Remote Delivery of Weight Management by Phone and Social Media

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

Detailed Description
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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.

Official Title
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Remote Delivery of Weight Management by Phone and Social Media

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Group Phone Calls
* Behavioral: Social Media


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |