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Mixed Methods Feasibility Study of an App for Childhood Obesity Prevention and Management

Primary Purpose

Child Obesity

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
NoObesity app
Sponsored by
University of Plymouth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Child Obesity focused on measuring child obesity, digital health, mobile applications, behavior change

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • adult users (over 18 years)
  • fluent in English
  • willing to use the app
  • parents or legal guardians of a child or children OR health care professionals linked to the parent or guardian
  • owner of a smartphone to access the app, with 4G data access

Exclusion Criteria:

  • individuals who are known to the researchers or staff at Health Education England
  • deaf or hearing impairment
  • prior use of the app before study commencement
  • refusal to give informed consent
  • children, vulnerable young people, or vulnerable adults.

Sites / Locations

  • University of Plymouth

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Using the NoObesity app

Arm Description

A mobile digital app ("NoObesity") that enables families to set goals, track progress, play games, and access additional information and healthcare professionals to access training and monitor patients' progress.

Outcomes

Primary Outcome Measures

User experiences and acceptability of the NoObesity app
Measured qualitatively through semi-structured interviews to examine what participants liked, disliked, and what they thought could be improved

Secondary Outcome Measures

Usability of the NoObesity app
Measured using the System Usability Scale (minimum of 0, maximum of 100, higher scores indicate better usability)
Qualitative user perspectives of usability
Qualitative feedback from semi-structured interviews
Perceived impact of app on motivation
Qualitative feedback from semi-structured interviews
Perceived impact of specific app features on motivation
Measured quantitatively on self-report final survey
Perceived impact of app on health behaviours
Qualitative feedback from semi-structured interviews
Self-reported impact of the app on health behaviours
Measured quantitatively on self-report final survey
Perceived impact of app on self-efficacy
Measured quantitatively by assessing users' confidence in their ability to achieve goals in the app and in the final survey
Engagement with the app
Measured using app use data (first and last logins) and self-reported engagement with the app
Factors relating to adoption, implementation, and sustainability
Measured qualitatively in semi-structured interviews with participants and representatives from Health Education England

Full Information

First Posted
February 8, 2022
Last Updated
February 18, 2022
Sponsor
University of Plymouth
Collaborators
Health Education England
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1. Study Identification

Unique Protocol Identification Number
NCT05261555
Brief Title
Mixed Methods Feasibility Study of an App for Childhood Obesity Prevention and Management
Official Title
Acceptability and Usability of a Mobile Health App for Family Obesity Prevention and Management: A Mixed-methods Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 27, 2020 (Actual)
Primary Completion Date
April 28, 2021 (Actual)
Study Completion Date
August 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Plymouth
Collaborators
Health Education England

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
This evaluation evaluated Health Education England's NoObesity digital health app's usability and acceptability to undertake activities improving families' diet, physical activity and weight. The purpose of the study is to evaluate the app's influence on self-efficacy and goal setting and to determine what can be learned to improve its design for future studies, should there be evidence of adoption and sustainability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Obesity
Keywords
child obesity, digital health, mobile applications, behavior change

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Using the NoObesity app
Arm Type
Experimental
Arm Description
A mobile digital app ("NoObesity") that enables families to set goals, track progress, play games, and access additional information and healthcare professionals to access training and monitor patients' progress.
Intervention Type
Device
Intervention Name(s)
NoObesity app
Intervention Description
The NoObesity system consists of two linked apps - the NoObesity Family app and the NoObesity Professional app.
Primary Outcome Measure Information:
Title
User experiences and acceptability of the NoObesity app
Description
Measured qualitatively through semi-structured interviews to examine what participants liked, disliked, and what they thought could be improved
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Usability of the NoObesity app
Description
Measured using the System Usability Scale (minimum of 0, maximum of 100, higher scores indicate better usability)
Time Frame
6 months
Title
Qualitative user perspectives of usability
Description
Qualitative feedback from semi-structured interviews
Time Frame
6 months
Title
Perceived impact of app on motivation
Description
Qualitative feedback from semi-structured interviews
Time Frame
6 months
Title
Perceived impact of specific app features on motivation
Description
Measured quantitatively on self-report final survey
Time Frame
6 months
Title
Perceived impact of app on health behaviours
Description
Qualitative feedback from semi-structured interviews
Time Frame
6 months
Title
Self-reported impact of the app on health behaviours
Description
Measured quantitatively on self-report final survey
Time Frame
6 months
Title
Perceived impact of app on self-efficacy
Description
Measured quantitatively by assessing users' confidence in their ability to achieve goals in the app and in the final survey
Time Frame
6 months
Title
Engagement with the app
Description
Measured using app use data (first and last logins) and self-reported engagement with the app
Time Frame
6 months
Title
Factors relating to adoption, implementation, and sustainability
Description
Measured qualitatively in semi-structured interviews with participants and representatives from Health Education England
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: adult users (over 18 years) fluent in English willing to use the app parents or legal guardians of a child or children OR health care professionals linked to the parent or guardian owner of a smartphone to access the app, with 4G data access Exclusion Criteria: individuals who are known to the researchers or staff at Health Education England deaf or hearing impairment prior use of the app before study commencement refusal to give informed consent children, vulnerable young people, or vulnerable adults.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Meinert, PhD
Organizational Affiliation
University of Plymouth
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Plymouth
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL4 6DN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32706703
Citation
Meinert E, Rahman E, Potter A, Lawrence W, Van Velthoven M. Acceptability and Usability of the Mobile Digital Health App NoObesity for Families and Health Care Professionals: Protocol for a Feasibility Study. JMIR Res Protoc. 2020 Jul 22;9(7):e18068. doi: 10.2196/18068.
Results Reference
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Mixed Methods Feasibility Study of an App for Childhood Obesity Prevention and Management

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