Overweight and ObesityNCT02196012
A Technology-Based Intervention for the Reduction of Overweight and Obesity Among College Students
A study testing Intervention group in people with Overweight and Obesity, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jun 2014
- 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 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- Intervention group, attention control condition
- Keywords
- overweight, obesity, Technology, College Students
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
attention control conditionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | 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 Receives: Behavioral: Intervention group |
| attention control condition | Active comparator | 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. Receives: Behavioral: attention control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass index (BMI)
Measured: 2 months
Secondary outcomes (1)
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startSep 2013
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196012
- Sponsor's protocol ID
- 9271B
- Status last verified
- Jul 2014
- First submitted
- 28 Apr 2014
- Last updated
- 21 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The UTK Health Study" A Technology-Based Weight Loss Intervention for the Reduction of Overweight and Obesity Among College Students."
- ClinicalTrials.gov ID
- NCT02196012
- Acronym / sponsor ID
- 9271B
- Conditions
- Overweight and Obesity
- Keywords
- overweight, obesity, Technology, College Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Jul 2014 (estimated)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Intervention groupThe 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 |
| attention control condition | Active comparator | Behavioral: attention control conditionStudents 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. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Intervention group | Behavioural | Lifestyle counseling |
| attention control condition | Behavioural | attention control condition |
Primary outcome
body mass index (BMI)
Time frame: 2 months
1 secondary outcome
feasibility
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Overweight and Obesity, run by The University of Tennessee, Knoxville 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 21 Jul 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
body mass index (BMI) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2014.