Overview

This trial is active, not recruiting.

Condition obesity
Treatments group phone calls, social media
Sponsor University of Kansas Medical Center
Collaborator Blue Cross Blue Shield
Start date July 2015
End date June 2016
Trial size 70 participants
Trial identifier NCT02496871, STUDY00002758

Summary

The purpose of this study is to compare two different weight management delivery methods, social media versus a traditional care model.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Weekly group phone calls for 6 months. Group phone calls will last about 45 minutes each. Phone calls will include groups of 12-18 participants.
group phone calls KWMP-GP
University of Kansas Weight Management Program - Group Phone calls
(Experimental)
Participants interact through a private Facebook group. New activities for participants to complete each week for 6 months.
social media KWMP-SM
University of Kansas Weight Management Program - Social Media (Facebook)

Primary Outcomes

Measure
Change in weight
time frame: Change from Baseline to Month 6

Secondary Outcomes

Measure
Change in BMI
time frame: Change from Baseline to Month 6
Physical activity - steps
time frame: Month 6
Physical activity - total minutes
time frame: Month 6
Physical activity - ActiGraph Activity Level (Count/Minute; CPM)
time frame: 7 days
Dietary assessment - self-reported log
time frame: Month 6
Quality of Life Assessment (SF-36)
time frame: Change from Baseline to Month 6
Quality of Life - Weight Related
time frame: Change from Baseline to Month 6
Feasibility of Interventions - adherence to protocol procedures
time frame: Month 6

Eligibility Criteria

Male or female participants from 21 years up to 70 years old.

Inclusion Criteria: - Body mass index (BMI) of 30 to 45 kg/m^2 - Have access to a computer, smart phone, or tablet - Give informed consent to participate Exclusion Criteria: - Unable to participate in moderate intensity PA (i.e., walking) - Participation in a weight loss or physical activity program in the previous 6 mos. - Greater than 3, 30-min bouts of planned exercise/week - Not weight stable (±4.6 kg) for 3 mos. prior to intake - Unwilling to be randomized to 1 of the 2 study groups - Report being pregnant during the previous 6 mos., currently lactating, or planned pregnancy in the following 6 mos. - Serious medical risk such as cancer, recent cardiac event (i.e. heart attack, stroke, angioplasty) as determined by the individual's PCP via the clearance to participate in the investigation - Current use of antipsychotics or untreated depression - Adherence to specialized diet regimens, i.e., multiple food allergies, vegetarian, macrobiotic - Binge eating disorder as assessed by the Binge Eating Scale - Living in the same household as another study participant

Additional Information

Official title Remote Delivery of Weight Management by Phone and Social Media
Principal investigator Joseph Donnelly, PhD
Description Obesity is a major public health issue as 68% of the US population is either overweight or obese. Weight loss and weight loss maintenance is difficult. Traditionally, successful weight loss programs are weekly behaviorally-based clinics which utilize a combination of calorie restriction and physical activity. Traditional "face to face" weekly meetings may not be feasible for everyone. An alternative to provide weight loss and weight maintenance created by KUMC researchers uses weekly group phone conference calls. While this method produced equal weight loss with fewer burdens to participants when compared to the traditional "face to face" format, weight regain during maintenance was still high. This study will investigate a new delivery method (social media platform "Facebook") compared to the group phone conference calls. In the social media platform participants will be able to socialize with other participants in their group by commenting on posts from other participants or posting messages themselves. Social media delivered programs have potential to be a more a cost-effective approach to reach a large group of individuals. Participants who are eligible and decided to be in this study will take part in study related activities for 6 months.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Kansas Medical Center.