A novel mobile app assistant for weight control
| ISRCTN | ISRCTN16082909 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16082909 |
| Secondary identifying numbers | C012022 |
- Submission date
- 10/11/2022
- Registration date
- 11/11/2022
- Last edited
- 27/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Obesity has become a public health issue worldwide. This pilot study aims to investigate the effect of a mobile app to assist weight management.
Who can participate?
Adults aged 30-60 years old who are overweight
What does the study involve?
Participants are randomly allocated to the control-first group or the intervention-first group. In period 1 (up to day 30), the control-first group continues with their regular life and the intervention-first group undergoes the app intervention; in period 2 (up to day 60), the groups cross over. The app provides a digital program to help users identify unhealthy eating behaviours and make positive behavioural changes. Body composition and psychological/behavioural questionnaires will be collected at the start of the study and at the end of period 1 (day 30), and at the end of period 2 (day 60).
What are the possible benefits and risks of participating?
Participants could improve their own eating behaviours and live healthier lifestyles. There are no potential risks.
Where is the study run from?
Kaohsiung University Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
January 2021 to August 2021
Who is funding the study?
Ministry of Science and Technology (Taiwan)
Who is the main contact?
Dr Jia-In Lee, u9400039@gmail.com
Contact information
Principal Investigator
No.100 , Tzyou 1st Road Kaohsiung 807
Kaohsiung
807
Taiwan
 ORCID ID |
0000-0002-0679-6471 |
|---|---|
| Phone | +886 (0)7 3121101 ext 6822 |
| 1050644@kmuh.org.tw |
Study information
| Study design | Single-center randomized cross over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effect of a novel telehealth device for dietary cognitive behavioral intervention in overweight or obesity care |
| Study acronym | CogniAI |
| Study objectives | This pilot study was aimed to investigate the effect of telehealth assisted intervention on weight reduction, mood status, and eating behavior change under a smartphone application (app) with novel 3D food picture recognition and incorporated with cognitive behavioral training programs. |
| Ethics approval(s) | Approved 13/04/2021, the Institutional Review Board at Kaohsiung Medical University Hospital (No. 100, Tzyou 1st Road Kaohsiung 807, Taiwan; +886 (0)7 3121101 ext 6646; irb-training@kmuh.org.tw), ref: KMUHIRB-E[I]-20210067 |
| Health condition(s) or problem(s) studied | Management of body weight in patients with overweight or obesity |
| Intervention | Adults aged 30-60 years old with overweight will be recruited and randomly assigned (1:1) to the control-first group or the intervention-first group according to their order of entry into the study. In period 1 (up to day 30), the control-first group continues with their regular life and the intervention-first group undergoes the app intervention; in period 2 (up to day 60), the groups cross over. The app provides a digital program to help users identify unhealthy eating behaviors and make positive behavioral changes. Body composition and psychological/behavioral questionnaires will be collected at baseline, end of period 1 (day 30), and end of period 2 (day 60). |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Body composition is measured using InBody 770 (InBodyUSA, Cerritos, CA) at baseline, end of period 1(day 30), and end of period 2 (day 60) |
| Secondary outcome measures | 1. Eating behaviors measured using the Dietary Behavior Questionnaire (DBQ) and Mindful Eating Behavior Scale (MEBS) at baseline, end of period 1 (day 30), and end of period 2 (day 60) 2. Mood measured using the five-item Brief Symptom Rating Scale (BSRS-5) and Chinese version of the Beck Depression Inventory II at baseline, end of period 1 (day 30), and end of period 2 (day 60) 3. Quality of life measured via the WHO Quality-of-Life scale (WHOQOL-BREF)- Taiwan version at baseline, end of period 1 (day 30), and end of period 2 (day 60) 4. Physical activity measured using the Taiwan version of the International Physical Activity Questionnaire Short Form (IPAQ-SF) at baseline, end of period 1 (day 30), and end of period 2 (day 60) 5. Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI) at baseline, end of period 1 (day 30), and end of period 2 (day 60) |
| Overall study start date | 14/01/2021 |
| Completion date | 26/08/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Adults aged between 30 and 60 years 2. Body mass index (BMI) ≥25 kg/m² |
| Key exclusion criteria | Major neuropsychiatric comorbidities, for example, schizophrenia, major depressive disorders, stroke, epilepsy, and Parkinson’s disease |
| Date of first enrolment | 02/06/2021 |
| Date of final enrolment | 07/06/2021 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Kaohsiung
807
Taiwan
Sponsor information
Hospital/treatment centre
No. 100 , Tzyou 1st Road Kaohsiung 807
Kaohsiung City
807
Taiwan
| Phone | +886 (0)7 3121101 |
|---|---|
| 1050644@kmuh.org.tw | |
| Website | http://www.kmuh.org.tw/ |
"ROR" |
https://ror.org/02xmkec90 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Ministry of Science and Technology, R.O.C. (Taiwan), Ministry of Science and Technology of Taiwan, MOST
- Location
- Taiwan
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The main data supporting the findings of this study are available within the paper and its supplementary information files. Extra data are available from the corresponding author upon request: Dr Jia-In Lee (1050644@kmuh.org.tw). The type of data that will be shared: all the raw data. Timing for availability: after being published. Whether consent from participants was required and obtained. Comments on data anonymization: all personal data are de-identification and replaced with study ID. Any ethical or legal restrictions: requested data are only used for research. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/04/2023 | 27/04/2023 | Yes | No |
Editorial Notes
27/04/2023: Publication reference added.
10/11/2022: Trial's existence confirmed by the Institutional Review Board at Kaohsiung Medical University Hospital.
