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Physical Activity on Prescription for Children With Obesity

NCT04847271 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-07-10

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Swedish Council for Working Life and Social Research

    collaborator OTHER

  • Vastra Gotaland Region

    lead OTHER_GOV

Principal Investigators

  • Susanne Bernhardsson, Assoc. Prof. · Vastra Gotaland Region

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-07
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04847271 on ClinicalTrials.gov