UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049041 |
|---|---|
| Receipt number | R000055850 |
| Scientific Title | Factors associated with improvement of the body image dissatisfaction of female patients with overweight and obesity during cognitive behavioral therapy |
| Date of disclosure of the study information | 2022/09/28 |
| Last modified on | 2023/12/05 10:35:08 |
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Basic information
Public title
Factors associated with improvement of the body image dissatisfaction of female patients with overweight and obesity during cognitive behavioral therapy
Acronym
Factors associated with improvement of the body image dissatisfaction of female patients with overweight and obesity during cognitive behavioral therapy
Scientific Title
Factors associated with improvement of the body image dissatisfaction of female patients with overweight and obesity during cognitive behavioral therapy
Scientific Title:Acronym
Factors associated with improvement of the body image dissatisfaction of female patients with overweight and obesity during cognitive behavioral therapy
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine factors associated with improvement of the body image dissatisfaction of female patients with overweight and obesity during cognitive behavioral therapy
Basic objectives2
Others
Basic objectives -Others
To examine psychological and eating-related factors associated with improvement of the body image dissatisfaction of female patients with overweight and obesity during cognitive behavioral therapy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To identify psychological and eating-related factors associated with improvement of the body image dissatisfaction of female patients with overweight and obesity during cognitive behavioral therapy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Female
Key inclusion criteria
1.Womnan aged 20 to 65 years old
2.25<=BMI<45
3.Woman who can fulfill questionnaire by herself
4.Woman who can do brief mat exercise
Key exclusion criteria
1.Weight loss over 5kg in the past 6 months
2.Bulimia nervosa
3.Anorexia nervosa
4.Pregnant or breast feeding woman or planning to be pregant in the following 2 years
5.Takin medicine or suppliment which can affect body weight
6.Having deseases which can affect body weight ,such as cancer or endocrine diseases
7.Recieving treatment for OSAS
8.Recieving treatment for mental diseases
9.Planning to move in the following 10 months
Target sample size
204
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Nozaki |
Organization
Nakamura Gakuen University
Division name
Graduate School of Nutritional Sciences
Zip code
814-0198
Address
5-7-1, Befu, Minami-ku, Fukuoka-shi, Fukuoka
TEL
092-851-2663
takehiro.nozaki.425@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Yokoyama |
Organization
Kyushu University
Division name
Psychosomatic medicine
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka,Japan
TEL
092-642-5318
Homepage URL
yokoyama.hiroaki.211@s.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Psychosomatic Medicine, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of Psychosomatic Medicine, Kyushu University
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
Institutional Review Board of Kyushu University
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
Tel
092-642-6772
ijkseimei@jimu.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 28 | Day |
Related information
URL releasing protocol
https://www.frontiersin.org/articles/10.3389/fpsyt.2022.1025946/full
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/articles/10.3389/fpsyt.2022.1025946/full
Number of participants that the trial has enrolled
165
Results
Percent total weight loss, baseline body image dissatisfaction (BID), baseline binge eating, change in depression (delta depression), delta state anxiety, delta trait anxiety, delta binge eating, and delta perfectionism were significantly correlated with delta BID.
Multiple regression analysis showed that baseline BID, baseline binge eating, percent total weight loss, delta binge eating, and delta depression were independently associated with delta BID.
Results date posted
| 2023 | Year | 12 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
People with overweight (n = 73) or obesity (n = 92) who joined and completed our CBT-based weight loss treatment between 2012 and 2019 at the outpatient clinic for obesity of the Department of Psychosomatic Medicine at Kyushu University Hospital.
Participant flow
We recruited participants through the local newspaper, the university website, posters in the university hospital or hospitals near the university and a television program. Those who were interested and potentially eligible were scheduled for an information session to learn more about the study. At the information session, the principal investigator provided the details of the study and answered questions from the participants. Those who met the eligibility criteria were enrolled in the study and informed consent was obtained.
Adverse events
none
Outcome measures
Factors associated with improvement of body image dissatisfaction during cognitive behavioral therapy
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective study based on data from a previously completed clinical studies.
Management information
Registered date
| 2022 | Year | 09 | Month | 27 | Day |
Last modified on
| 2023 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055850
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