Examining the Effectiveness of the Acceptance and Commitment Therapy Matrix for Health Behaviors on Obese People
Design
Multiple Baseline Design Across Individuals with Follow-up
Settings and conduct
The study was conducted on four obese people. These people were selected via consecutive sampling and randomly assigned in four series with different baseline phase Length (3 to 6 weeks). The self-report assessments in the baseline phase were conducted weekly, in the intervention phase were conducted before session 3, session 5, session 7, session 9, session 11, and after session 12, and in the follow-up phase were conducted one and three months after the intervention. The intervention and assessment were conducted online.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: People aged 18-50; BMI ≥ 30; Diploma and higher education
Exclusion Criteria: suffering from mood disorders; suffering from anxiety disorders; suffering from eating disorders; using psychiatric drugs and/or fat burner supplements; suffering from cardiovascular disease; suffering from diabetes; suffering from thyroid problems; suffering from respiratory problems; suffering from gastroenteric problems; receiving psychotherapy or another program for weight loss; Pregnancy; Planning for pregnancy; Menopause; Dietary Choices (DC) subscale score > 1.2; Physical Activity (PA) subscale score > 1.2
Intervention groups
Four people with obesity were received indivitually Acceptance and Commitment Therapy Matrix intervention for health behaviors.
Main outcome variables
Healthy Eating Behavior; Exercise Behavior
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191102045309N1
Registration date:2021-10-13, 1400/07/21
Registration timing:retrospective
Last update:2021-10-13, 1400/07/21
Update count:0
Registration date
2021-10-13, 1400/07/21
Registrant information
Name
Saman Nonahal
Name of organization / entity
Kharazmi University
Country
Iran (Islamic Republic of)
Phone
+98 17 3252 6398
Email address
nonahal.saman@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-07-05, 1399/04/15
Actual recruitment start date
2020-06-21, 1399/04/01
Actual recruitment end date
2020-07-05, 1399/04/15
Trial completion date
2020-10-26, 1399/08/05
Scientific title
Examining the Effectiveness of the Acceptance and Commitment Therapy Matrix for Health Behaviors on Obese People
Public title
Examining the Effectiveness of the Acceptance and Commitment Therapy Matrix on Health Behaviors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People aged 18-50
Body Mass Index (BMI) ≥ 30
Diploma and higher education
Exclusion criteria:
suffering from mood disorders
suffering from anxiety disorders
suffering from eating disorders
using psychiatric drugs and/or fat burner supplements
suffering from cardiovascular disease
suffering from diabetes
suffering from thyroid problems
suffering from respiratory problems
suffering from gastroenteric problems
receiving psychotherapy or other program for weight loss
Pregnancy
Planning for pregnancy
Menopause
Dietary Choices (DC) subscale score > 1.2
Physical Activity (PA) subscale score > 1.2
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
4
Actual sample size reached:
4
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kharazmi University
Street address
No.43, South Mofatteh Ave.
