Determine The effect of mindfulness based eating counseling on weight gain during pregnancy in overweight pregnant women
Design
A randomized controlled trial, randomized block design with block size 4, Sample size was 94 persons.
Settings and conduct
The sampling point is the health centers of east of Ahvaz. Women who are between 12 and 20 weeks pregnant with BMI between 25 and 34.9 are invited by telephone to participate in the study. a briefing is to be held and After obtaining written consent and ensuring confidentiality of information, The Mundful Eating Questionnaire is completed by people who have the criteria for entering the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:1- being pregnant 2- before or early pregnancy BMI between 25 and 34.9 3- pregnancy age between 12 and 20 weeks 4- single pregnancy 5- get an average score of less than 3 out of 5 on the mindful eating questionnaire 6- willingness to participate in the study 7- reading and writing skills
Exclusion criteria: 1- the mother has chronic illnesses and medical conditions requiring medical interventions 2- high risk pregnancy ( preeclampsia, gestational diabetes, placenta previa and twin pregnancy) 3- A mother's history of depression 4- Addiction to drugs such as psychotropic and stimulants, alcohol, cigarettes and tobacco 5- Have regular exercise programs to lose weight
Intervention groups
Both intervention and control groups will receive dietary advice and routine recommendations used in health centers for overweight pregnant women and intervention group participants, in addition to that, 6 sessions of mindful eating group counseling will be held once a week for two hours.
Main outcome variables
Weight gain during pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191018045147N1
Registration date:2020-01-19, 1398/10/29
Registration timing:prospective
Last update:2020-01-19, 1398/10/29
Update count:0
Registration date
2020-01-19, 1398/10/29
Registrant information
Name
Elnaz Beiranvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3322 0424
Email address
beiranvand.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-22, 1398/11/02
Expected recruitment end date
2020-06-18, 1399/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness based eating counseling on weight gain during pregnancy in overweight pregnant women
Public title
The effect of mindfulness based eating counseling on weight gain during pregnancy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
being pregnant
before or early pregnancy BMI between 25 and 34.9
pregnancy age between 12 and 20 weeks
single pregnancy
get an average score of less than 3 out of 5 on the mindful eating questionnaire
willingness to participate in the study
reading and writing skills
Exclusion criteria:
the mother has chronic illnesses and medical conditions requiring medical interventions
high risk pregnancy ( preeclampsia, gestational diabetes, placenta previa and twin pregnancy)
A mother's history of depression
Addiction to drugs such as psychotropic and stimulants, alcohol, cigarettes and tobacco
Have regular exercise programs to lose weight
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Method of assigning intervention to patients, Randomly and by random permutation blocks with block size 4 (using table of random permutations) . The randomization list is compiled by a statistics expert. Each patient will be evaluate for inclusion criteria and, if eligible, was randomly assigned to one of two study groups (control, intervention).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ethics committee of Ahvaz University of Medical Sciences, Golestan Hwy
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Approval date
2019-11-08, 1398/08/17
Ethics committee reference number
IR.AJUMS.REC.1398.573
Health conditions studied
1
Description of health condition studied
weight gain during pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Weight gain during pregnancy
Timepoint
Weight was measured before the study, after the intervention, one month and two months after the intervention
Method of measurement
scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Participants in the control group will receive dietary advice and routine recommendations used in health centers for overweight pregnant women.
Category
N/A
2
Description
Intervention group:For the intervention group, in addition to dietary advice and routine recommendations used in health centers in the country, 6 sessions of mindful eating group counseling will be held once a week for two hours.Weight measurement and completing the Mindful Eating Questionnaire will be performed before the intervention, after the intervention, one month later, and two months after the intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
East Health Center of Ahvaz
Full name of responsible person
Ahmed Meshkurnia
Street address
In front of Haft Tir Park, Shahid Rastegari St, Ayatollah Behbahani Hwy
City
Ahvaz
Province
Khouzestan
Postal code
6173663369
Phone
+98 61 3373 8383
Email
info@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Muhammad Badavi
Street address
Ahvaz University of Medical Sciences, Golestan hwy
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3373 8383
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nahid Javadifar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz University of Medical Sciences, Golestan hwy
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3373 8331
Email
nahidjavadifar_341@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nahid Javadifar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz University of Medical Sciences, Golestan hwy
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3373 8331
Email
nahidjavadifar_341@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Elnaz Beiranvand
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ahvaz University of Medical Sciences, Golestan hwy
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3373 8331
Email
Elnaz.by70@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available