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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012235
Receipt No. 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

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

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
URL(English) https://upload.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


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