- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02344836
The Social Pounds Off Digitally (Social POD) Study (SocialPOD)
Refining and Pilot Testing Social Networks for Encouraging Healthy Behaviors: The Social Pounds Off Digitally (Social POD) Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objectives and Significance. Smartphones have the capability to monitor health-related behaviors (exercise, diet, etc.) and provide social support which has the potential to play a powerful role in health promotion. The objective of this study is to refine and pilot test the Social POD app for personalized health monitoring and interaction founded on a combination of social networks, recommender systems, motivational research, and health behavior theory. Currently, we are recruiting for usability testing among obese and overweight (BMI >25 kg/m2) adults (n=20) with our basic Social POD app. Our proposed project, which seeks to supplement our current line of research investigating mHealth interventions for overweight and obese adults, has two aims:
Aim 1: Refine our intelligent social agent mobile app (Social POD) based on results from our usability testing and develop new components (i.e., incentive system) for use in a 3-month randomized controlled pilot trial (RCT).
Aim 2: Conduct a 3-month pilot RCT among overweight and obese adults (N=150) comparing a theory-based podcast (TBP) plus self-monitoring using a commercially-available calorie and weight tracking app (current most popular diet self-monitoring method)9 versus TBP plus self-monitoring and social support/incentive points for participating with the Social POD app (TBP+Social POD).
Once the final intervention is developed through Aim 1 including the incentive system, we will recruit 150 overweight adult Android smartphone owners (BMI 25-49.9 kg/m2; age 18-65; >30% AA) to participate in a 3-month pilot of our enhanced intervention. Detecting differences in weight among the two groups is our primary research goal.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
South Carolina
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Columbia, South Carolina, United States, 29208
- University of South Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Overweight or obese (Body Mass Index between 25 and 49.9 kg/m2)
- Own and Android phone or tablet
Exclusion Criteria:
- are currently pregnant
- are younger than 18 or older than 65 years of age
- are unable to attend 3 meetings at the University of South Carolina
- don't have access to the Internet and a computer
- don't have access to a scale for self-monitoring weight
- aren't willing to be randomized to one of the two groups
- have a psychiatric disease, drug or alcohol dependency, or uncontrolled thyroid condition
- have a major health condition, such as heart conditions, diabetes, and past incidence of stroke
- have an eating disorder
- currently participating in a weight loss program or taking weight loss medications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Theory-based podcast
Receive a 3-month weight loss intervention delivered via theory-based podcast (TBP) plus self-monitoring using a commercially-available calorie and weight tracking app (current most popular diet self-monitoring method). Intervention: podcast + mobile diet app |
Use of a mobile app to track behaviors related to weight loss as well as receive study-related weight loss information via podcast.
|
Experimental: Theory-based podcast + Social POD
Receive a 3-month weight loss intervention delivered via Theory-based Podcast (TBP) plus self-monitoring and social support/incentive points for participating with the Social POD app (TBP+Social POD). Intervention: podcast + theory-based mobile diet app |
Use of a theory-based mobile app to track behaviors related to weight loss as well as receive study-related weight loss information via podcast.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weight loss
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Hales S, Turner-McGrievy GM, Wilcox S, Davis RE, Fahim A, Huhns M, Valafar H. Trading pounds for points: Engagement and weight loss in a mobile health intervention. Digit Health. 2017 Apr 24;3:2055207617702252. doi: 10.1177/2055207617702252. eCollection 2017 Jan-Dec.
- Hales S, Turner-McGrievy GM, Wilcox S, Fahim A, Davis RE, Huhns M, Valafar H. Social networks for improving healthy weight loss behaviors for overweight and obese adults: A randomized clinical trial of the social pounds off digitally (Social POD) mobile app. Int J Med Inform. 2016 Oct;94:81-90. doi: 10.1016/j.ijmedinf.2016.07.003. Epub 2016 Jul 2.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro00034960
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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