NCT02086851

Brief Summary

The study will enroll 110 overweight and obese adolescents ages 11-16 in a lifestyle modification program focusing on dietary modification and exercise. Parents will be randomized into control and motivational interviewing-based intervention groups. The primary hypothesis is that adolescents whose parents are in the intervention group will have improved compliance, weight loss and health outcomes compared with adolescents whose parents do not receive the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 11, 2016

Status Verified

February 1, 2016

Enrollment Period

3.9 years

First QC Date

February 7, 2014

Last Update Submit

February 10, 2016

Conditions

Pediatric ObesityImpact of Parent Intervention on Adolescent Weight Loss

Keywords

pediatric obesitymotivational interviewinglifestyle intervention

Outcome Measures

Primary Outcomes (1)

  • Change in BMI z-scores

    12 weeks, 6 months and 12 months

Secondary Outcomes (11)

  • Changes in body composition

    12 weeks, 6 months and 1 year

  • Changes in BMI

    12 weeks, 6 months and 12 months

  • Changes in insulin sensitivity

    12 weeks, 6 months and 12 months

  • Changes in blood pressure

    12 weeks, 6 months and 12 months

  • Changes in serum lipids

    12 weeks, 6 months and 12 months

  • +6 more secondary outcomes

Study Arms (2)

Lifestyle Intervention plus Parent Motivational Interviewing

EXPERIMENTAL

Lifestyle intervention + Parent MI

Behavioral: Lifestyle InterventionBehavioral: Parent Motivational Interviewing

Lifestyle Intervention alone

ACTIVE COMPARATOR

lifestyle intervention alone

Behavioral: Lifestyle Intervention

Interventions

Lifestyle InterventionBEHAVIORAL
Lifestyle Intervention aloneLifestyle Intervention plus Parent Motivational Interviewing
Parent Motivational InterviewingBEHAVIORAL
Lifestyle Intervention plus Parent Motivational Interviewing

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHoR at VCU Healthy Lifestyles Center

Henrico, Virginia, 23229, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Edmond P Wickham, MD, MPH

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2014

First Posted

March 13, 2014

Study Start

September 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

February 11, 2016

Record last verified: 2016-02

Locations

US(1)