Unique ID issued by UMIN | UMIN000044216 |
---|---|
Receipt number | R000049481 |
Scientific Title | The Effects of a diet and exercise guidance program for HIV-infected men with dyslipidemia: a parallel-group randomized controlled trial |
Date of disclosure of the study information | 2021/06/01 |
Last modified on | 2023/10/13 15:55:46 |
The Effects of a diet and exercise guidance program for HIV-infected men with dyslipidemia: a parallel-group randomized controlled trial
The Effects of a diet and exercise guidance program for HIV-infected men with dyslipidemia: a parallel-group randomized controlled trial
The Effects of a diet and exercise guidance program for HIV-infected men with dyslipidemia: a parallel-group randomized controlled trial
The Effects of a diet and exercise guidance program for HIV-infected men with dyslipidemia: a parallel-group randomized controlled trial
Japan |
HIV infection, Lipid disorders
Medicine in general | Infectious disease | Nursing |
Others
NO
To conduct an exploratory study on the effectiveness of a diet and exercise guidance program for male HIV-infected patients with dyslipidemia, using a non-program group as a control.
Efficacy
Change from baseline in LDL cholesterol at 6 months after intervention
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
2
Educational,Counseling,Training
Behavior,custom |
For the intervention group, individual guidance by a nurse will be provided three times in total (once every three months), during which guidance using a smartphone application will be provided every one to two weeks.
No nurse intervention for the control group
20 | years-old | <= |
65 | years-old | > |
Male
1) HIV patients
2) Males between 20 and 65 years of age
3) No change in ART dosage and administration for at least 6 months prior to allocation(One or more of the following applies; LDL 120 mg/dl or more, non-HDL 150 mg/dl or more, TG 150 mg/dl or more, HDL less than 40 mg/dl)according to laboratory data within 6 months before allocation
5) Patients who are able to operate the smartphone application used in this study
1) Receiving dietary and exercise guidance at regular health checkups or specific health checkups
2) Patients taking medication for dyslipidemia
3) Cirrhosis of the liver
4) Renal impairment with GFR less than 30 within the past 3 months
5) Complicated malignant tumor
6) Physician-ordered contraindication or restriction of exercise
7) Dementia according to DSM-5
8) Intellectual disability according to DSM-5
9) Patient is hospitalized
10) Unable to use a smart phone
11) Patients who are deemed inappropriate by the attending physician, nurse, or principal investigator to have physical or psychological problems that make it difficult to implement or continue the program
50
1st name | Maki |
Middle name | |
Last name | Aomori |
Yokohama City University
Department of Nursing, School of Medicine
236-0004
3-9 in Fukuura, Kanazawa-ku, Yokohama City, Kanagawa, 236-0004, Japan
045-787-2554
maki428@yokohama-cu.ac.jp
1st name | Maki |
Middle name | |
Last name | Aomori |
Yokohama City University
Department of Nursing, School of Medicine
236-0004
3-9 in Fukuura, Kanazawa-ku, Yokohama City, Kanagawa, 236-0004, Japan
045-787-2554
maki428@yokohama-cu.ac.jp
Yokohama City University Hospital
Grants in aid for scientific research
Other
Ethics Officer, Clinical Research Promotion Division, Department of Medicine and Hospital Administration, Yokohama City University Hospital
5F, Techno Core, Yokohama-Kanazawa High-Tech Center, 1-1-1 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
045-370-7627
rinri@yokohama-cu.ac.jp
NO
横浜市立大学附属病院(神奈川県)
2021 | Year | 06 | Month | 01 | Day |
Published
https://onlinelibrary.wiley.com/doi/10.1111/jjns.12535
42
The primary endpoint was the change in LDL cholesterol levels from baseline to six months post-intervention. On performing this comparison, we found a significant difference in decreased cholesterol levels between the intervention group and the control group (p=0.042).
2023 | Year | 05 | Month | 17 | Day |
Completed
2021 | Year | 05 | Month | 10 | Day |
2021 | Year | 04 | Month | 01 | Day |
2021 | Year | 05 | Month | 14 | Day |
2023 | Year | 03 | Month | 31 | Day |
2023 | Year | 10 | Month | 13 | Day |
2023 | Year | 10 | Month | 13 | Day |
2023 | Year | 12 | Month | 31 | Day |
2021 | Year | 05 | Month | 15 | Day |
2023 | Year | 10 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049481
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |