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Parental Involvement Improves the Effect of Motivational Interviewing on Weight Loss in Obese Adolescents: A Randomized Controlled Trial Study

Primary Purpose

Obesity, Adolescent

Status

Completed

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

motivational interviewing

motivational interviewing with parental involvement

Control group

About this trial

This is an interventional prevention trial for Obesity, Adolescent focused on measuring obese adolescents, BMI ≥ 95th percentile for age and gender

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outpatient Pediatric Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

motivational intervieing group

motivational interviewi group with parental involvement

Control

Arm Description

The behavioral intervention targets were improved eating and physical activity behavior in order to reduce obesity levels. Each adolescent was encouraged to eat a variety of foods from each of the four major food groups and low-fat alternatives . Moreover, each adolescent was encouraged to achieve at least 60 minutes of moderate-to-vigorous intensity physical activity daily as recommended by the World Health Organization

an additional single session with parents or guardians over 60 minutes in the clinic

The patients received routine care

Outcomes

Primary Outcome Measures

changes in BMI

Body Mass Index

Child Dietary Self-Efficacy

Child Dietary Self-Efficacy Scale (CDSS)

Weight Efficacy Lifestyle

Weight Efficacy Lifestyle questionnaire (WEL)

Physical Exercise Self-efficacy

Physical Exercise Self-efficacy Scale (PES)

changes in physical activity

changes in dietary pattern

Secondary Outcome Measures

Changes in blood cholesterol level

changes in blood triglyceride level

Changes in body fat percentage

Full Information

NCT ID

NCT02180802

First Posted

July 1, 2014

Last Updated

August 30, 2014

Sponsor

Qazvin University Of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02180802

Brief Title

Parental Involvement Improves the Effect of Motivational Interviewing on Weight Loss in Obese Adolescents: A Randomized Controlled Trial Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Qazvin University Of Medical Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Adolescent

Keywords

obese adolescents, BMI ≥ 95th percentile for age and gender

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

408 (Actual)

8. Arms, Groups, and Interventions

Arm Title

motivational intervieing group

Arm Type

Experimental

Arm Description

Arm Title

motivational interviewi group with parental involvement

Arm Type

Experimental

Arm Description

an additional single session with parents or guardians over 60 minutes in the clinic

Arm Title

Control

Arm Type

Active Comparator

Arm Description

The patients received routine care

Intervention Type

Behavioral

Intervention Name(s)

motivational interviewing

Intervention Type

Behavioral

Intervention Name(s)

motivational interviewing with parental involvement

Intervention Type

Behavioral

Intervention Name(s)

Control group

Primary Outcome Measure Information:

Title

changes in BMI

Description

Body Mass Index

Time Frame