Physical Activity on Prescription for Children With Obesity

NCT04847271 | Active Not Recruiting

• 1 other identifier: 2020-01244
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Childhood

Keywords

obesity, childhood; physical activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change in physical activity pattern

  4, 8, 12 months after baseline

• Change in BMI

  4, 8, 12 months after baseline

• Change in health-related quality of life

  4, 8, 12 months after baseline

• Change in self-efficacy for physical activity

  4, 8, 12 months after baseline

• Change in motivation for physical activity

  4, 8, 12 months after baseline

Other Outcomes (4)

• 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

  Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months

• Change in healthcare practitioners' acceptability of the PAP intervention

  Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months

• Change in healthcare practitioners' appropriateness of the PAP intervention

  Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months

Study Arms (1)

Physical activity on prescription

EXPERIMENTAL

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.

Behavioral: Physical activity on prescription (PAP)

Interventions

Physical activity on prescription (PAP) 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.

Physical activity on prescription

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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.

You may not qualify if:

• severe psychiatric comorbidity
• severe intellectual or physical disability

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Swedish Council for Working Life and Social Research: collaborator

Study Sites (1)

Regionhälsan, Region Västra Götaland

Gothenburg, Sweden

Location

Related Publications (1)

• 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.

  PMID: 35650617 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Susanne Bernhardsson, Assoc. Prof.

  Vastra Gotaland Region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Research and Development Strategist, R&D primary health care

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 19, 2021
• Study Start: February 7, 2022
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: After completion of the study and publication of study results

Locations

SE (1)