City
Tehran
Province
Tehran
Postal code
15719-14911
Approval date
2020-05-26, 1399/03/06
Ethics committee reference number
IR.KHU.REC.1399.006
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Healthy Eating Behavior Score in the Weight Control Strategies Scale
Timepoint
3-6 times weekly during the baseline phase, before session 3, session 5, session 7, session 9, session 11, and after session 12 during the intervention phase, and one and three months after the intervention during the follow-up phase
Method of measurement
Dietary Choices subscale in the Weight Control Strategies Scale
2
Description
Exercise Behavior Score in the Weight Control Strategies Scale
Timepoint
3-6 times weekly during the baseline phase, before session 3, session 5, session 7, session 9, session 11, and after session 12 during the intervention phase, and one and three months after the intervention during the follow-up phase
Method of measurement
Physical Activity subscale in the Weight Control Strategies Scale
Secondary outcomes
1
Description
Emotional Eating Score in the Three Factor Eating Questionnaire-R18
Timepoint
3-6 times weekly during the baseline phase, before session 3, session 5, session 7, session 9, session 11, and after session 12 during the intervention phase, and one and three months after the intervention during the follow-up phase
Method of measurement
Emotional Eating subscale in the Three Factor Eating Questionnaire-R18
2
Description
External Eating Score in the Dutch Eating Behaviour Questionnaire
Timepoint
3-6 times weekly during the baseline phase, before session 3, session 5, session 7, session 9, session 11, and after session 12 during the intervention phase, and one and three months after the intervention during the follow-up phase
Method of measurement
External Eating subscale in the Dutch Eating Behaviour Questionnaire
3
Description
Food Craving Acceptance Score in the Food Craving Acceptance and Action Questionnaire
Timepoint
3-6 times weekly during the baseline phase, before session 3, session 5, session 7, session 9, session 11, and after session 12 during the intervention phase, and one and three months after the intervention during the follow-up phase
Method of measurement
Acceptance subscale in the Food Craving Acceptance and Action Questionnaire
4
Description
Healthy Eating with Willingness Score in the Food Craving Acceptance and Action Questionnaire
Timepoint
3-6 times weekly during the baseline phase, before session 3, session 5, session 7, session 9, session 11, and after session 12 during the intervention phase, and one and three months after the intervention during the follow-up phase
Method of measurement
Willingness subscale in the Food Craving Acceptance and Action Questionnaire
5
Description
Physical Activity Acceptance Score in the Physical Activity Acceptance Questionnaire
Timepoint
3-6 times weekly during the baseline phase, before session 3, session 5, session 7, session 9, session 11, and after session 12 during the intervention phase, and one and three months after the intervention during the follow-up phase
Method of measurement
Cognitive Acceptance subscale in the Physical Activity Acceptance Questionnaire
6
Description
Physical Activity Commitment Score in the Physical Activity Acceptance Questionnaire
Timepoint
3-6 times weekly during the baseline phase, before session 3, session 5, session 7, session 9, session 11, and after session 12 during the intervention phase, and one and three months after the intervention during the follow-up phase
Method of measurement
Behavioral Commitment subscale in the Physical Activity Acceptance Questionnaire
7
Description
Self-Compassion Score in the Self-Compassion Scale
Timepoint
3-6 times weekly during the baseline phase, before session 3, session 5, session 7, session 9, session 11, and after session 12 during the intervention phase, and one and three months after the intervention during the follow-up phase
Method of measurement
Self-Compassion Scale
8
Description
Valued Living Score in the Valuing Questionnaire
Timepoint
3-6 times weekly during the baseline phase, before session 3, session 5, session 7, session 9, session 11, and after session 12 during the intervention phase, and one and three months after the intervention during the follow-up phase
Method of measurement
Valuing Questionnaire
Intervention groups
1
Description
Intervention group: In a multiple baseline design across individuals with follow-up, four obese people participated. The 12 session intervention was conduct weekly, individually, and online. The intervention was developed based on the six-step approach of the Acceptance and Commitment Therapy Matrix.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Instagram
Full name of responsible person
Saman Nonahal
Street address
-
City
-
Province
Golestan
Postal code
-
Phone
+98 17 3252 9260
Email
Nonahal.Saman@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kharazmi University
Full name of responsible person
jamshid shanbehzadeh
Street address
Floor 10, No.43, Bldg 11, South Mofatteh Ave.
City
Tehran
Province
Tehran
Postal code
۳۷۵۵۱-۳۱۹۷۹
Phone
+98 21 8607 0779
Email
research@khu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After deleting the confidential information, participants' data file in this study, including demographic and intervention information, is sharing with other researchers and practitioners.
When the data will become available and for how long
Access period starts 3 months after publishing the results
To whom data/document is available
The data is only available to colleagues and other researchers and practitioners.
Under which criteria data/document could be used
The data can be used for publication in scientific journals. Researchers are not allowed to do any analysis, and they can only view and receive the data. Researchers are also required to make a written commitment not to publish the data file.
From where data/document is obtainable
Send an email to Saman Nonahal: Nonahal.Saman@gmail.com
What processes are involved for a request to access data/document
After sending an email to Saman Nonahal, confirming the identity of the applicant, and the final confirmation of the colleagues, the data will be sent to them. The approximate time will be 2 to 3 months