- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02196012
A Technology-Based Intervention for the Reduction of Overweight and Obesity Among College Students
July 18, 2014 updated by: The University of Tennessee, Knoxville
"The UTK Health Study" A Technology-Based Weight Loss Intervention for the Reduction of Overweight and Obesity Among College Students."
The purpose of this study is to determine the feasibility and acceptability and efficacy of a two month technology-based weight loss program for overweight and obese college students.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A randomized controlled trial design will be employed to investigate the effectiveness, feasibility, and acceptability of a technology-based weight loss pilot intervention for the reduction of overweight and obesity in college students.
Participants will be randomly assigned to one of two conditions: (1) 8-week intervention group, or (2) 8-week attention control group.
Both conditions include 8 weekly lessons over 8 weeks.
Undergraduate students (n=100) age 18-22 years who are overweight or obese (BMI ≥ 25 kg/m2) will be recruited from the University of Tennessee Knoxville.
Measurements will be taken at baseline and 8 weeks.
Since the study is a technology-based intervention, research staff will collect height and weight measures for BMI through a novel approach, utilizing Skype video conferencing.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- 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
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Tennessee
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Knoxville, Tennessee, United States, 37996
- University of Tennessee
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-
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
Ages Eligible for Study
18 years to 22 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Eligibility will include UTK undergraduate students who are overweight or obese (BMI ≥ 25 kg/m2) and between 18-22 years of age, with access to the Internet, a personal computer (laptop, tablet, or desktop computer), and a smartphone.
Exclusion Criteria:
- Any individual who does not meet all the inclusion criteria will be excluded from participation in the study.
- Students who have a medical condition that precludes adherence to dietary recommendations
- Who are currently prescribed medications that may impact weight, or who are currently participating in or planning to participate in another weight loss programs in the next six months
- Who have been diagnosed with a major psychiatric illness (e.g., bipolar disorder, schizophrenia, or depression) within the last 12 months
- Who are pregnant or plan to become pregnant in the next six months
- Who have given birth within the last six months
- Who have been diagnosed with any type of eating disorder within the past 12 months will be ineligible.
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Lifestyle counseling
The intervention condition will contain multiple components: nutrition education, physical activity, social support, social media (Pinterest and Facebook), and smartphone applications for self-monitoring.
Students in this condition will have access to the private study website, which will be the central platform for delivery of the program materials and social support.
The website, developed using Wordpress.com,
will include nutrition materials, exercise videos, a forum, and links to the study's Facebook and Pinterest pages
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|
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Active Comparator: attention control condition
Students randomized to the attention control condition will receive educational emails three times per week.
Nutrition materials will be sent once a week, and links to the YouTube exercise videos will be sent twice a week.
At the start of the program, students will be emailed a link to the Pandora workout station.
The materials sent to the control group will be the same materials posted on the website for the intervention group.
Participants will access the emailed lessons and videos each week at their own convenience.
Individuals in the attention control condition will not have access to the study website or social media pages.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
body mass index (BMI)
Time Frame: 2 months
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
feasibility
Time Frame: 2 months
|
A mixed methods approach, including online surveys and focus groups, was employed to assess the feasibility of the pilot study.
Feasibility was assessed through recruitment and retention data and self-reported records of participant engagement.
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2 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
acceptability
Time Frame: 2 months
|
Participants in both groups completed an online post-intervention survey.
Data were collected and compiled through SurveyMonkey.
Surveys were comprised of a combination of closed-ended and open-ended questions.
Participants completed text-based focus group using Skype group messaging.
Participants were asked to provide feedback on each technology tool in the program, the website, methods of delivery, the duration of the program, and the overall program.
A benefit was that the online tools allowed students to maintain anonymity, which could have encouraged participation and sharing.
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2 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
September 1, 2013
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
April 28, 2014
First Submitted That Met QC Criteria
July 18, 2014
First Posted (Estimate)
July 21, 2014
Study Record Updates
Last Update Posted (Estimate)
July 21, 2014
Last Update Submitted That Met QC Criteria
July 18, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9271B
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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