NCT01433679

Brief Summary

The primary purpose of this study is to test whether rewarding physical activity with a motivational website will increase physical activity levels in middle school-aged children over six months. As a secondary outcome, the study also tests the intervention's impact on biological measures of inflammation and metabolic function in a sub-set of study participants who agree to provide blood samples.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
448

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

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
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 16, 2012

Status Verified

July 1, 2012

Enrollment Period

10 months

First QC Date

September 12, 2011

Last Update Submit

July 12, 2012

Conditions

Keywords

Health BehaviorExerciseAdolescent BehaviorMotivationBiological Markers

Outcome Measures

Primary Outcomes (1)

  • Physical activity

    The amount and intensity of physical activity is recorded continuously every study day that participants wear their accelerometer for the duration of the six month study. The primary outcome reported will be rates of "moderate to vigorous physical activity" as defined by the CDC.

    Six months

Secondary Outcomes (1)

  • Metabolic and inflammatory biomarkers

    Six months

Study Arms (2)

Website intervention

EXPERIMENTAL

Participants randomly assigned to the Website Intervention arm receive access to the motivational rewards website. The website displays the individual's physical activity data and allocates reward points based on the amount and intensity of physical activity. The website also allows reward points to be redeemed for various rewards such as gift cards to retail outlets, donations to charities, small tangible goods, and customization of participants' cartoon-like avatars on the website.

Behavioral: Zamzee Intervention

Control

NO INTERVENTION

Participants in the control group will not have access to the motivational website. No other product or intervention will be introduced to the control group.

Interventions

The Zamzee intervention is designed to motivate middle school-aged children to increase their rates of moderate to vigorous physical activity (MVPA) by providing rewards based on amount and duration of physical activity. Rewards include gift cards to retail stores, donations to charity, small tangible goods, and customization of their cartoon-like avatars on the website.

Website intervention

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Middle-school-aged students aged 11 to 14

You may not qualify if:

  • Previously participation in a Zamzee pilot study
  • Existing medical conditions or health complications that will interfere with the ability to be physically active
  • Inability to read and write English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Los Osos Middle School

Los Osos, California, 93402, United States

Location

Berkley Maynard Academy

Oakland, California, 94605, United States

Location

E.C. Reems Academy

Oakland, California, 94605, United States

Location

Judkins Middle School

Pismo Beach, California, 93449, United States

Location

Vista Academy of Visual and Performing Arts

Vista, California, 92083, United States

Location

West Virginia University

Morgantown, West Virginia, 26506-6845, United States

Location

MeSH Terms

Conditions

Health BehaviorAdolescent BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jana Haritatos, PhD

    HopeLab Foundation

    PRINCIPAL INVESTIGATOR
  • Steve Cole, PhD

    HopeLab Foundation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2011

First Posted

September 14, 2011

Study Start

September 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 16, 2012

Record last verified: 2012-07

Locations