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Active, Not Recruiting

NCT Number: NCT04847271

Physical Activity on Prescription for Children With Obesity

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regionhälsan, Region Västra Götaland

Gothenburg, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity on prescription (PAP)

Behavioral

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.

Primary outcomes

  1. Change in physical activity level

    Time frame: 4, 8, 12 months after baseline

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

Secondary outcomes

  1. Change in physical activity pattern

    Time frame: 4, 8, 12 months after baseline

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

  2. Change in BMI

    Time frame: 4, 8, 12 months after baseline

    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)

  3. Change in health-related quality of life

    Time frame: 4, 8, 12 months after baseline

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

  4. Change in self-efficacy for physical activity

    Time frame: 4, 8, 12 months after baseline

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

  5. Change in motivation for physical activity

    Time frame: 4, 8, 12 months after baseline

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

  6. Intervention acceptability

    Time frame: Post-intervention at 4 months

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

  7. Change in systolic and diastolic blood pressure

    Time frame: Baseline to 12 months

    Both systolic and diastolic blood pressure will be measured in mmHg

  8. Change in fasting plasma glucose

    Time frame: Baseline to 12 months

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

  9. Change in Hemoglobin A1C (HbA1C)

    Time frame: Baseline to 12 months

    Change in HbA1C will be measured in mmol/litre

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

    Time frame: Baseline to 12 months

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

  11. Change in fasting P-insulin

    Time frame: Baseline to 12 months

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

  12. Change in triglycerides

    Time frame: Baseline to 12 months

    Change in triglycerides will be measured in mmol/litre

Other outcomes

  1. 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

    Coherence, cognitive participation, collective action, and reflexive monitoring will be assessed using the Swedish version of Normalization MeAsure Development (S-NoMAD)

  2. 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

    Acceptability of PAP will be assessed using the Acceptability of Intervention Measure (AIM)

  3. 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

    Appropriateness of PAP will be assessed using the Intervention Appropriateness Measure (IAM)

  4. 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

    Feasibility of PAP will be assessed using the Feasibility of Intervention Measure (FIM)

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Swedish Council for Working Life and Social Research

Registry information

Official study title

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

Acronym: IMPA

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 19, 2021
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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