Clinical trial NCT00415870: mDiet - Ecological Momentary Intervention of Diet Via Mobile Technology
Official title: Ecological Momentary Intervention of Diet Via Mobile Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: Overweight
Cell Phone
Technology
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2006-12-25
Enrollment: 65
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a NCI funded study which will develop and evaluate a cell phone application (mDIET) that can be used as an assessment and intervention tool to improve dietary behaviors and thus reduce weight in overweight and moderately obese (BMI 25-34.9) men and women ages 25-55.

Detailed description: This research will develop a technologically advanced system for monitoring and intervening on diet behaviors (e.g., food intake, weight). Interventions aimed at dietary change are missing a comparable, portable tool. Mobile technologies can help fill this gap by providing portable connectivity to expert systems that create specific tailored diet goals based on participant profiles. The expert system can 'push' intervention messages throughout the day during critical point-of-decision moments to aid in decision making among users. The portable device can 'pull' information through prompts and easy-to-use recording. This ecological momentary assessment + ecological momentary intervention format may further encourage healthy behaviors by prompting at critical decision points to improve dietary behaviors.

Eligibility criteria: Inclusion Criteria:

* Participants will be included if they:

  * Are age 25-55
  * Are overweight or moderately obese
  * Are with a BMI between 25.0-34.9 (as defined by the NIH report on Obesity (NIH 1998)
  * Are able to read (completion of at least the 6th grade) and speak English
  * Provide consent
  * Do not intend to become pregnant or move out of the county for the duration of the intervention (16 weeks).
* Participants will also be required to have a cell phone that is capable of supporting the mDIET application.
* Participants may be otherwise healthy or have one or more risk factors for CVD, including uncomplicated Type 2 diabetes but will not be enrolled if they have diagnosed CVD.

Exclusion Criteria:

Participants will be excluded from the study if they have any of the following conditions:

* An eating disorder
* Are currently pregnant
* Have a strict dietary regimen prescribed by their doctor that will not allow them to comply with intervention guidelines related to dietary changes.

Primary outcomes:
measure: Mean Weight (kg)
timeFrame: 4 months
Secondary outcomes:
measure: Program Satisfaction
timeFrame: 4 months
measure: Compliance With Food Monitoring Activities
timeFrame: 4 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Professional Suites
state: California
Study officials:
affiliation: UCSD
name: Kevin Patrick, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Norman GJ, Kolodziejczyk JK, Adams MA, Patrick K, Marshall SJ. Fruit and vegetable intake and eating behaviors mediate the effect of a randomized text-message based weight loss program. Prev Med. 2013 Jan;56(1):3-7. doi: 10.1016/j.ypmed.2012.10.012. Epub 2012 Oct 22.
citation: Patrick K, Raab F, Adams MA, Dillon L, Zabinski M, Rock CL, Griswold WG, Norman GJ. A text message-based intervention for weight loss: randomized controlled trial. J Med Internet Res. 2009 Jan 13;11(1):e1. doi: 10.2196/jmir.1100.