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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02180802
Other study ID # 3287
Secondary ID
Status Completed
Phase N/A
First received July 1, 2014
Last updated August 30, 2014
Start date February 2011
Est. completion date April 2013

Study information

Verified date August 2014
Source Qazvin University Of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

Motivational interviewing (MI) has been shown to be an effective strategy in targeting obesity in adolescents and parental involvement has been associated with increased effectiveness. The aim of the study is to evaluate and compare the role of parental involvement in MI interventions for obese adolescents


Recruitment information / eligibility

Status Completed
Enrollment 408
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group 13 Years to 18 Years
Eligibility Inclusion Criteria:

- BMI equal or higher than 95th percentile for age and gender

- 13-18 years old

Exclusion Criteria:

- medication with weight gain as side effects

- diagnosed with having eating disorder

- pregnant

- clinical mental health conditions

- psychosis

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
motivational interviewing

motivational interviewing with parental involvement

Control group


Locations

Country Name City State
Iran, Islamic Republic of Outpatient Pediatric Clinic Qazvin

Sponsors (1)

Lead Sponsor Collaborator
Qazvin University Of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary changes in BMI Body Mass Index changes from baseline and 12 months follow-up Yes
Primary Child Dietary Self-Efficacy Child Dietary Self-Efficacy Scale (CDSS) changes from baseline and 12 months follow-up Yes
Primary Weight Efficacy Lifestyle Weight Efficacy Lifestyle questionnaire (WEL) changes from baseline and 12 months follow-up Yes
Primary Physical Exercise Self-efficacy Physical Exercise Self-efficacy Scale (PES) changes from baseline and 12 months follow-up Yes
Primary changes in physical activity changes from baseline and 12 months follow-up Yes
Primary changes in dietary pattern changes from baseline and 12 months follow-up Yes
Secondary Changes in blood cholesterol level changes from baseline and 12 months follow-up Yes
Secondary changes in blood triglyceride level changes from baseline and 12 months follow-up Yes
Secondary Changes in body fat percentage changes from baseline and 12 months follow-up Yes
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