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

August 30, 2014 updated by: Amir H Pakpour, Qazvin University Of Medical Sciences
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

Study Overview

Study Type

Interventional

Enrollment (Actual)

408

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: motivational intervieing group
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
Experimental: motivational interviewi group with parental involvement
an additional single session with parents or guardians over 60 minutes in the clinic
Active Comparator: Control
The patients received routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in BMI
Time Frame: changes from baseline and 12 months follow-up
Body Mass Index
changes from baseline and 12 months follow-up
Child Dietary Self-Efficacy
Time Frame: changes from baseline and 12 months follow-up
Child Dietary Self-Efficacy Scale (CDSS)
changes from baseline and 12 months follow-up
Weight Efficacy Lifestyle
Time Frame: changes from baseline and 12 months follow-up
Weight Efficacy Lifestyle questionnaire (WEL)
changes from baseline and 12 months follow-up
Physical Exercise Self-efficacy
Time Frame: changes from baseline and 12 months follow-up
Physical Exercise Self-efficacy Scale (PES)
changes from baseline and 12 months follow-up
changes in physical activity
Time Frame: changes from baseline and 12 months follow-up
changes from baseline and 12 months follow-up
changes in dietary pattern
Time Frame: changes from baseline and 12 months follow-up
changes from baseline and 12 months follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in blood cholesterol level
Time Frame: changes from baseline and 12 months follow-up
changes from baseline and 12 months follow-up
changes in blood triglyceride level
Time Frame: changes from baseline and 12 months follow-up
changes from baseline and 12 months follow-up
Changes in body fat percentage
Time Frame: changes from baseline and 12 months follow-up
changes from baseline and 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

July 1, 2014

First Submitted That Met QC Criteria

July 1, 2014

First Posted (Estimate)

July 3, 2014

Study Record Updates

Last Update Posted (Estimate)

September 3, 2014

Last Update Submitted That Met QC Criteria

August 30, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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