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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03509129
Other study ID # 2018
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 30, 2018
Est. completion date May 2019

Study information

Verified date April 2018
Source University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 116
Est. completion date May 2019
Est. primary completion date January 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
United States University of South Carolina Columbia South Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Participant Satisfaction (Satisfaction Questionnaire) Participant satisfaction with treatment 4 months
Primary Accelerometer-measured change from Baseline Daily Steps at 3 months and 12 months Change in daily steps 0, 3, and 12 months
Secondary 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 0, 3, and 12 months
Secondary 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) 0, 3, and 12 months
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