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Physical Activity on Prescription for Children With Obesity (IMPA)

Primary Purpose

Obesity, Childhood

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Physical activity on prescription (PAP)
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Childhood focused on measuring obesity, childhood, physical activity

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regionhälsan, Region Västra GötalandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical activity on prescription

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in physical activity level
Change in time spent in moderate to vigorous physical activity, measured with accelerometry

Secondary Outcome Measures

Change in physical activity pattern
Change in sedentary time, time spent in low, moderate and vigorous physical activity, measured with accelerometry
Change in BMI
Change in age- and sex adjusted BMI (measured as weight and height combined to BMI). This outcome will also be measured as BMI Standard deviation score (SDS)
Change in health-related quality of life
Change in self-reported health-related quality of life, measured with KIDSCREEN-10
Change in self-efficacy for physical activity
Change in perceived self-efficacy for physical activity, measured with the Self-efficacy for physical activity questionnaire
Change in motivation for physical activity
Change in perceived motivation for physical activity, measured with the Motivation for physical activity questionnaire
Intervention acceptability
Intervention acceptability will be measured with the Client Satisfaction Questionnaire (CSQ-8)
Change in systolic and diastolic blood pressure
Both systolic and diastolic blood pressure will be measured in mmHg
Change in fasting plasma glucose
Change in fasting plasma glucose will be measured in mmol/litre
Change in Hemoglobin A1C (HbA1C)
Change in HbA1C will be measured in mmol/litre
Change in high- and low-density lipoprotein cholesterol
Change in high- and low-density lipoprotein cholesterol will be measured in mmol/litre
Change in fasting P-insulin
Change in fasting P-insulin will be measured in mIE/litre
Change in triglycerides
Change in triglycerides will be measured in mmol/litre

Full Information

First Posted
March 29, 2021
Last Updated
February 12, 2022
Sponsor
Vastra Gotaland Region
Collaborators
Swedish Council for Working Life and Social Research
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1. Study Identification

Unique Protocol Identification Number
NCT04847271
Brief Title
Physical Activity on Prescription for Children With Obesity
Acronym
IMPA
Official Title
Implementation of Physical Activity on Prescription for Children With Obesity in Paediatric Health Care (IMPA): a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vastra Gotaland Region
Collaborators
Swedish Council for Working Life and Social Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
Keywords
obesity, childhood, physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical activity on prescription
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity on prescription (PAP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in physical activity level
Description
Change in time spent in moderate to vigorous physical activity, measured with accelerometry
Time Frame
4, 8, 12 months after baseline
Secondary Outcome Measure Information:
Title
Change in physical activity pattern
Description
Change in sedentary time, time spent in low, moderate and vigorous physical activity, measured with accelerometry
Time Frame
4, 8, 12 months after baseline
Title
Change in BMI
Description
Change in age- and sex adjusted BMI (measured as weight and height combined to BMI). This outcome will also be measured as BMI Standard deviation score (SDS)
Time Frame
4, 8, 12 months after baseline
Title
Change in health-related quality of life
Description
Change in self-reported health-related quality of life, measured with KIDSCREEN-10
Time Frame
4, 8, 12 months after baseline
Title
Change in self-efficacy for physical activity
Description
Change in perceived self-efficacy for physical activity, measured with the Self-efficacy for physical activity questionnaire
Time Frame
4, 8, 12 months after baseline
Title
Change in motivation for physical activity
Description
Change in perceived motivation for physical activity, measured with the Motivation for physical activity questionnaire
Time Frame
4, 8, 12 months after baseline
Title
Intervention acceptability
Description
Intervention acceptability will be measured with the Client Satisfaction Questionnaire (CSQ-8)
Time Frame
Post-intervention at 4 months
Title
Change in systolic and diastolic blood pressure
Description
Both systolic and diastolic blood pressure will be measured in mmHg
Time Frame
Baseline to 12 months
Title
Change in fasting plasma glucose
Description
Change in fasting plasma glucose will be measured in mmol/litre
Time Frame
Baseline to 12 months
Title
Change in Hemoglobin A1C (HbA1C)
Description
Change in HbA1C will be measured in mmol/litre
Time Frame
Baseline to 12 months
Title
Change in high- and low-density lipoprotein cholesterol
Description
Change in high- and low-density lipoprotein cholesterol will be measured in mmol/litre
Time Frame
Baseline to 12 months
Title
Change in fasting P-insulin
Description
Change in fasting P-insulin will be measured in mIE/litre
Time Frame
Baseline to 12 months
Title
Change in triglycerides
Description
Change in triglycerides will be measured in mmol/litre
Time Frame
Baseline to 12 months
Other Pre-specified Outcome Measures:
Title
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
Description
Coherence, cognitive participation, collective action, and reflexive monitoring will be assessed using the Swedish version of Normalization MeAsure Development (S-NoMAD)
Time Frame
Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months
Title
Change in healthcare practitioners' acceptability of the PAP intervention
Description
Acceptability of PAP will be assessed using the Acceptability of Intervention Measure (AIM)
Time Frame
Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months
Title
Change in healthcare practitioners' appropriateness of the PAP intervention
Description
Appropriateness of PAP will be assessed using the Intervention Appropriateness Measure (IAM)
Time Frame
Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months
Title
Change in healthcare practitioners' feasibility of the PAP intervention
Description
Feasibility of PAP will be assessed using the Feasibility of Intervention Measure (FIM)
Time Frame
Pre-implementation to post-intervention at 4 months, and long-term follow-up at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susanne Bernhardsson, Assoc. Prof.
Phone
+46733223950
Email
susanne.bernhardsson@vgregion.se
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Boman, PhD student
Email
charlotte.boman@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Bernhardsson, Assoc. Prof.
Organizational Affiliation
Vastra Gotaland Region
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regionhälsan, Region Västra Götaland
City
Gothenburg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Boman
Email
charlotte.boman@vgregion.se
First Name & Middle Initial & Last Name & Degree
Susanne Bernhardsson
Email
susanne.bernhardsson@vgregion.se

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be shared upon reasonable request
IPD Sharing Time Frame
After completion of the study and publication of study results
Citations:
PubMed Identifier
35650617
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.
Results Reference
derived

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Physical Activity on Prescription for Children With Obesity

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