NCT02196012

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2014

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
Last Updated

July 21, 2014

Status Verified

July 1, 2014

Enrollment Period

8 months

First QC Date

April 28, 2014

Last Update Submit

July 18, 2014

Conditions

Overweight and Obesity

Keywords

overweightobesityTechnologyCollege Students

Outcome Measures

Primary Outcomes (1)

  • body mass index (BMI)

    2 months

Secondary Outcomes (1)

  • feasibility

    2 months

Other Outcomes (1)

  • acceptability

    2 months

Study Arms (2)

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

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.

Behavioral: attention control condition

Interventions

Intervention groupBEHAVIORAL
Lifestyle counseling
attention control conditionBEHAVIORAL
attention control condition

Eligibility Criteria

Age18 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2014

First Posted

July 21, 2014

Study Start

September 1, 2013

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

July 21, 2014

Record last verified: 2014-07

Locations

US(1)