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IRCT20200919048767N1 IRCT 2020-11-18 Islamic Azad University Effect of mindfulness training on weight loss MB_EAT Comparison of effectiveness of mindfulness- based eating awareness training (MB-EAT) and its integration with the implementation intentions on weight loss and biological, psychological and behavioral indices in women with obesity 2020-10-22 anticipated 45 Complete https://irct.ir/trial/51071 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Factorial, Purpose: Education/Guidance, Other design features: Implamentation intention is integrated with mindfulness-based eating awareness training as a program to implement the goals of change, Randomization description: 1. After equalizing people in weight, age and waist circumference, we put them in three groups. 2. Each intervention is named with the English letters A, B, C. 3. Write the letters A, B, C inside the three envelopes and mix them so that it is not clear what is in each envelope. 4.By asking one person from each category to enter the study, we tell them to take one of the envelopes randomely and according to the letter, that person will be placed in one of the groups. 5.For the fourth to sixth participants, we repeat step 4, and then for the next three people, etc., until the required number of samples is completed in all three groups. N/A Obesity. Intervention 1: Intervention group 1: Mindful based eating awareness training will be done for 12 sessions, one session per week and each session for 2 and a half hours according to the training instructions. Participants will be introduced to the concepts of inner wisdom and outer wisdom. Inner wisdom, wise use of: Awareness of physical hunger and fullness, eating triggers, emotions and thoughts/ Self-acceptance. Outer Wisdom: wise use of nutrition and calories/activity-exercise Information. At the end of each session, group participants are asked to practice the trained techniques to turn this knowledge into a wisdom and become a lifestyle. Intervention 2: Intervention group 2: This group, just like experimental group 1 receives mindfulness-based eating awareness training. At the end of each session, they are asked to do the practices and techniques they have learned to become a lifestyle, according to implementation Intention, the therapist will write a practical plan for how to count calories, healthy eating and physical activity, and asks them to have a high commitment to performing these three components on a daily basis and to report their practice virtually. Intervention 3: Control group: Simultaneously with the experimental groups, they will receive information about obesity and overweight. After the end of the intervention and follow-up; to observe the treatment ethics, the intervention will be performed for this group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The output of the data and software and the consequences of the intervention will be provided as a Spss file, so there is no need to publish it.
public Mona Jassemi Zergani
NO. 30, Mohammadali Keshaverz Ave; Saadat Abad.
Tehran Iran (Islamic Republic of) 1998669711 +98 21 2641 9061 mjassemi@yhoo.com Islamic Azad University scientific Mona Jassemi Zergani
NO. 30, Mohammadali Keshaverz Ave; Saadat Abad.
Tehran Iran (Islamic Republic of) 1998669711 +98 21 2641 9061 mjassemi@yhoo.com Islamic Azad University Iran (Islamic Republic of) BMI ≥ 25 Gender: Female Age:20 years and older Education: Diploma and higher. 20 years no limit Female Receive concomitant psychotherapy or other regular weight loss and exercise programs Use of psychotropic or weight-affecting drugs. Having a mental disorder Hypothyroidism Pregnancy Diabetes E66 Overweight and obesity Lifestyle Lifestyle Placebo Intervention group 1: Mindful based eating awareness training will be done for 12 sessions, one session per week and each session for 2 and a half hours according to the training instructions. Participants will be introduced to the concepts of inner wisdom and outer wisdom. Inner wisdom, wise use of: Awareness of physical hunger and fullness, eating triggers, emotions and thoughts/ Self-acceptance. Outer Wisdom: wise use of nutrition and calories/activity-exercise Information. At the end of each session, group participants are asked to practice the trained techniques to turn this knowledge into a wisdom and become a lifestyle. Intervention group 2: This group, just like experimental group 1 receives mindfulness-based eating awareness training. At the end of each session, they are asked to do the practices and techniques they have learned to become a lifestyle, according to implementation Intention, the therapist will write a practical plan for how to count calories, healthy eating and physical activity, and asks them to have a high commitment to performing these three components on a daily basis and to report their practice virtually. Control group: Simultaneously with the experimental groups, they will receive information about obesity and overweight. After the end of the intervention and follow-up; to observe the treatment ethics, the intervention will be performed for this group. Weight. Timepoint: Before the study and after that (3 months later) and 3 and 6 months later for follow-up. Method of measurement: weight of digital scales. Cholesterol. Timepoint: Before the intervention and 3 and 6 months after the intervention. Method of measurement: Blood samples after 12 hours of fasting using laboratory kits. Triglycerid. Timepoint: Before the intervention and 3 and 6 months after the intervention. Method of measurement: Blood samples after 12 hours of fasting using laboratory kits. High density lipoprotein(HDL). Timepoint: Before the intervention and 3 and 6 months after the intervention. Method of measurement: Blood samples after 12 hours of fasting using laboratory kits. Low density lipoprotein(LDL). Timepoint: Before the intervention and 3 and 6 months after the intervention. Method of measurement: Blood samples after 12 hours of fasting using laboratory kits. Fasting blood sugar(FBS). Timepoint: Before the intervention and 3 and 6 months after the intervention. Method of measurement: Blood samples after 12 hours of fasting using laboratory kits. Waist circumference. Timepoint: Before the intervention and 3 and 6 months after the intervention. Method of measurement: The narrowest waist area with tape measure (accuracy 0.5 cm). Self-efficacy. Timepoint: Before the intervention and 3 and 6 months after the intervention. Method of measurement: weight efficacy lifestyle questionnaire. Eating behavior. Timepoint: Before the intervention and 3 and 6 months after the intervention. Method of measurement: Three Factor Eating Questionnaire. Mindful eating. Timepoint: Before the intervention and 3 and 6 months after the intervention. Method of measurement: Mindful Eating Questionnaire. Emotional eating. Timepoint: Before the intervention and 3 and 6 months after the intervention. Method of measurement: Difficulties in Emotion Regulation Scale( (DERS). Calorie counting. Timepoint: Before the intervention and 3 and 6 months after the intervention. Method of measurement: check list. Physical activity. Timepoint: Before the intervention and 3 and 6 months after the intervention. Method of measurement: check list. Healthy diet. Timepoint: Before the intervention and 3 and 6 months after the intervention. Method of measurement: check list. Islamic Azad University Approved 2020-09-16 Ethics Committee of the School of Nursing and Midwifery, Karaj Azad University Faculty of Nursing and Midwifery, Islamic Azad University, Karaj, Rajai Shahr Karaj Alborz Iran (Islamic Republic of)