NCT02436330

Brief Summary

Evaluation of the effectiveness of Exergaming for Health, a community-based multifaceted weight management program in a randomized controlled trial (RCT). Primary objective: to assess impact of the program on BMI z-scores. Secondary objectives: to measure impact on cardiovascular fitness, self-worth, sedentary screen time, and the influence of exergaming component on attendance and participation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

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

March 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
7 months until next milestone

Results Posted

Study results publicly available

December 14, 2015

Completed
Last Updated

December 14, 2015

Status Verified

November 1, 2015

Enrollment Period

2.5 years

First QC Date

April 20, 2015

Results QC Date

May 28, 2015

Last Update Submit

November 5, 2015

Conditions

Keywords

Exergaming, Weight management

Outcome Measures

Primary Outcomes (2)

  • BMI Z-score Change

    All subjects were asked to dress in light athletic clothing and have their weight and height measured at baseline (the first group session) and at 6 months. Research assistants were trained using guidelines from the National Health and Nutrition Examination Survey (NHANES) Anthropometry Procedures Manual and demonstrated accurate measures on 3 separate children. The Seca 217 portable stadiometer was used for all height measurements and the HealthOMeter 844 KL scale was used for all weight measurements. BMI z-scores were calculated using software available from the Children's Hospital of Philadelphia Research Institute (http://stokes.chop.edu/web/zcore).

    Change from baseline at 6 months

  • BMI Z-score Change

    Measure was only taken on the subjects who participated in the Intervention group (exergaming combined with didactic teaching).

    Change from baseline BMI z-score at 1 year

Secondary Outcomes (20)

  • Waist Circumference Change

    Change from baseline at 6 months

  • Systolic Blood Pressure Change

    Change from baseline Systolic BP at 6 months

  • Heart Rate Change From Baseline to 6 Months

    Change from baseline at 6 months

  • Shuttle Run Change in Number of Shuttle Runs

    Change in number from baseline shuttle run at 6 months

  • After School Screen Time as Reported on Questionnaire

    Change from baseline at 6 months

  • +15 more secondary outcomes

Study Arms (2)

Exergaming and Didactic health teaching

EXPERIMENTAL

Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.

Behavioral: ExergamingBehavioral: Didactic health teaching

Didactic health teaching

ACTIVE COMPARATOR

Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.

Behavioral: Didactic health teaching

Interventions

ExergamingBEHAVIORAL

6 months of weight management programming consisting of 10 weekly sessions:1 hour of session was spent "exergaming", which included active video game play and traditional group exercises. Some examples include: Dance, Dance, Revolution, Exerbike, Treadwall, Yoga, Spin class, etc.

Exergaming and Didactic health teaching

6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1 hour didactic health teaching sessions for the remainder of the 6 month period.

Didactic health teachingExergaming and Didactic health teaching

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Child with BMI greater than or equal to 85th percentile.
  • English speaking
  • Approval by Primary Care Doctor

You may not qualify if:

  • Participants with medical, developmental or psychiatric diagnoses which preclude participation in both the physical activity and classroom portions of the curriculum.
  • Participants who are taking medications that positively or negatively affect weight.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (50)

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MeSH Terms

Conditions

Pediatric Obesity

Interventions

Exergaming

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Limitations: incomplete data collection (baseline \& follow-up), those lost to follow-up may have been unwilling to continue because of weight gain, low enrollment numbers, and control subjects were offered intervention activities after 6 months.

Results Point of Contact

Title
Dr. Amy L. Christison
Organization
University of Illinois College of Medicine at Peoria

Study Officials

  • Amy L. Christison, MD

    University of Illinois College of Medicine at Peoria

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

April 20, 2015

First Posted

May 6, 2015

Study Start

March 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

December 14, 2015

Results First Posted

December 14, 2015

Record last verified: 2015-11