Gaming Technology to Encourage Healthy Weight and Activity in Youth

NCT02560493 | Completed Results

• 1 other identifier: PBRC 2015-037
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the proposed randomized controlled trial is to test the efficacy of exergaming (i.e. video gaming that involves physical activity) to reduce adiposity in overweight and obese children.

Conditions

Childhood Obesity

Keywords

BMIz; Exergaming; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Changes in Body Mass Index Z-score (BMIz) Compared to a Control Group

  Height and weight will be collected at Screening, Week 0, and Week 24. Standing height will be measured in cm with a Harpenden stadiometer (Holtain Limited, Crymych, UK) with shoes removed while the participant holds breath and an assessor applies light traction to align the participant's head along the Frankfort Horizontal Plane. Weight will be measured in kg with a Michelli GSE 460 scale (G.T. Michelli Co., Baton Rouge, LA) while wearing a hospital gown and undergarments. Measures will be taken twice and recorded to the nearest 0.1 units, with a third if the initial 2 measures are greater than 0.5 units apart. BMIz will be calculated based on the child's age, sex, height, and weight using the 2000 Centers for Disease Control and Prevention (CDC) Growth Charts. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean

  Change between Baseline (Week 0) and 6 months (Week 24)

Secondary Outcomes (7)

• Changes in Body Fat

  Change between Baseline (Week 0) and 6 months (Week 24)

• Changes in Systolic Blood Pressure

  Change between Baseline (Week 0) and 6 months (Week 24)

• Changes in Diastolic Blood Pressure

  Change between Baseline (Week 0) and 6 months (Week 24)

• Changes in Total Cholesterol

  Change between Baseline (Week 0) and 6 months (Week 24)

• Changes in Fasting Glucose

  Change between Baseline (Week 0) and 6 months (Week 24)

Study Arms (2)

Control Condition

NO INTERVENTION

Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.

Exergaming Condition

EXPERIMENTAL

Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.

Behavioral: Exergaming Condition

Interventions

Exergaming Condition BEHAVIORAL

Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.

Exergaming Condition

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• BMI percentile \> or equal to 85 on the CDC growth chart
• Participating household has a high-speed internet connection
• At least 1 family member or friend who is willing to exergame in the home with the participant for 3 hours/week

You may not qualify if:

• Pregnant
• Impairments that prevent normal ambulation
• Previous history, or current symptoms of, cardiovascular disease, musculoskeletal injury, or epileptic seizures

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• American Heart Association: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

• Staiano AE, Beyl RA, Guan W, Hendrick CA, Hsia DS, Newton RL Jr. Home-based exergaming among children with overweight and obesity: a randomized clinical trial. Pediatr Obes. 2018 Nov;13(11):724-733. doi: 10.1111/ijpo.12438. Epub 2018 Jul 20.

  PMID: 30027607 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Amanda Staiano
• Organization: LSU's Pennington Biomedical Research Center

amanda.staiano@pbrc.edu

2257632869

Study Officials

• Amanda E Staiano, PhD

  Pennington Biomedical Research Center

  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: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: September 25, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 29, 2024
• Results First Posted: August 19, 2019

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)