Columbia Moves Physical Activity

Sponsor

University of South Carolina (Other)

Overall Status

Unknown status

CT.gov ID

NCT03509129

Collaborator

(none)

116

Enrollment

Location

Arms

Anticipated Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Physical Activity	Behavioral: TECH (Technology) Behavioral: TECH+COMP (Technology + Competition)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 30, 2018

Anticipated Primary Completion Date :

Jan 1, 2019

Anticipated Study Completion Date :

May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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)

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

Outcome Measures

Primary Outcome Measures

Accelerometer-measured change from Baseline Daily Steps at 3 months and 12 months [0, 3, and 12 months]
Change in daily steps

Secondary Outcome Measures

Accelerometer-measured change from Baseline Minutes of Moderate-to-Vigorous Physical Activity at 3 months and 12 months [0, 3, and 12 months]
Change in moderate-to-vigorous physical activity
Change from Baseline in Perceived Social Support for Exercise (Sallis Social Support and Exercise Survey) at 3 and 12 months [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)

Other Outcome Measures

Participant Satisfaction (Satisfaction Questionnaire) [4 months]
Participant satisfaction with treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Carolina	Columbia	South Carolina	United States	29208

Sponsors and Collaborators

University of South Carolina

Investigators

Principal Investigator: Courtney Monroe, PhD, University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of South Carolina

ClinicalTrials.gov Identifier:

NCT03509129

Other Study ID Numbers:

2018

First Posted:

Apr 26, 2018

Last Update Posted:

Nov 28, 2018

Last Verified:

Apr 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 28, 2018