## Protocol Section
### Identification Module
**NCT ID:** NCT01433679

**Brief Title:** The Effect of a Web-Based Behavioral Intervention on Physical Activity Levels in Adolescents

**Official Title:** The Effect of a Web-Based Behavioral Intervention on Physical Activity Levels in Adolescents

#### Organization Study ID Info
**ID:** HLZZ-001
#### Organization
**Class:** OTHER
**Full Name:** HopeLab Foundation
### Status Module
#### Completion Date
**Date:** 2012-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-07-16

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-07-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-07

**Type:** ACTUAL

#### Start Date
**Date:** 2011-09

**Status Verified Date:** 2012-07

#### Study First Post Date
**Date:** 2011-09-14
**Type:** ESTIMATED
**Study First Submit Date:** 2011-09-12
**Study First Submit QC Date:** 2011-09-12
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** West Virginia University

#### Lead Sponsor

**Class:** OTHER

**Name:** HopeLab Foundation

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed Description:** Physical activity is associated with a variety of positive health outcomes, as well as improved metabolic profiles and reduced inflammation. However, levels of moderate to vigorous physical activity (MVPA) diminish dramatically as children move into the middle school years. To address this problem, this study tests a behavioral intervention, called "Zamzee," designed to motivate middle school-aged children to increase their levels of MVPA. The Zamzee intervention consists of a 3-axis accelerometer that tracks individual physical activity rates over time and a website that displays individual physical activity rates and provides rewards for maintaining or improving physical activity rates. The primary aim of this randomized, controlled trial is to test whether middle school-aged children randomly assigned to the Zamzee intervention will show significantly greater levels of physical activity levels over six months, compared with control group participants who wear the accelerometer but have no access to the rewards website. A secondary aim is to test the intervention's impact on biological parameters that may contribute to the long-term health effects of inactivity (including C-reactive protein as a measure of inflammation, and hemoglobin-A1C as a measure of metabolic status) in a sub-set of study participants who agree to provide blood samples.

### Conditions Module

**Conditions:**

- Health Behavior

- Adolescent Behavior

- Motivation

**Keywords:**

- Health Behavior

- Exercise

- Adolescent Behavior

- Motivation

- Biological Markers

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 448

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: Zamzee Intervention

**Label:** Website intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Website intervention

**Description:** 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.

**Name:** Zamzee Intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Physical activity

**Time Frame:** Six months

#### Secondary Outcomes

**Description:** In the subset of study participants who agree to provide blood samples, blood samples collected at study baseline and at the six month study completion will be assayed for measures of inflammation (e.g., C-reactive protein) and metabolic function (e.g.,hemoglobin-A1C).

**Measure:** Metabolic and inflammatory biomarkers

**Time Frame:** Six months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Middle-school-aged students aged 11 to 14

Exclusion Criteria:

* 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

**Healthy Volunteers:** True

**Maximum Age:** 14 Years

**Minimum Age:** 11 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Los Osos

**Country:** United States

**Facility:** Los Osos Middle School

**State:** California

**Zip:** 93402

**Location 2:**

**City:** Oakland

**Country:** United States

**Facility:** Berkley Maynard Academy

**State:** California

**Zip:** 94605

**Location 3:**

**City:** Oakland

**Country:** United States

**Facility:** E.C. Reems Academy

**State:** California

**Zip:** 94605

**Location 4:**

**City:** Pismo Beach

**Country:** United States

**Facility:** Judkins Middle School

**State:** California

**Zip:** 93449

**Location 5:**

**City:** Vista

**Country:** United States

**Facility:** Vista Academy of Visual and Performing Arts

**State:** California

**Zip:** 92083

**Location 6:**

**City:** Morgantown

**Country:** United States

**Facility:** West Virginia University

**State:** West Virginia

**Zip:** 26506-6845

#### Overall Officials

**Official 1:**

**Affiliation:** HopeLab Foundation

**Name:** Jana Haritatos, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** HopeLab Foundation

**Name:** Steve Cole, PhD

**Role:** STUDY_DIRECTOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
