ObesityPhase 1SocialPODNCT02344836
The Social Pounds Off Digitally (Social POD) Study
A Phase 1 study testing Podcast + mobile diet app and Podcast + theory-based mobile diet app in people with Obesity, run by University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Podcast + mobile diet app and Podcast + theory-based mobile diet app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to May 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight or obese (Body Mass Index between 25 and 49.9 kg/m2)
- Own and Android phone or tablet
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: Refining and Pilot Testing Social Networks for Encouraging Healthy Behaviors: The Social Pounds Off Digitally (Social POD) Study
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).
Read the 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.
- Conditions
- Obesity
- Being tested
- Podcast + mobile diet app, Podcast + theory-based mobile diet app
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Podcast + mobile diet appBehavioural
Use of a mobile app to track behaviors related to weight loss as well as receive study-related weight loss information via podcast.
Podcast + theory-based mobile diet appBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Theory-based podcast | Active comparator | 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 Receives: Behavioral: Podcast + mobile diet app |
| Theory-based podcast + Social POD | Experimental | 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 Receives: Behavioral: Podcast + theory-based mobile diet app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brie Turner-McGrievy, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344836
- Sponsor's protocol ID
- Pro00034960
- Acronym
- SocialPOD
- Status last verified
- Jun 2015
- First submitted
- 16 Jan 2015
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29942590Hales 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.
PubMed 27573315
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refining and Pilot Testing Social Networks for Encouraging Healthy Behaviors: The Social Pounds Off Digitally (Social POD) Study
- ClinicalTrials.gov ID
- NCT02344836
- Acronym / sponsor ID
- SocialPOD / Pro00034960
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theory-based podcast | Active comparator | Behavioral: Podcast + mobile diet appReceive 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 |
| Theory-based podcast + Social POD | Experimental | Behavioral: Podcast + theory-based mobile diet appReceive 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Overweight or obese (Body Mass Index between 25 and 49.9 kg/m2)
- Own and Android phone or tablet
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Podcast + mobile diet appUse of a mobile app to track behaviors related to weight loss as well as receive study-related weight loss information via podcast. | Behavioural | Theory-based podcast |
| Podcast + theory-based mobile diet appUse of a theory-based mobile app to track behaviors related to weight loss as well as receive study-related weight loss information via podcast. | Behavioural | Theory-based podcast + Social POD |
Primary outcome
Weight loss
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Derived from this study: PubMed 29942590Hales 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.
- Derived from this study: PubMed 27573315Hales 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Podcast + mobile diet app and Podcast + theory-based mobile diet app in people with Obesity, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02344836, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015.