Regionhälsan, Region Västra Götaland
Gothenburg, Sweden
NCT Number: NCT04847271
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.
This study is active but is not currently recruiting participants.
6 year–12 year
All sexes
Interventional
Not applicable
Gothenburg, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Pre-trial phase/healthcare practitioner:
Inclusion criteria
Clinical trial/patients:
Inclusion criteria
Exclusion criteria
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.
Time frame: 4, 8, 12 months after baseline
Change in time spent in moderate to vigorous physical activity, measured with accelerometry
Time frame: 4, 8, 12 months after baseline
Change in sedentary time, time spent in low, moderate and vigorous physical activity, measured with accelerometry
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)
Time frame: 4, 8, 12 months after baseline
Change in self-reported health-related quality of life, measured with KIDSCREEN-10
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
Time frame: 4, 8, 12 months after baseline
Change in perceived motivation for physical activity, measured with the Motivation for physical activity questionnaire
Time frame: Post-intervention at 4 months
Intervention acceptability will be measured with the Client Satisfaction Questionnaire (CSQ-8)
Time frame: Baseline to 12 months
Both systolic and diastolic blood pressure will be measured in mmHg
Time frame: Baseline to 12 months
Change in fasting plasma glucose will be measured in mmol/litre
Time frame: Baseline to 12 months
Change in HbA1C will be measured in mmol/litre
Time frame: Baseline to 12 months
Change in high- and low-density lipoprotein cholesterol will be measured in mmol/litre
Time frame: Baseline to 12 months
Change in fasting P-insulin will be measured in mIE/litre
Time frame: Baseline to 12 months
Change in triglycerides will be measured in mmol/litre
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)
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)
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)
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)
Vastra Gotaland Region
Other Gov
Implementation of Physical Activity on Prescription for Children With Obesity in Paediatric Health Care (IMPA): a Feasibility Study
Acronym: IMPA
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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