Remote Delivery of Weight Management by Phone and Social... | NCT02496871

Studies
Remote Delivery of Weight Management by Phone and Social Media

NCT02496871

Sponsor

University of Kansas Medical Center

Status

Completed

Last Update Posted

Mar 25, 2020Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Obesity

Interventions

Group Phone Calls
Social Media

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015Actual

Primary Completion Date

Dec 30, 2019Actual

Completion Date

Feb 25, 2020Actual

First Submitted Date

Jun 30, 2015

First Submission Date that Met QC Criteria

Jul 9, 2015

First Posted Date

Jul 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2020

Last Update Posted Date

Mar 25, 2020Actual

Name	Class
Blue Cross Blue Shield	OTHER
Kansas City Area Life Sciences Institute, Inc.	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KWMP-GP	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.	Behavioral: Group Phone Calls
KWMP-SM	Experimental	Participants interact through a private Facebook group. New activities for participants to complete each week for 6 months.	Behavioral: Social Media

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Group Phone Calls	Behavioral	University of Kansas Weight Management Program - Group Phone calls	KWMP-GP

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Cost Analysis of Interventions		Month 6

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph Donnelly, PhD	University of Kansas Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kansas Medical Center		Kansas City	Kansas	66160	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26883282	Derived	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.

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D012961	Sociology
D012942	Social Sciences
D001525	Behavioral Sciences
D004191	Behavioral Disciplines and Activities