Physical Activity on Prescription for Children With Obesity

Obesity, Childhood Clinical Trial

— IMPA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04847271
• Other study ID #: 2020-01244
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: December 2023
• Source: Vastra Gotaland Region
• Contact: Susanne Bernhardsson, Assoc. Prof.
• Phone: +46733223950
• Email: susanne.bernhardsson[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• Physical 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.

Locations

Country	Name	City	State
Sweden	Regionhälsan, Region Västra Götaland	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Swedish Council for Working Life and Social Research

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Coherence, cognitive participation, collective action, and reflexive monitoring will be assessed using the Swedish version of Normalization MeAsure Development (S-NoMAD)	Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months
Other	Change in healthcare practitioners' acceptability of the PAP intervention	Acceptability of PAP will be assessed using the Acceptability of Intervention Measure (AIM)	Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months
Other	Change in healthcare practitioners' appropriateness of the PAP intervention	Appropriateness of PAP will be assessed using the Intervention Appropriateness Measure (IAM)	Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months
Other	Change in healthcare practitioners' feasibility of the PAP intervention	Feasibility of PAP will be assessed using the Feasibility of Intervention Measure (FIM)	Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months
Primary	Change in physical activity level	Change in time spent in moderate to vigorous physical activity, measured with accelerometry	4, 8, 12 months after baseline
Secondary	Change in physical activity pattern	Change in sedentary time, time spent in low, moderate and vigorous physical activity, measured with accelerometry	4, 8, 12 months after baseline
Secondary	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)	4, 8, 12 months after baseline
Secondary	Change in health-related quality of life	Change in self-reported health-related quality of life, measured with KIDSCREEN-10	4, 8, 12 months after baseline
Secondary	Change in self-efficacy for physical activity	Change in perceived self-efficacy for physical activity, measured with the Self-efficacy for physical activity questionnaire	4, 8, 12 months after baseline
Secondary	Change in motivation for physical activity	Change in perceived motivation for physical activity, measured with the Motivation for physical activity questionnaire	4, 8, 12 months after baseline
Secondary	Intervention acceptability	Intervention acceptability will be measured with the Client Satisfaction Questionnaire (CSQ-8)	Post-intervention at 4 months
Secondary	Change in systolic and diastolic blood pressure	Both systolic and diastolic blood pressure will be measured in mmHg	Baseline to 12 months
Secondary	Change in fasting plasma glucose	Change in fasting plasma glucose will be measured in mmol/litre	Baseline to 12 months
Secondary	Change in Hemoglobin A1C (HbA1C)	Change in HbA1C will be measured in mmol/litre	Baseline to 12 months
Secondary	Change in high- and low-density lipoprotein cholesterol	Change in high- and low-density lipoprotein cholesterol will be measured in mmol/litre	Baseline to 12 months
Secondary	Change in fasting P-insulin	Change in fasting P-insulin will be measured in mIE/litre	Baseline to 12 months
Secondary	Change in triglycerides	Change in triglycerides will be measured in mmol/litre	Baseline to 12 months