NCT03509129

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

April 30, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

November 28, 2018

Status Verified

April 1, 2018

Enrollment Period

8 months

First QC Date

April 16, 2018

Last Update Submit

November 27, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Accelerometer-measured change from Baseline Daily Steps at 3 months and 12 months

    Change in daily steps

    0, 3, and 12 months

Secondary Outcomes (2)

  • Accelerometer-measured change from Baseline Minutes of Moderate-to-Vigorous Physical Activity at 3 months and 12 months

    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

    0, 3, and 12 months

Other Outcomes (1)

  • Participant Satisfaction (Satisfaction Questionnaire)

    4 months

Study Arms (2)

TECH (Technology)

ACTIVE COMPARATOR

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)

TECH+COMP (Technology + Competition)

EXPERIMENTAL

Participants will receive the same intervention components as the TECH goup, as well as a study designed team competition.

Behavioral: TECH+COMP (Technology + Competition)

Interventions

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

TECH (Technology)

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

TECH+COMP (Technology + Competition)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (1)

  • Monroe CM, Cai B, Edney S, Jake-Schoffman DE, Brazendale K, Bucko A, Armstrong B, Yang CH, Turner-McGrievy G. Harnessing technology and gamification to increase adult physical activity: a cluster randomized controlled trial of the Columbia Moves pilot. Int J Behav Nutr Phys Act. 2023 Nov 3;20(1):129. doi: 10.1186/s12966-023-01530-1.

MeSH Terms

Conditions

Motor Activity

Interventions

PLEKHG5 protein, humanTechnology

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture

Study Officials

  • Courtney Monroe, PhD

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2018

First Posted

April 26, 2018

Study Start

April 30, 2018

Primary Completion

January 1, 2019

Study Completion

May 1, 2019

Last Updated

November 28, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Data will only be reported in aggregate.

Locations