Stay with me: an eHealth application for parents of overweight children
| ISRCTN | ISRCTN14223427 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14223427 |
- Submission date
- 17/10/2023
- Registration date
- 11/12/2023
- Last edited
- 10/09/2024
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Parents play a crucial role in shaping children’s dietary and activity behavior and are essential partners in treatment but are insufficiently involved. To address this concern, this study will evaluate a new eHealth tool for parents in the form of a mobile application. The tool will offer model-driven lifestyle change suggestions for parents to use in conjunction with inpatient or outpatient treatment for their child. The eHealth tool will be based on an existing online psycho-education platform for parents of children with overweight called ‘Taking action’, in which already many parental behavior change techniques according lifestyle (e.g. affecting children’s dietary intake, physical exercises, sleep, family climate) are included, based on the model of Rhee (2008). This content will be combined with the input of parents and professionals on needs and preferences of use, gathered during focus groups and enriched with interactive tools, which are easy to add in an application. The application will consist of: 1) psycho-education, 2) tools to change behavior to deal with weight problems, and 3) motivation-enhancing elements for behavioral change.
Who can participate?
Parents who possess a smartphone and are fluent in either Dutch, French or English and have children who are overweight and between 5 and 14 years old.
What does the study involve?
Parents will use the app for 12 weeks. Variables will be assessed during different time points.
Where is the study run from?
Ghent University (Belgium)
When is the study starting and how long is it expected to run for?
June 2024 to December 2026
Who is funding the study?
The Kom Op Tegen Kanker foundation of Belgium
Who is the main contact?
Maurane Desmet, Maurane.Desmet@Ugent.be
Contact information
Public, Scientific
Henri Dunantlaan 2
Ghent
9000
Belgium
 ORCID ID |
0000-0001-6338-3078 |
|---|---|
| Phone | +32 495221500 |
| Maurane.Desmet@Ugent.be |
Principal Investigator
Henri Dunantlaan 2
Ghent
9000
Belgium
| ORCID ID |
0000-0003-2458-287X |
|---|---|
| Caroline.Braet@Ugent.be |
Study information
| Study design | Interventional multiple baseline single case study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Stay with me: an eHealth application for parents of children with overweight: a protocol for a mixed-method study |
| Study acronym | Stay with me |
| Study objectives | An improvement in parent variables regarding parental skills, parental stress, the family climate, and family activities. We will explore the impact of parent characteristics (gender, ethnicity, marital status and SES). Third, we will evaluate treatment adherence. We expect a dose-response relationship, meaning that higher adherence will be significantly correlated with the outcome improvements. |
| Ethics approval(s) |
Not yet submitted, Ethics committee U(Z) Ghent (C. Heymanslaan 10, Ghent, 9000, Belgium; +32 (0)9 332 33 36; ethisch.comite@uzgent.be) |
| Health condition(s) or problem(s) studied | Treatment of children with overweight - focus on parents |
| Intervention | The tool will offer model-driven lifestyle change suggestions for parents to use in conjunction with inpatient or outpatient treatment for their child. The eHealth tool will be based on an existing online psycho-education platform for parents of children with overweight called ‘Taking action’, in which already many parental behavior change techniques according lifestyle (e.g. affecting children’s dietary intake, physical exercises, sleep, family climate) are included, based on the model of Rhee (2008). This content will be combined with the input of parents and professionals on needs and preferences of use, gathered during focus groups and enriched with interactive tools, which are easy to add in an application. The application will consist of: 1) psycho-education, 2) tools to change behavior to deal with weight problems, and 3) motivation-enhancing elements for behavioral change. The intervention phase lasts 12 weeks. The baseline phase will last 3,5 or 7 weeks (multiple baseline design) |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Parents’ age, length and weight and variables linked to socio-economic status (education, profession, country of birth) measured before the baseline phases. 2. Parental feeding behavior will be assessed by the Child Feeding Questionnaire (CFQ) Dutch version before the baseline phases, weekly during baseline and intervention and after the intervention 3. Positive parental behavior will be assessed using a subscale of the Ghent Parental Behavior Scale – Short version (GPBS-S) before the baseline phases, weekly during baseline and intervention and after the intervention 4. Parenting stress will be assessed with the Short Form of the Dutch version of the Parenting Stress Index: the Nijmeegse Ouderlijke Stress Index (NOSIK) before the baseline phases, weekly during baseline and intervention and after the intervention 5. Emotion-coaching will be assessed using the Emotion-Coaching Dimension of the Short Form of the Emotion Related Parenting Styles (ERPS) questionnaire before the baseline phases, weekly during baseline and intervention and after the intervention 6. The adherence of the treatment will be extracted by the analytics generated by the application during the intervention. The number of days of app usage will be used. |
| Secondary outcome measures | We will also ask parents how they experienced using the app after the intervention via individual interviews. |
| Overall study start date | 17/10/2023 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. The child’s age being between 5 and 14 years old 2. The child’s adjusted BMI >85th percentile 3. Parents possessing smartphone 4. Parents being fluent in either Dutch, French, or English |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/10/2025 |
| Date of final enrolment | 01/02/2026 |
Locations
Countries of recruitment
- Belgium
Study participating centres
Ghent
9000
Belgium
De Haan
8420
Belgium
Antwerpen
2650
Belgium
Jette
1090
Belgium
Sponsor information
University/education
Department of Develomental, Personality and Social Psychology
Henri Dunantlaan 2
Ghent
9000
Belgium
| Phone | +32 495221500 |
|---|---|
| roma.rietjens@komoptegenkanker.be | |
| Website | https://www.ugent.be/en |
"ROR" |
https://ror.org/00cv9y106 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Fight Cancer
- Location
- Belgium
Results and Publications
| Intention to publish date | 01/08/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during the study will be available upon request from Maurane.Desmet@Ugent.be |
Editorial Notes
10/09/2024: The following changes were made to the study record:
1. Ethics approval details added.
2. The recruitment start date was changed from 09/01/2024 to 01/10/2025.
3. The recruitment end date was changed from 11/01/2024 to 01/02/2026.
4. The overall study end date was changed from 31/12/2025 to 31/12/2026.
5. The intention to publish date was changed from 01/03/2026 to 01/08/2026.
03/07/2024: The following changes were made to the study record:
1. The recruitment start date was changed from 01/06/2024 to 09/01/2024.
2. The recruitment end date was changed from 31/07/2024 to 11/01/2024.
3. Total final enrolment added.
07/03/2024: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/03/2024 to 01/06/2024.
2. The recruitment end date was changed from 31/05/2024 to 31/07/2024.
20/10/2023: Trial's existence confirmed by Ghent University.
