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Completed

NCT Number: NCT02496871

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.

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group Phone Calls

Behavioral

University of Kansas Weight Management Program - Group Phone calls

Other names: KWMP-GP

Social Media

Behavioral

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

Other names: KWMP-SM

Primary outcomes

  1. Change in weight

    Time frame: Change from Baseline to Month 6

Secondary outcomes

  1. Change in BMI

    Time frame: Change from Baseline to Month 6

  2. Physical activity - steps

    Time frame: Month 6

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

  3. Physical activity - total minutes

    Time frame: Month 6

    Average of total minutes per week of physical activity

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

    Time frame: 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

    Time frame: 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)

    Time frame: Change from Baseline to Month 6

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

  7. Quality of Life - Weight Related

    Time frame: Change from Baseline to Month 6

    Measured using the SHIELD-WQ-9 Questionnaire

  8. Feasibility of Interventions - adherence to protocol procedures

    Time frame: Month 6

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

Other outcomes

  1. Cost Analysis of Interventions

    Time frame: Month 6

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Blue Cross Blue Shield
  • Kansas City Area Life Sciences Institute, Inc.

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Jul 14, 2015
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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