Effect of Motivational Interviewing (MI) to Improve Physiological Indicators and Cardio-respiratory Fitness among Overweight and Obese Women who attended to nutrition clinics
Background and Aim: Obesity has dramatically becomes a public health problem across the world. The current survey explored the effects of motivational interviewing (MI) on physiological parameters and cardio-respiratory fitness among women with overweight and obesity who attended to nutrition clinics.
Materials and Methods: We conducted a single-blind randomized clinical trial study on 64 women with overweight and obesity randomly assigned to MI (n=32) or control (n= 32) group. The Rockport Walk Test was used to evaluate VO2 max, LDL-C, HDL-C and total cholesterol were also tested in subjects trained to fast for 12 hours and avoid alcohol consumption in 24 hours before blood test. The total cholesterol, LDL-C, HDL-C and cardio-respiratory fitness were investigated at baseline and at 12 months follow-up. Descriptive analysis was run to describe the mean and standard deviation of the demographic characteristics.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062217736N8
Registration date:2016-07-01, 1395/04/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-01, 1395/04/11
Registrant information
Name
Seyed Kamaladdin Mirkarimi
Name of organization / entity
Golestan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 17 1553 2872
Email address
k.mirkarimi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Science
Expected recruitment start date
2014-09-27, 1393/07/05
Expected recruitment end date
2015-10-01, 1394/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Motivational Interviewing (MI) to Improve Physiological Indicators and Cardio-respiratory Fitness among Overweight and Obese Women who attended to nutrition clinics
Public title
Effect of Motivational Interviewing (MI) to Improve Physiological Indicators and Cardio-respiratory Fitness
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria were as follow: 1) hyperlipidemia diagnosed by a fasting LDL-C (130 mg/dl or higher), 2) ability to read, 3) access to a telephone, 4) no history of nutritional intervention such as motivational interviewing, and 5) no history of drug use (drugs for controlling cholesterol, LDL and HDL).
Exclusion criterion was as follow: participants with absence more than two sessions (standard and MI) .
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
1
Registry name
خیر
Secondary trial Id
خیر
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan University of Medical Science
Street address
Kilometer 4 Gorgan-Sari Road, Educational campus of Falsafi,Vice Chancellor for Research, Gorgan City, Golestan Province, Iran
City
Gorgan
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
920807108
Health conditions studied
1
Description of health condition studied
Hyperlipidemia
ICD-10 code
E78.6
ICD-10 code description
Lipoprotein deficiency
Primary outcomes
1
Description
Cholesterol, HDL-C, LDL-C
Timepoint
Baseline and 12 months follow-up
Method of measurement
Fasting Blood Sugar (FBS)
Secondary outcomes
1
Description
cardio-respiratory fitness
Timepoint
Baseline and 12 Months follow-up
Method of measurement
Rockport Walk test
Intervention groups
1
Description
Motivational interviewing group: they were educated using written materials including pamphlet and brochure in terms of (a) behaviors that may decrease cholesterol (b) the components of LDL-C and HDL-C (c) a definition of cholesterol (d) some of usual misconceptions in terms of cholesterol (e) the principle components of a healthy diet for the heart (f) basic dietary guidelines [15] (g) the role of physical activity and dietary fats in reducing cholesterol (h) shopping and food preparation tips (i) an exercise plan.
This arm was provided by five sessions of MI with a psychologist based on seven key points of MI 3 weeks after the first intervention (written material). In overall, between 8 and 12 subjects participated in each session (each session consisted of 30 to 45 minutes). These steps were as follow: (a) people motivate and persuade to change, voluntarily; (b) it is the client's role to resolve their ambivalence; (c) direct persuasion is not a beneficial technique to resolve ambivalence; (d) the counselor is a directive method to help clients to explore and resolve ambivalence; (e) the counseling style is a eliciting and quiet approach; (f) readiness to change is a fluctuating product of interpersonal interaction and (g) the therapeutic relation was more similar to a partnership than expert- recipient roles
Category
Prevention
2
Description
Control group was educated using written materials including pamphlet and brochure in terms of (a) behaviors that may decrease cholesterol (b) the components of LDL-C and HDL-C (c) a definition of cholesterol (d) some of usual misconceptions in terms of cholesterol (e) the principle components of a healthy diet for the heart (f) basic dietary guidelines [15] (g) the role of physical activity and dietary fats in reducing cholesterol (h) shopping and food preparation tips (i) an exercise plan. in the control group received five follow-up telephone session 3 weeks after the first intervention (written material). This session was 30 to 45 minutes and was also delivered by an instructed person to adhere to the script provided.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Private Nutrition clinic
Full name of responsible person
Street address
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University of Medical Science
Full name of responsible person
Mohammad Parang
Street address
Vice Chancellor of Information and Technology, Educational campus of Falsafi, Kilometer 4 Gorgan-Sari Road, Gorgan City, Golestan Province
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Golestan University of Medical Science
Full name of responsible person
Seyyed Kamal Mirkarimi
Position
Ph.D of Health Education and Promotion
Other areas of specialty/work
Street address
No 19- 3rd Alley- 57Avenue- Gorgan City- Golestan Province- Iran
City
Gorgan
Postal code
4917
Phone
+98 17 3242 4377
Fax
Email
ak.mirkarimi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Science
Full name of responsible person
Seyyed Kamal Mirkarimi
Position
Ph.D of Health Education and Promotion
Other areas of specialty/work
Street address
No 19- 3rd Alley- 57Avenue- Gorgan City- Golestan Province- Iran