Clinical trial NCT02344836: The Social Pounds Off Digitally (Social POD) Study
Official title: Refining and Pilot Testing Social Networks for Encouraging Healthy Behaviors: The Social Pounds Off Digitally (Social POD) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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. The aim of our proposed project is to 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) versus TBP plus self-monitoring and social support/incentive points for participating with the Social POD app (TBP+Social POD).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight loss
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
References:
citation: 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.
citation: 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.