UMIN-CTR Clinical Trial

Public title

Effectiveness of Web-Based Self-Disclosure Peer-to-Peer Support for Weight Loss: Randomized Controlled Trial

Acronym

Effectiveness of Web-Based Self-Disclosure Peer-to-Peer Support for Weight Loss: Randomized Controlled Trial

Scientific Title

Effectiveness of Web-Based Self-Disclosure Peer-to-Peer Support for Weight Loss: Randomized Controlled Trial

Scientific Title:Acronym

Effectiveness of Web-Based Self-Disclosure Peer-to-Peer Support for Weight Loss: Randomized Controlled Trial

Region

Japan

Condition

Obesity

Classification by specialty

Medicine in general	Endocrinology and Metabolism	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We developed a web-based peer-conscious health support (WPS) system for weight loss. This study aims to compare the effect of weight change between those using the WPS and those using the conventional e-mail health support (EMS).

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Changes in body weight after three months in the client.

Key secondary outcomes

1.Change in the BMI in the clients
2.Change waist circumference in the clients
3.Chenge in the QOL in the clients
4.Change in the food habit of clients

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

We developed a web-based peer-conscious health support (WPS) system by which participants can receive counseling from a registered dietitian and compare their own changes in weight and lifestyle with those of others.

Interventions/Control_2

The conventional e-mail health support (EMS) Which are mainly for one-to-one communication between three months, have been frequently used for weight loss.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

35

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1.Waist circumference >= 85cm in men or >= 90cm in women, or BMI>= 25 in both sex
2.Equal to or more than 35 years old, and equal to or less than 65 years old
3.Availability of web services in home or the workplace
4.Written informed consent

Key exclusion criteria

Patients receiving prescribed medication for diabetes or kidney disease.

Target sample size

180

Name of lead principal investigator

1st name
Middle name
Last name	Takashi Kawamura

Organization

Kyoto university School of Public Health

Division name

Department of Preventive services

Zip code

Address

Yoshida-Honmachi, Sakyo-ku, Kyoto

TEL

075-753-2426

Email

kawax@kuhp.kyoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Mie Imanaka

Organization

Health Service

Division name

Department of Preventive services

Zip code

Address

Yoshida-Honmachi, Sakyo-ku, Kyoto

TEL

090-7485-7611

Homepage URL

Email

m-imanaka@mail.koka.ac.jp

Institute

Department of Preventive Services,
Kyoto university School of Public health

Institute

Department

Personal name

Organization

Department of Preventive Services,
Kyoto university School of Public health

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

10

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Differences in changes of outcomes between the WPS group and EMS group are shown in Table 2. The loss in body weight was significantly greater in the WPS group than in the EMS group (-1.6 kg versus -0.7 kg, adjusted P=0.038).

Results date posted

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

Recruitment status

Completed

Date of protocol fixation

2007

Year

12

Month

25

Day

Date of IRB

Anticipated trial start date

2008

Year

07

Month

01

Day

Last follow-up date

2009

Year

03

Month

31

Day

Date of closure to data entry

2009

Year

06

Month

30

Day

Date trial data considered complete

2010

Year

03

Month

31

Day

Date analysis concluded

2010

Year

06

Month

30

Day

Other related information

The decrease in BMI was also greater in the WPS group than in the EMS group (-0.6 versus -0.3, adjusted P=0.051). However, there were no significantly different changes in waist circumference. Changes in QOL scores, general health perception, vitality, role functioning related to physical and emotional problems, and mental health, were not significantly different between the groups, either.

Registered date

2012

Year

10

Month

18

Day

Last modified on

2015

Year

11

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010719