UMIN-CTR Clinical Trial

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

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Basic information

Public title

The Effects of a diet and exercise guidance program for HIV-infected men with dyslipidemia: a parallel-group randomized controlled trial

Acronym

The Effects of a diet and exercise guidance program for HIV-infected men with dyslipidemia: a parallel-group randomized controlled trial

Scientific Title

The Effects of a diet and exercise guidance program for HIV-infected men with dyslipidemia: a parallel-group randomized controlled trial

Scientific Title:Acronym

The Effects of a diet and exercise guidance program for HIV-infected men with dyslipidemia: a parallel-group randomized controlled trial

Region

Japan


Condition

Condition

HIV infection, Lipid disorders

Classification by specialty

Medicine in general Infectious disease Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change from baseline in LDL cholesterol at 6 months after intervention

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

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.

Interventions/Control_2

No nurse intervention for the control group

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male

Key inclusion criteria

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

Key exclusion criteria

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

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Maki
Middle name
Last name Aomori

Organization

Yokohama City University

Division name

Department of Nursing, School of Medicine

Zip code

236-0004

Address

3-9 in Fukuura, Kanazawa-ku, Yokohama City, Kanagawa, 236-0004, Japan

TEL

045-787-2554

Email

maki428@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name Maki
Middle name
Last name Aomori

Organization

Yokohama City University

Division name

Department of Nursing, School of Medicine

Zip code

236-0004

Address

3-9 in Fukuura, Kanazawa-ku, Yokohama City, Kanagawa, 236-0004, Japan

TEL

045-787-2554

Homepage URL


Email

maki428@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University Hospital

Institute

Department

Personal name



Funding Source

Organization

Grants in aid for scientific research

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Officer, Clinical Research Promotion Division, Department of Medicine and Hospital Administration, Yokohama City University Hospital

Address

5F, Techno Core, Yokohama-Kanazawa High-Tech Center, 1-1-1 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan

Tel

045-370-7627

Email

rinri@yokohama-cu.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

横浜市立大学附属病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2021 Year 06 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://onlinelibrary.wiley.com/doi/10.1111/jjns.12535

Number of participants that the trial has enrolled

42

Results

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).

Results date posted

2023 Year 05 Month 17 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2021 Year 05 Month 10 Day

Date of IRB

2021 Year 04 Month 01 Day

Anticipated trial start date

2021 Year 05 Month 14 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry

2023 Year 10 Month 13 Day

Date trial data considered complete

2023 Year 10 Month 13 Day

Date analysis concluded

2023 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2021 Year 05 Month 15 Day

Last modified on

2023 Year 10 Month 13 Day



Link to view the page

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