Columbia Moves Physical Activity

November 27, 2018 updated by: University of South Carolina

Evaluating Columbia Moves: A Social Network Approach Using a Team Competition and Technology to Increase Physical Activity

The purpose of this study is to evaluate the effect of adding a team competition comprised of members of existing social networks to a technology-delivered program for enhancing physical activity among insufficiently active adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This 3-month randomized controlled trial is designed to investigate the efficacy and feasibility of a novel, technology-oriented physical activity intervention characterized by existing social networks and a team competition. Participants will be recruited via emails, fliers, and word of mouth. They will be randomized to a technology-mediated physical activity treatment (TECH) or a treatment which receives an identical intervention as TECH plus a study designed team competition for physical activity promotion (TECH+COMP).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
116

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Insufficiently active as determined by a one-week, accelerometer-based physical activity measurement
  • Body mass index (BMI) between 25 kg/m2 and 55 kg/m2
  • Between ages 18 and 65 years
  • Access to computer with Internet connection
  • Smartphone ownership (Android or iOS)
  • Willing to be randomized to either one of the two study groups
  • Part of a self-selected team of 3-8 eligible individuals
  • Members of the same household cannot be part of separate groups
  • Able to walk at least 1/4 mile without stopping

Exclusion Criteria:

  • Currently lactating, pregnant, or planning to become pregnant during the length of the study
  • Diagnosed with type 1 or type 2 diabetes
  • Medical or physical contraindications or limitations for engaging in physical activity
  • History of major medical or psychiatric conditions
  • Currently participating in a physical activity program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: TECH (Technology)
Participants will receive a theory-based physical activity program. They will enroll in the study as part of a self-selected group of 3-8 individuals. They will be provided with a personal step goal and Fitbit Alta HR for self-monitoring physical activity. They will also have access to a study website that will be accessible across conventional and mobile platforms. They will be asked to visit the website each week to receive behavior change information and guidance.
Behavioral: TECH (Technology)

Participants will receive a theory-based physical activity program. They will enroll in the study as part of a self-selected group of 3-8 individuals. They will be provided with a personal step goal and Fitbit Alta HR for self-monitoring physical activity. They will also have access to a study website that will be accessible across conventional and mobile platforms. They will be asked to visit the website each week to receive behavior change information and guidance.

Device: Fitbit Alta HR
Experimental: TECH+COMP (Technology + Competition)
Participants will receive the same intervention components as the TECH goup, as well as a study designed team competition.
Behavioral: TECH+COMP (Technology + Competition)

Participants will receive the same intervention components as the TECH group, as well as a team competition. The competition will be based on the following two aspects: total daily steps accumulated relative to group size and total number of points retained for achieving weekly physical activity challenges.

Device: Fitbit Alta HR

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Accelerometer-measured change from Baseline Daily Steps at 3 months and 12 months
Time Frame: 0, 3, and 12 months
Change in daily steps
0, 3, and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Accelerometer-measured change from Baseline Minutes of Moderate-to-Vigorous Physical Activity at 3 months and 12 months
Time Frame: 0, 3, and 12 months
Change in moderate-to-vigorous physical activity
0, 3, and 12 months
Change from Baseline in Perceived Social Support for Exercise (Sallis Social Support and Exercise Survey) at 3 and 12 months
Time Frame: 0, 3, and 12 months
Change in perceived social support for exercise (scale total score range: 1 to 5, with 1 representing low perceived social support for exercise and 5 representing high perceived social support for exercise; responses to all items are averaged to yield a total final score)
0, 3, and 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant Satisfaction (Satisfaction Questionnaire)
Time Frame: 4 months
Participant satisfaction with treatment
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will only be reported in aggregate.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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