Clinical trial NCT02496871: Remote Delivery of Weight Management by Phone and Social Media
Official title: Remote Delivery of Weight Management by Phone and Social Media
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield
name: Kansas City Area Life Sciences Institute, Inc.
First posted: 2015-07-14
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in weight
timeFrame: Change from Baseline to Month 6
Secondary outcomes:
measure: Change in BMI
timeFrame: Change from Baseline to Month 6
measure: Physical activity - steps
timeFrame: Month 6
measure: Physical activity - total minutes
timeFrame: Month 6
measure: Physical activity - ActiGraph Activity Level (Count/Minute; CPM)
timeFrame: 7 days
measure: Dietary assessment - self-reported log
timeFrame: Month 6
measure: Quality of Life Assessment (SF-36)
timeFrame: Change from Baseline to Month 6
measure: Quality of Life - Weight Related
timeFrame: Change from Baseline to Month 6
measure: Feasibility of Interventions - adherence to protocol procedures
timeFrame: Month 6
Other outcomes:
measure: Cost Analysis of Interventions
timeFrame: Month 6
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Joseph Donnelly, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Willis EA, Szabo-Reed AN, Ptomey LT, Steger FL, Honas JJ, Al-Hihi EM, Lee R, Vansaghi L, Washburn RA, Donnelly JE. Distance learning strategies for weight management utilizing social media: A comparison of phone conference call versus social media platform. Rationale and design for a randomized study. Contemp Clin Trials. 2016 Mar;47:282-8. doi: 10.1016/j.cct.2016.02.005. Epub 2016 Feb 12.