Effects of an internet interactive empowerment-based self-management protocol on physiological indicators in adults with metabolic syndrome
| ISRCTN | ISRCTN95637143 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95637143 |
- Submission date
- 01/07/2021
- Registration date
- 05/07/2021
- Last edited
- 02/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Metabolic syndrome is the medical term for a combination of diabetes, high blood pressure (hypertension) and obesity.
Poor control of metabolic syndrome may lead to serious disease, complications, and even life-threatening health problems. The study aims to explore the effects of the internet interactive empowerment-based self-management protocol on adults with metabolic syndrome.
Who can participate?
Adults aged 18 years or above, with metabolic syndrome.
What does the study involve?
Participants will be randomly allocated to the experimental group or the control group.
The experimental group received the internet interactive empowerment-based self-management protocol for 6 weeks and usual care. The website consisted of a home page; a system manual; health education, basic information, self-awareness, and self-management pages; participants’ personal self-management history records; and a health professional contact page.
The control group received internet self-management health education and usual care for 6 weeks.
What are the possible benefits and risks of participating?
The possible benefits are the internet interactive empowerment-based self-management protocol can improve the physiological outcomes, and there are no obvious risks.
Where is the study run from?
Chi-Mei medical center (Taiwan)
When is the study starting and how long is it expected to run for?
October 2016 to October 2018
Who is funding the study?
Chi-Mei medical center (Taiwan)
Who is the main contact?
Chia-Chi Kuo, kuochiachi@yahoo.com.tw
Contact information
Scientific
No.901
Zhonghua Rd.
Yongkang Dist.
Tainan
71101
Taiwan
 ORCID ID |
0000-0003-2194-9007 |
|---|---|
| Phone | +886-0935437462 |
| kuochiachi@yahoo.com.tw |
Study information
| Study design | Two-group pretest-posttest double-blind pilot randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Internet/virtual |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Effects of an internet interactive empowerment-based self-management protocol on physiological indicators in adults with metabolic syndrome: Pilot study |
| Study objectives | The internet interactive empowerment-based self-management intervention group can significantly reduce body weight, body mass index, and waist circumference in adults with metabolic syndrome more than the control group. |
| Ethics approval(s) | Approved 14/10/2016, Institutional review board of Chi-Mei medical center (No.901, Zhonghua Rd., Yongkang Dist., Tainan City 710, Taiwan; +886(6)2812811#53720; csr2930@mail.chimei.org.tw), ref: 10502-008 |
| Health condition(s) or problem(s) studied | Intervention effects on reduction of body weight, body mass index, and waist circumference in adults with metabolic syndrome. |
| Intervention | This pilot randomized controlled trial had a two-group, pretest-posttest (at 6th week and 3rd month), double-blind (participants and outcome assessors) design randomized block design. Convenience sampling was used to recruit 16 participants with metabolic syndrome from a medical center in southern Taiwan. A randomized block design was used to assign participants to the experimental and comparison groups (n=8/group) with an allocation ratio of 1:1. The experimental group received the internet interactive empowerment-based self-management protocol for 6 weeks and usual care. The website consisted of a home page; a system manual; health education, basic information, self-awareness, and self-management pages; participants’ personal self-management history records; and a health professional contact page. The comparison group received internet self-management health education and usual care for 6 weeks. |
| Intervention type | Behavioural |
| Primary outcome measure | At baseline, week 6, and week 12: 1. Body weight (kg) 2. Waist circumference (cm) 3. Body mass index (kg/m²) |
| Secondary outcome measures | Measured by blood test unless noted at baseline, week 6, and week 12: 1. Fasting glucose 2. Glycated hemoglobin 3. Total cholesterol level 4. Triglyceride level 5. High-density lipoprotein cholesterol levels 6. Blood pressure (mmHG, sphygmomanometer) |
| Overall study start date | 14/10/2016 |
| Completion date | 05/10/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 18 |
| Key inclusion criteria | 1. Metabolic syndrome with three or more of the following conditions: 1.1. Waist circumference ≥90cm for males or ≥80cm for females 1.2. Triglycerides ≥150mg/dl 1.3. High-density lipoprotein cholesterol <40mg/dl for males or <50mg/dl for females 1.4. Blood pressure ≥130/85 mmHg 1.5. Fasting glucose ≥100mg/dl 2. Age ≥20 years 3. No visual or hearing impairment or psychological disorder 4. Conscious state and ability to communicate in Mandarin or Taiwanese 5. Literacy with at least a primary school education 6. Weekly internet browsing at home |
| Key exclusion criteria | 1. Using medication for hyperlipidemia, hypertension, or diabetes 2. Other serious metabolic complications, such as kidney failure with hemodialysis or heart failure |
| Date of first enrolment | 02/03/2018 |
| Date of final enrolment | 13/07/2018 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Zhonghua Rd.
Yongkang Dist.
Tainan City
710
Taiwan
Sponsor information
Hospital/treatment centre
No.901
Zhonghua Rd.
Yongkang Dist.
Tainan
71101
Taiwan
| Phone | +886(6)2812811#52652 |
|---|---|
| cmh4000@mail.chimei.org.tw | |
| Website | https://www.chimei.org.tw/main/cmh_department/top/54000_index.html |
"ROR" |
https://ror.org/02y2htg06 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Location
- Taiwan
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Editorial Notes
02/02/2022: The intention to publish date has been changed from 15/07/2021 to 31/12/2022.
05/07/2021: Trial’s existence confirmed by the Institutional review board of Chi-Mei Medical Center.
