NCT02496871

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable obesity

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

First Submitted

Initial submission to the registry

June 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

4.5 years

First QC Date

June 30, 2015

Last Update Submit

March 23, 2020

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in weight

    Change from Baseline to Month 6

Secondary Outcomes (8)

  • Change in BMI

    Change from Baseline to Month 6

  • Physical activity - steps

    Month 6

  • Physical activity - total minutes

    Month 6

  • Physical activity - ActiGraph Activity Level (Count/Minute; CPM)

    7 days

  • Dietary assessment - self-reported log

    Month 6

  • +3 more secondary outcomes

Other Outcomes (1)

  • Cost Analysis of Interventions

    Month 6

Study Arms (2)

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

Group Phone CallsBEHAVIORAL

University of Kansas Weight Management Program - Group Phone calls

Also known as: KWMP-GP
KWMP-GP
Social MediaBEHAVIORAL

University of Kansas Weight Management Program - Social Media (Facebook)

Also known as: KWMP-SM
KWMP-SM

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

  • 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.

    PMID: 26883282DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Media Exposure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

SociologySocial SciencesBehavioral SciencesBehavioral Disciplines and Activities

Study Officials

  • Joseph Donnelly, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 30, 2015

First Posted

July 14, 2015

Study Start

July 1, 2015

Primary Completion

December 30, 2019

Study Completion

February 25, 2020

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

US(1)