Remote Delivery of Weight Management by Phone and Social Media

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Group Phone Calls; Behavioral: Social Media

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: KWMP-GP; 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.	Behavioral: Group Phone Calls; University of Kansas Weight Management Program - Group Phone calls; Other Names: KWMP-GP
Experimental: KWMP-SM; Participants interact through a private Facebook group. New activities for participants to complete each week for 6 months.	Behavioral: Social Media; University of Kansas Weight Management Program - Social Media (Facebook); Other Names: KWMP-SM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in weight	Change from Baseline to Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BMI		Change from Baseline to Month 6
Physical activity - steps	Measured using pedometer to report steps per day on a weekly basis	Month 6
Physical activity - total minutes	Average of total minutes per week of physical activity	Month 6
Physical activity - ActiGraph Activity Level (Count/Minute; CPM)	Average ActiGraph counts/minute over 7-day period. Activity level based on cut points used in NHANES as described by Troiano. Cut points used will be Sedentary: 0 - 99 CPM; Light: 100 - 2019 CPM; Moderate: 2020 - 5998 CPM; Vigorous: 5999 - ∞ CPM.	7 days
Dietary assessment - self-reported log	Participants will complete dietary intake log, including 2 weekdays and 1 weekend day, using MyFitnessPal application prior to baseline and month 6 visits.	Month 6
Quality of Life Assessment (SF-36)	Measured using the Short Form 36 (SF-12) Health Survey.	Change from Baseline to Month 6
Quality of Life - Weight Related	Measured using the SHIELD-WQ-9 Questionnaire	Change from Baseline to Month 6
Feasibility of Interventions - adherence to protocol procedures	Participants adherence to diet, physical activity and attendance/participation in weight loss sessions.	Month 6

Other Outcome Measures

Outcome Measure	Time Frame
Cost Analysis of Interventions	Month 6

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: Blue Cross Blue Shield; Kansas City Area Life Sciences Institute, Inc.
• Investigators: Principal Investigator: Joseph Donnelly, PhD, University of Kansas Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): February 25, 2020

Study Registration Dates

• First Submitted: June 30, 2015
• First Submitted That Met QC Criteria: July 9, 2015
• First Posted (Estimate): July 14, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00002758

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No