NCT01625910

Brief Summary

Childhood obesity is a major public health problem in the U.S. Currently approximately one in three children is considered overweight or obese. Most overweight children grow to become overweight adults. It is unclear how effective pediatricians and other primary care physicians can be in assisting overweight children to normalize their body weight. Expert guidelines have been established, but are currently untested. This study will randomize overweight and obese children between the ages of 4 and 8 years old to either the recommended treatment guidelines or a control (non-intervention) group. The purpose of this study is to evaluate the ability (a) to recruit overweight children between the ages of 4 and 8 years old (b) to remeasure the children three months after enrollment and (c) to reduce childhood obesity via implementation of the recommended treatment guidelines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

2 active sites

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

September 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 22, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
10 months until next milestone

Results Posted

Study results publicly available

June 6, 2013

Completed
Last Updated

March 9, 2017

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

April 10, 2012

Results QC Date

April 9, 2013

Last Update Submit

January 26, 2017

Conditions

Obesity

Keywords

Childhood obesity treatmentMotivational interviewing

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index Z-score Change

    Change in body mass index z-score change over the three month time period

    Three months

Secondary Outcomes (1)

  • Sugar Sweetened Beverages

    Three months

Study Arms (2)

behavioral counseling

EXPERIMENTAL

Receive counseling via motivational interviewing seeking to encourage health eating habits and increased physical activity

Behavioral: Behavioral counseling

Instructions in school readiness and performance

PLACEBO COMPARATOR

Parents receive instructions in school readiness and performance

Behavioral: Behavioral counseling

Interventions

Behavioral counselingBEHAVIORAL

Counseling of parents to improve their child's diet and physical activity

Also known as: Motivational Interviewing, Pediatric obesity treatment
Instructions in school readiness and performancebehavioral counseling

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • any patient at the participating clinic between the ages of 4-8 years who have a BMI ≥ the 85th percentile

You may not qualify if:

  • emergent health concern
  • serious chronic health concern or recent gastrointestinal illness which may have resulted in weight loss
  • on medications known to affect weight

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fairview Children's Clinic

Minneapolis, Minnesota, 55414, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Behavior TherapyMotivational Interviewing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesDirective CounselingCounselingMental Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Limitations and Caveats

There were no adverse events during this 3-month trial comparing a parent-based behavioral intervention with usual care.

Results Point of Contact

Title
Steven D. Stovitz, MD, MS
Organization
University of Minnesota, Department of Family Medicine and Community Health
sstovitz@umphysicians.umn.edu
612-310-2344

Study Officials

  • Steven D Stovitz, MD, MS

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2012

First Posted

June 22, 2012

Study Start

September 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

March 9, 2017

Results First Posted

June 6, 2013

Record last verified: 2017-01

Locations

US(2)