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

Sponsor

Qazvin University Of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT02180802

Collaborator

(none)

408

Enrollment

Location

Arms

Duration (Months)

15.7

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Obesity, Adolescent	Behavioral: motivational interviewing Behavioral: motivational interviewing with parental involvement Behavioral: Control group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

408 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

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	Behavioral: motivational interviewing
Experimental: motivational interviewi group with parental involvement an additional single session with parents or guardians over 60 minutes in the clinic	Behavioral: motivational interviewing with parental involvement
Active Comparator: Control The patients received routine care	Behavioral: Control 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

Behavioral: motivational interviewing

Experimental: motivational interviewi group with parental involvement

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

Behavioral: motivational interviewing with parental involvement

Active Comparator: Control

The patients received routine care

Behavioral: Control group

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in blood cholesterol level [changes from baseline and 12 months follow-up]
changes in blood triglyceride level [changes from baseline and 12 months follow-up]
Changes in body fat percentage [changes from baseline and 12 months follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Outpatient Pediatric Clinic	Qazvin		Iran, Islamic Republic of

Sponsors and Collaborators

Qazvin University Of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amir H Pakpour, vice dean for research, Qazvin University Of Medical Sciences

ClinicalTrials.gov Identifier:

NCT02180802

Other Study ID Numbers:

3287

First Posted:

Jul 3, 2014

Last Update Posted:

Sep 3, 2014

Last Verified:

Aug 1, 2014

Keywords provided by Amir H Pakpour, vice dean for research, Qazvin University Of Medical Sciences

obese adolescents

BMI ≥ 95th percentile for age and gender

Additional relevant MeSH terms:

Pediatric Obesity

Study Results

No Results Posted as of Sep 3, 2014