UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030444
Receipt number R000034741
Scientific Title Effects of a mindfulness-based intervention versus cognitive behavioral therapy on weight loss and weight maintenance for women with overweight or obesity: a randomized controlled trial.
Date of disclosure of the study information 2017/12/19
Last modified on 2024/02/29 21:51:36

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Basic information

Public title

Effects of a mindfulness-based intervention versus cognitive behavioral therapy on weight loss and weight maintenance for women with overweight or obesity: a randomized controlled trial.

Acronym

Effects of mindfulness compared with cognitive behavioral therapy for obesity: a randomized controlled trial.

Scientific Title

Effects of a mindfulness-based intervention versus cognitive behavioral therapy on weight loss and weight maintenance for women with overweight or obesity: a randomized controlled trial.

Scientific Title:Acronym

Effects of mindfulness compared with cognitive behavioral therapy for obesity: a randomized controlled trial.

Region

Japan


Condition

Condition

Obesity

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of mindfulness compared with cognitive behavioral therapy on weight loss and long-term weight maintenance.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

To examine superiority effect of mindfulness
over cognitive behavioral therapy in 2-years weight maintenance after weight loss 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

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

34-week weight loss intervention including mindfulness-based stress management

Interventions/Control_2

34-week weight loss intervention including cognitive behavioral therapy-based stress management

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

25 years-old <=

Age-upper limit

65 years-old >

Gender

Female

Key inclusion criteria

The study population consists of female participants with obesity and overweight (27<=BMI<40) who are recruited using website and publications, who can complete questionnaires concerning the study and give informed written consent.

Key exclusion criteria

We exclude those subjects who have loosed more than 5kg within recent half year, pregnant or breast-feeding women, have schedule of pregnancy within 2 years, were taking any medication or supplement that might affect weight or taste, diagnosed as bulimia nervosa, a history of anorexia nervosa, taste disorders, a history of sinusitis and presenting sinus problem, presented such illness that may affect weight as malignancy or endocrine disease, have been during obstructive sleep apnea syndrome(OSAS)or psychiatry disease treatment, have schedule of move during the research period(8 months), and those who are judged inadequate by responsible doctor for any reason.

Target sample size

112


Research contact person

Name of lead principal investigator

1st name Takehiro
Middle name
Last name Nozaki

Organization

Kyushu University

Division name

Department of Psychosomatic medicine

Zip code

8128582

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka city, Fukuoka, Japan

TEL

0926425318

Email

takano.hidemi.688@m.kyushu-u.ac.jp


Public contact

Name of contact person

1st name Takehiro
Middle name
Last name Nozaki

Organization

Kyushu University

Division name

Department of Psychosomatic medicine

Zip code

8128582

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka city, Fukuoka, Japan

TEL

092-642-5318

Homepage URL


Email

takano.hidemi.688@m.kyushu-u.ac.jp


Sponsor or person

Institute

Kyushu University Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyushu University ARO center

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka-citu, Fukuoka

Tel

0926426290

Email

tr-info@med.kyushu-u.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

九州大学病院(福岡県)


Other administrative information

Date of disclosure of the study information

2017 Year 12 Month 19 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2017 Year 11 Month 07 Day

Date of IRB

2017 Year 11 Month 07 Day

Anticipated trial start date

2017 Year 12 Month 16 Day

Last follow-up date

2026 Year 06 Month 30 Day

Date of closure to data entry

2026 Year 12 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 12 Month 18 Day

Last modified on

2024 Year 02 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034741


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name