb 2022
  3. Primary completion31 May 2025
  4. Study completion31 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04847271
Sponsor's protocol ID
2020-01244
Acronym
IMPA
Status last verified
Jul 2024
First submitted
29 Mar 2021
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD will be shared upon reasonable request

Publications

  • Tornqvist J, Lauruschkus K, Bernhardsson S, Melin K, Karlsson L, Arvidsson D, Fridolfsson J, Greven C, Lundqvist S. Addressing insufficient physical activity in children with obesity in a 4-month physical activity on prescription intervention: a single-group pre-post study. BMC Public Health. 2026 Aug 20;26(1):2407. doi: 10.1186/s12889-026-29071-9.

    PubMed 42625158

  • Bernhardsson S, Boman C, Lundqvist S, Arvidsson D, Borjesson M, Larsson MEH, Lundh H, Melin K, Nilsen P, Lauruschkus K. Implementation of physical activity on prescription for children with obesity in paediatric health care (IMPA): protocol for a feasibility and evaluation study using quantitative and qualitative methods. Pilot Feasibility Stud. 2022 Jun 1;8(1):117. doi: 10.1186/s40814-022-01075-3.

    PubMed 35650617

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity on prescription (PAP) in people with Obesity, Childhood, run by Vastra Gotaland Region at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in physical activity level (time frame: 4, 8, 12 months after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04847271, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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