Back to resultsA Technology-Based Intervention for the Reduction of Overweight and Obesity Among College Students
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention group
attention control condition
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity focused on measuring overweight, obesity, Technology, College Students
Eligibility Criteria
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.
Sites / Locations
- University of Tennessee
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lifestyle counseling
attention control condition
Arm Description
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
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.
Outcomes
Primary Outcome Measures
body mass index (BMI)
Secondary Outcome Measures
feasibility
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.
Full Information
NCT ID
NCT02196012
First Posted
April 28, 2014
Last Updated
July 18, 2014
Sponsor
The University of Tennessee, Knoxville
1. Study Identification
Unique Protocol Identification Number
NCT02196012
Brief Title
A Technology-Based Intervention for the Reduction of Overweight and Obesity Among College Students
Official Title
"The UTK Health Study" A Technology-Based Weight Loss Intervention for the Reduction of Overweight and Obesity Among College Students."
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Tennessee, Knoxville
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
overweight, obesity, Technology, College Students
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
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
Arm Title
attention control condition
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention group
Intervention Type
Behavioral
Intervention Name(s)
attention control condition
Primary Outcome Measure Information:
Title
body mass index (BMI)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
feasibility
Description
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.
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
acceptability
Description
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.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37996
Country
United States
12. IPD Sharing Statement
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A Technology-Based Intervention for the Reduction of Overweight and Obesity Among College Students
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