A Technology-Based Intervention for the Reduction of Overweight and Obesity Among College Students

Overweight and Obesity Clinical Trial

Official title:

"The UTK Health Study" A Technology-Based Weight Loss Intervention for the Reduction of Overweight and Obesity Among College Students."

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196012
• Other study ID #: 9271B
• Status: Completed
• Phase: N/A
• First received: April 28, 2014
• Last updated: July 18, 2014
• Start date: September 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: The University of Tennessee Knoxville
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 22 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Intervention group

• attention control condition

Locations

Country	Name	City	State
United States	University of Tennessee	Knoxville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
The University of Tennessee Knoxville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	acceptability	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.	2 months	No
Primary	body mass index (BMI)		2 months	No
Secondary	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.	2 months	No