UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012235
Receipt number R000014305
Scientific Title Reporting the results of a Stress Management intervention for weight loss in former bariatric patients with weight management problems: A Pilot, Randomized Controlled Trial
Date of disclosure of the study information 2013/11/07
Last modified on 2013/11/07 18:59:44

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Reporting the results of a Stress Management intervention for weight loss in former bariatric patients with weight management problems: A Pilot, Randomized Controlled Trial

Acronym

Stress Management intervention for weight loss in former bariatric patients: A Pilot, Randomized Controlled Trial

Scientific Title

Reporting the results of a Stress Management intervention for weight loss in former bariatric patients with weight management problems: A Pilot, Randomized Controlled Trial

Scientific Title:Acronym

Stress Management intervention for weight loss in former bariatric patients: A Pilot, Randomized Controlled Trial

Region

Europe


Condition

Condition

Weight management problems in former bariatric patients.

Classification by specialty

Surgery in general Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effectiveness of a stress management intervention in weight loss of former bariatric patients, with weight regain.

Basic objectives2

Others

Basic objectives -Others

The examined hypotheses were that the stress management - based program would produce greater weight and fat loss, more favorable alterations in body circumferences, reductions in stress, anxiety, and depression level, as well as better eating attitudes, than the non treatment approach.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Anthropometric measurements were taken before and after the intervention.

Key secondary outcomes

The participants completed the following questionnaires: Eating Attitudes Test (EAT-26), Depression, Anxiety, Stress Scales (DASS-21) and Perceived Stress Scale (PSS-14) before and after the intervention.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom Other

Interventions/Control_1

Nutritional education, physical activity, behavioral and stress management.

Interventions/Control_2

Nutritional education and physical activity.

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

18 years-old <

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Bariatric surgery record and present weight regain; self-reported Greek fluency.

Key exclusion criteria

Inability to participate in the intervention program because of any reasons; pregnancy and lactation.

Target sample size

46


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Iliana Michali

Organization

Athens University Medical School

Division name

Postgraduate M.Sc. Course in Stress Management and Health Promotion

Zip code


Address

Il. Apostolou 36, N. Irakleio, 14121, Greece

TEL

+81-0306973654887

Email

ilianamichali@yahoo.gr


Public contact

Name of contact person

1st name
Middle name
Last name Iliana Michali

Organization

Athens University Medical School

Division name

Postgraduate M.Sc. Course in Stress Management and Health Promotion

Zip code


Address

Il. Apostolou 36, N. Irakleio, 14121, Greece

TEL

+81-0306973654887

Homepage URL


Email

ilianamichali@yahoo.gr


Sponsor or person

Institute

Postgraduate M.Sc. Course in Stress Management and Health Promotion

Institute

Department

Personal name



Funding Source

Organization

No funding received.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

Bariatric Surgery Clinic, 1st Department of Internal Surgery, University of Athens Medical School, Athens, Greece.


Other administrative information

Date of disclosure of the study information

2013 Year 11 Month 07 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

A total of 34 ex-bariatric patients with mean (SD) weight regain of 16,2 (8,3) kg and mean (SD) age of 41,7 (9) years were randomly assigned into an 8-week stress management based behavioral weight loss intervention (IG) or in a control group. The findings indicated a significant reduction in weight (Mdn=2,3kg, Min= -4,2kg, Max=6kg), fat (Mdn=1,7kg, Min=-1,90kg, Max=7kg), waist (Mdn=3,9cm, Min=-2,3cm, Max=20,5cm) and hip circumference (Mdn=3,7cm, Min=-3,9cm, Max=23,9cm) in the IG after intervention compared to the CG (Mdn=0kg, Min=-1,8kg, Max=4,7kg), (Mdn=0,4kg, Min=-3,3kg, Max=20,5kg), (Mdn=0,2cm, Min=-5cm, Max=10cm) and (Mdn=0,1cm, Min=-1,7cm, Max=2cm) (P < 0.05). A lower dieting and bulimia attitude were observed in the IG after intervention compared to the CG, although there was no significant difference in anxiety, depression and stress levels.

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

Completed

Date of protocol fixation

2012 Year 11 Month 30 Day

Date of IRB


Anticipated trial start date

2013 Year 03 Month 01 Day

Last follow-up date

2013 Year 08 Month 08 Day

Date of closure to data entry

2013 Year 08 Month 08 Day

Date trial data considered complete

2013 Year 08 Month 08 Day

Date analysis concluded

2013 Year 08 Month 08 Day


Other

Other related information



Management information

Registered date

2013 Year 11 Month 07 Day

Last modified on

2013 Year 11 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014305


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name