ObesityPhase 1PODNCT01139255
Pounds Off Digitally (POD): The Use of Podcasting and Mobile Media to Promote Weight Loss
A Phase 1 study testing Podcasting + mobile media in people with Obesity and Overweight, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Overweight and obesity play a role in both cancer incidence and survival rates. Many people have found attending weight loss support groups to be time-intensive. Past research has shown electronic media, particularly the Web, to be effective in producing weight loss. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Podcasting + mobile media
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Feb 2011
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- be between the ages of 18-60 years old
- be a non-smoker
- live in the Chapel Hill, NC area
- be able to attend monitoring visits at baseline, 3-months, and 6-months
- have access to the Internet and a computer
- have access to an Internet-capable mobile device (such as an iPhone, iPod Touch, or Blackberry) and an MP3 player (this may be the same device)
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- have access to a scale for self-monitoring weight
- be willing to be randomized to either group
- be free of psychiatric diseases, drug or alcohol dependency, or uncontrolled thyroid conditions
- be free of major health conditions, such as heart conditions, diabetes, and past incidence of stroke
- have MD consent for participation if currently on blood pressure medications, have issues with dizziness, or have bone or joint issues.
- able to prepare all their own meals (i.e. not living on-campus)
Who cannot join
- should not be pregnant, anticipating on becoming pregnant in the next 7 months, or currently breastfeeding
- be free of an eating disorder as screened by the Eating disorder Screen for Primary care [ESP].
- no current participation in a weight loss program or taking weight loss medications (although participants may be trying to lose weight on their own)
- have not participated in previous podcasting weight loss research
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC-Chapel Hill Weight Research Center
Chapel Hill, North Carolina, 27599
About this study
Official title: The Use of Podcasting and Mobile Media to Promote Weight Loss and Increase Fruit and Vegetable Intake Among Overweight Adults
Overweight and obesity play a role in both cancer incidence and survival rates. Many people have found attending weight loss support groups to be time-intensive. Past research has shown electronic media, particularly the Web, to be effective in producing weight loss. The Web, however, lacks portability, which prevents people from accessing the information when it is convenient for them. Providing weight loss information via podcasting (audio files that may be listened to on portable audio players) may allow people to receive weight loss tips anywhere. A previous research study showed that podcasts emphasizing healthy eating and exercise can help people lose weight. This study was short-term and did not include additional social support. The purpose of this research project is to assess the effectiveness of a weight loss intervention delivered through podcasts as compared to the same podcast with added mobile media such as self-monitoring software (such as a pedometer) and support delivered via a social networking site. For this research study, the investigators will conduct a 6-month study in 104 overweight adults to determine if a podcast plus mobile media support leads to greater weight loss than a podcast alone.
- Conditions
- Obesity, Overweight
- Being tested
- Podcasting + mobile media
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Podcasting + mobile mediaBehavioural
Use of a weight loss podcast designed with health behavior theory
| Study group | Role | What they receive |
|---|---|---|
| Podcasting + mobile media | Experimental | Not described Receives: Behavioral: Podcasting + mobile media |
| Podcasting | Active comparator | Not described Receives: Behavioral: Podcasting + mobile media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 North Carolina, Chapel HillThe 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Investigators
- Brie Turner-McGrievy, PhD, MS, RD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139255
- Sponsor's protocol ID
- 10-0930
- Acronym
- POD
- Status last verified
- Jun 2011
- First submitted
- 4 Jun 2010
- Last updated
- 6 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Turner-McGrievy G, Tate D. Tweets, Apps, and Pods: Results of the 6-month Mobile Pounds Off Digitally (Mobile POD) randomized weight-loss intervention among adults. J Med Internet Res. 2011 Dec 20;13(4):e120. doi: 10.2196/jmir.1841.
PubMed 22186428
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Podcasting and Mobile Media to Promote Weight Loss and Increase Fruit and Vegetable Intake Among Overweight Adults
- ClinicalTrials.gov ID
- NCT01139255
- Acronym / sponsor ID
- POD / 10-0930
- Conditions
- Obesity, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 8 Jun 2010 (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.
Overweight and obesity play a role in both cancer incidence and survival rates. Many people have found attending weight loss support groups to be time-intensive. Past research has shown electronic media, particularly the Web, to be effective in producing weight loss. The Web, however, lacks portability, which prevents people from accessing the information when it is convenient for them. Providing weight loss information via podcasting (audio files that may be listened to on portable audio players) may allow people to receive weight loss tips anywhere. A previous research study showed that podcasts emphasizing healthy eating and exercise can help people lose weight. This study was short-term and did not include additional social support. The purpose of this research project is to assess the effectiveness of a weight loss intervention delivered through podcasts as compared to the same podcast with added mobile media such as self-monitoring software (such as a pedometer) and support delivered via a social networking site. For this research study, the investigators will conduct a 6-month study in 104 overweight adults to determine if a podcast plus mobile media support leads to greater weight loss than a podcast alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Podcasting + mobile media | Experimental | Behavioral: Podcasting + mobile media |
| Podcasting | Active comparator | Behavioral: Podcasting + mobile media |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- be between the ages of 18-60 years old
- be a non-smoker
- live in the Chapel Hill, NC area
- be able to attend monitoring visits at baseline, 3-months, and 6-months
- have access to the Internet and a computer
Key exclusion criteria (4 listed)
- should not be pregnant, anticipating on becoming pregnant in the next 7 months, or currently breastfeeding
- be free of an eating disorder as screened by the Eating disorder Screen for Primary care [ESP].
- no current participation in a weight loss program or taking weight loss medications (although participants may be trying to lose weight on their own)
- have not participated in previous podcasting weight loss research
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 |
|---|---|---|
| Podcasting + mobile mediaUse of a weight loss podcast designed with health behavior theory | Behavioural | Podcasting, Podcasting + mobile media |
Primary outcome
Weight loss
Time frame: 6 months
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 6 Jun 2011.
- Derived from this study: PubMed 22186428Turner-McGrievy G, Tate D. Tweets, Apps, and Pods: Results of the 6-month Mobile Pounds Off Digitally (Mobile POD) randomized weight-loss intervention among adults. J Med Internet Res. 2011 Dec 20;13(4):e120. doi: 10.2196/jmir.1841.
- Related InfoLink provided by the sponsor.
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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.
Brie Turner-McGrievy, PhD, MS, RD principal investigator
University of North Carolina, Chapel Hill
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 Podcasting + mobile media in people with Obesity and Overweight, run by University of North Carolina, Chapel Hill 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 12 inclusion and 4 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 6 Jun 2011. 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: 6 months). 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 NCT01139255, which also lists 1 linked publication.
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 6 Jun 2011.