NCT02180802

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
408

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2014

Completed
Last Updated

September 3, 2014

Status Verified

August 1, 2014

Enrollment Period

2.2 years

First QC Date

July 1, 2014

Last Update Submit

August 30, 2014

Conditions

Obesity, Adolescent

Keywords

obese adolescentsBMI ≥ 95th percentile for age and gender

Outcome Measures

Primary Outcomes (6)

  • changes in BMI

    Body Mass Index

    changes from baseline and 12 months follow-up

  • Child Dietary Self-Efficacy

    Child Dietary Self-Efficacy Scale (CDSS)

    changes from baseline and 12 months follow-up

  • Weight Efficacy Lifestyle

    Weight Efficacy Lifestyle questionnaire (WEL)

    changes from baseline and 12 months follow-up

  • Physical Exercise Self-efficacy

    Physical Exercise Self-efficacy Scale (PES)

    changes from baseline and 12 months follow-up

  • 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 Outcomes (3)

  • 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

Study Arms (3)

motivational intervieing group

EXPERIMENTAL

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

motivational interviewi group with parental involvement

EXPERIMENTAL

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

Behavioral: motivational interviewing with parental involvement

Control

ACTIVE COMPARATOR

The patients received routine care

Behavioral: Control group

Interventions

motivational interviewingBEHAVIORAL
motivational intervieing group
motivational interviewing with parental involvementBEHAVIORAL
motivational interviewi group with parental involvement
Control groupBEHAVIORAL
Control

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • BMI equal or higher than 95th percentile for age and gender
  • years old

You may not qualify if:

  • medication with weight gain as side effects
  • diagnosed with having eating disorder
  • pregnant
  • clinical mental health conditions
  • psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient Pediatric Clinic

Qazvin, Qazvin Province, Iran

Location

MeSH Terms

Conditions

Pediatric ObesityCoitus

Interventions

Motivational InterviewingControl Groups

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice dean for research

Study Record Dates

First Submitted

July 1, 2014

First Posted

July 3, 2014

Study Start

February 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

September 3, 2014

Record last verified: 2014-08

Locations

IR(1)