Stay with me: an eHealth application for parents of overweight children
| ISRCTN | ISRCTN14223427 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14223427 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Ghent University |
| Funder | Kom op tegen Kanker |
- Submission date
- 17/10/2023
- Registration date
- 11/12/2023
- Last edited
- 09/02/2026
- 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 app delivers a theory-based lifestyle change recommendations tailored to the parental role in promoting healthy behaviors. Its development was guided by the conceptual framework of Rhee (2008), which emphasizes both direct and indirect parental influences on child weight-related behaviors, as well as by the principles of Goal Setting Theory (Locke & Latham, 1990), which stress the importance of setting specific, achievable, and personally relevant goals in facilitating behavior change. The content and functionality of the app were informed by evidence-based guidelines on healthy lifestyle and parenting. From a co-creation perspective, it was developed with the input from parents and professionals. During an initial exploratory phase, focus groups were conducted to assess user needs and feasibility in order to create and later adapt a first version of the app. The current app consists of several elements. First, we included 6 psycho-education modules, each reflecting a different aspect of a healthy lifestyle: eating behavior, physical activity, self-esteem and body-image, emotion regulation, sleep, and parental stress management. Second, we implemented a goal setting tool for parents to plan SMART changes amongst the health domains that can be tracked and of which parents receive notifications. Third, we added daily tips for keeping the parents engaged. Finally, we also added a “dropbox” in which parents can gather questions for their next session with the caregiver.
Who can participate?
Parents who possess a smartphone and are fluent in Dutch and have a child between 5 and 14 years old with overweight.
What does the study involve?
The study involves a baseline phase of varying baseline durations (1, 1.5 or 2 weeks) for which participants are randomly assigned to. As this study investigates the added value of m-health together with standard care, the baseline phase is a period in which participants receive treatment as usual. Next, in the intervention phase, parents will use the app as a form of blended care for 2 weeks. After this period of 2 weeks, parents are free to choose whether they want to continue using the app. Primary outcomes (intention, attitude, perceived behavioral control and knowledge) will be assessed daily during the baseline and intervention phase. Secondary outcomes (parenting stress, positive parental behaviour, perceived support and healthy parental behavior) will be assessed at four timepoints: at the start of baseline, after baseline, post intervention, and after 6 weeks follow-up.
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 (0)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
| Primary study design | Interventional |
|---|---|
| Study design | Interventional multiple baseline single case study |
| Secondary study design | Non randomised study |
| 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) |
Approved 17/12/2025, Commissie voor Medische Ethiek of University Hospital Ghent (UZ Gent) (Ingang 75, route 7522, C. Heymanslaan 10, Gent, 9000, Belgium; +329 (0)332 33 36; ethisch.comite@uzgent.be), ref: - |
| 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(s) |
1. Parents’ age, length and weight and variables linked to socio-economic status (education, profession, country of birth) measured before the baseline phases. |
| Key secondary outcome measure(s) |
We will also ask parents how they experienced using the app after the intervention via individual interviews. |
| Completion date | 30/12/2026 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 14 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 40 |
| Key inclusion criteria | Current inclusion criteria as of 09/02/2026: 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 Dutch Previous 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 | 02/03/2026 |
| Date of final enrolment | 01/07/2026 |
Locations
Countries of recruitment
- Belgium
Study participating centres
Ghent
9000
Belgium
De Haan
8420
Belgium
Antwerpen
2650
Belgium
Jette
1090
Belgium
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository |
| IPD sharing plan | The datasets generated during the study will be available upon request from Maurane.Desmet@Ugent.be |
Editorial Notes
09/02/2026: The following changes were made to the study record:
1. Ethics approval details added.
2. The date of first enrolment was changed from 01/10/2025 to 02/03/2026.
3. The date of final enrolment was changed from 01/02/2026 to 01/07/2026.
4. The completion date was changed from 31/12/2026 to 30/12/2026.
5. The inclusion criteria and plain English summary were updated.
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.
