Clinical trial NCT04847271: Physical Activity on Prescription for Children With Obesity
Official title: Implementation of Physical Activity on Prescription for Children With Obesity in Paediatric Health Care (IMPA): a Feasibility Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Keywords: obesity, childhood
physical activity
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Swedish Council for Working Life and Social Research
First posted: 2021-04-19
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in physical activity level
timeFrame: 4, 8, 12 months after baseline
Secondary outcomes:
measure: Change in physical activity pattern
timeFrame: 4, 8, 12 months after baseline
measure: Change in BMI
timeFrame: 4, 8, 12 months after baseline
measure: Change in health-related quality of life
timeFrame: 4, 8, 12 months after baseline
measure: Change in self-efficacy for physical activity
timeFrame: 4, 8, 12 months after baseline
measure: Change in motivation for physical activity
timeFrame: 4, 8, 12 months after baseline
measure: Intervention acceptability
timeFrame: Post-intervention at 4 months
measure: Change in systolic and diastolic blood pressure
timeFrame: Baseline to 12 months
measure: Change in fasting plasma glucose
timeFrame: Baseline to 12 months
measure: Change in Hemoglobin A1C (HbA1C)
timeFrame: Baseline to 12 months
measure: Change in high- and low-density lipoprotein cholesterol
timeFrame: Baseline to 12 months
measure: Change in fasting P-insulin
timeFrame: Baseline to 12 months
measure: Change in triglycerides
timeFrame: Baseline to 12 months
Other outcomes:
measure: 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
timeFrame: Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months
measure: Change in healthcare practitioners' acceptability of the PAP intervention
timeFrame: Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months
measure: Change in healthcare practitioners' appropriateness of the PAP intervention
timeFrame: Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months
measure: Change in healthcare practitioners' feasibility of the PAP intervention
timeFrame: Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months
Locations:
city: Gothenburg
country: Sweden
facility: Regionhälsan, Region Västra Götaland
Study officials:
affiliation: Vastra Gotaland Region
name: Susanne Bernhardsson, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.