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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01139255
Other study ID # 10-0930
Secondary ID
Status Completed
Phase Phase 1
First received June 4, 2010
Last updated June 2, 2011
Start date June 2010
Est. completion date February 2011

Study information

Verified date June 2011
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- 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)

- 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)

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Podcasting + mobile media
Use of a weight loss podcast designed with health behavior theory

Locations

Country Name City State
United States UNC-Chapel Hill Weight Research Center Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight loss 6 months No
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