Physical ActivityNCT03509129
Columbia Moves Physical Activity
A study testing TECH (Technology) and TECH+COMP (Technology + Competition) in people with Physical Activity, run by University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- TECH (Technology) and TECH+COMP (Technology + Competition)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2018to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: 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.
Read the 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).
- Conditions
- Physical Activity
- Being tested
- TECH (Technology), TECH+COMP (Technology + Competition)
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECH (Technology)Behavioural
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+COMP (Technology + Competition)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: TECH+COMP (Technology + Competition) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accelerometer-measured change from Baseline Daily Steps at 3 months and 12 months
Change in daily steps
Measured: 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
Change in moderate-to-vigorous physical activity
Measured: 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
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)
Measured: 0, 3, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start30 Apr 2018
- Primary completionJan 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Courtney Monroe, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509129
- Sponsor's protocol ID
- 2018
- Status last verified
- Apr 2018
- First submitted
- 16 Apr 2018
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will only be reported in aggregate.
Publications
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.
PubMed 37924083
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Columbia Moves: A Social Network Approach Using a Team Competition and Technology to Increase Physical Activity
- ClinicalTrials.gov ID
- NCT03509129
- Acronym / sponsor ID
- 2018
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 26 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TECH (Technology) | Active comparator | 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. |
| TECH+COMP (Technology + Competition) | Experimental | Behavioral: TECH+COMP (Technology + Competition)Participants will receive the same intervention components as the TECH goup, as well as a study designed team competition. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | TECH (Technology) |
| 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 | Behavioural | TECH+COMP (Technology + Competition) |
Primary outcome
Accelerometer-measured change from Baseline Daily Steps at 3 months and 12 months
Time frame: 0, 3, and 12 months
Change in daily steps
2 secondary outcomes
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 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Derived from this study: PubMed 37924083Monroe 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.
- Individual participant dataSharing planned: No. Data will only be reported in aggregate.
Related trials for Physical Activity
Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Huntington Disease, Sarcopenia
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Not yet recruitingPhase 1/2
A Study of SRN-101 Gene Therapy in Adults With Recurrent High-Grade Glioma (ALERT-1)
Recurrent High Grade Gliomas, Glioblastoma (GBM)
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney Monroe, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TECH (Technology) and TECH+COMP (Technology + Competition) in people with Physical Activity, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accelerometer-measured change from Baseline Daily Steps at 3 months and 12 months (time frame: 0, 3, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03509129, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2018.