Physical Activity on Prescription for Children With Obesity

NCT ID: NCT04847271

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-07
• Study Completion Date: 2025-05-31

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.

Conditions

Obesity, Childhood

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physical activity on prescription

Physical activity on prescription is a behaviour change intervention comprising 3 components: a person-centred pre-intervention dialogue, a written prescription for individually tailored physical activity, and a structured follow-up.

Group Type: EXPERIMENTAL

Physical activity on prescription (PAP)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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:

• 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swedish Council for Working Life and Social Research

OTHER

Sponsor Role: collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Susanne Bernhardsson

Principal investigator, Research and Development Strategist, R&D primary health care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susanne Bernhardsson, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Vastra Gotaland Region

Locations

Regionhälsan, Region Västra Götaland

Gothenburg, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 35650617 (View on PubMed)

Other Identifiers

2020-01244

Identifier Type: -

Identifier Source: org_study_id