Remote Delivery of Weight Management by Phone and Social Media

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02496871
Collaborator
Blue Cross Blue Shield (Other), Kansas City Area Life Sciences Institute, Inc. (Other)
70
1
2
55.9
1.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Group Phone Calls
  • Behavioral: Social Media
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Remote Delivery of Weight Management by Phone and Social Media
Actual Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Dec 30, 2019
Actual Study Completion Date :
Feb 25, 2020

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Change in weight [Change from Baseline to Month 6]

    Secondary Outcome Measures

    1. Change in BMI [Change from Baseline to Month 6]

    2. Physical activity - steps [Month 6]

      Measured using pedometer to report steps per day on a weekly basis

    3. Physical activity - total minutes [Month 6]

      Average of total minutes per week of physical activity

    4. Physical activity - ActiGraph Activity Level (Count/Minute; CPM) [7 days]

      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.

    5. Dietary assessment - self-reported log [Month 6]

      Participants will complete dietary intake log, including 2 weekdays and 1 weekend day, using MyFitnessPal application prior to baseline and month 6 visits.

    6. Quality of Life Assessment (SF-36) [Change from Baseline to Month 6]

      Measured using the Short Form 36 (SF-12) Health Survey.

    7. Quality of Life - Weight Related [Change from Baseline to Month 6]

      Measured using the SHIELD-WQ-9 Questionnaire

    8. Feasibility of Interventions - adherence to protocol procedures [Month 6]

      Participants adherence to diet, physical activity and attendance/participation in weight loss sessions.

    Other Outcome Measures

    1. Cost Analysis of Interventions [Month 6]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kansas Medical Center Kansas City Kansas United States 66160

    Sponsors and Collaborators

    • University of Kansas Medical Center
    • Blue Cross Blue Shield
    • Kansas City Area Life Sciences Institute, Inc.

    Investigators

    • Principal Investigator: Joseph Donnelly, PhD, University of Kansas Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Joseph Donnelly, Professor, University of Kansas
    ClinicalTrials.gov Identifier:
    NCT02496871
    Other Study ID Numbers:
    • STUDY00002758
    First Posted:
    Jul 14, 2015
    Last Update Posted:
    Mar 25, 2020
    Last Verified:
    Mar 1, 2020

    Study Results

    No Results Posted as of Mar 25, 2020