Implementation of Physical Activity on Prescription for Children With Obesity in Paediatric Health Care (IMPA): a Feasibility Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Obesity, Childhood
- Sponsor
- Vastra Gotaland Region
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in physical activity level
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Susanne Bernhardsson
Principal investigator, Research and Development Strategist, R&D primary health care
Vastra Gotaland Region
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
- Change in physical activity pattern(4, 8, 12 months after baseline)
- Intervention acceptability(Post-intervention at 4 months)
- Change in systolic and diastolic blood pressure(Baseline to 12 months)
- Change in fasting plasma glucose(Baseline to 12 months)
- Change in triglycerides(Baseline to 12 months)
- Change in high- and low-density lipoprotein cholesterol(Baseline to 12 months)
- Change in BMI(4, 8, 12 months after baseline)
- Change in self-efficacy for physical activity(4, 8, 12 months after baseline)
- Change in Hemoglobin A1C (HbA1C)(Baseline to 12 months)
- Change in motivation for physical activity(4, 8, 12 months after baseline)
- Change in health-related quality of life(4, 8, 12 months after baseline)
- Change in fasting P-insulin(Baseline to 12 months)