mDiet - Ecological Momentary Intervention of Diet Via Mobile Technology - Full Text View

Sponsored by:	University of California, San Diego
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00415870

Purpose

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.

Condition	Intervention
Overweight	Behavioral: Printed Material Behavioral: Weekly Weighing Behavioral: Cell phone will serve as a self monitoring device Device: Text Message Behavioral: Diet Goals via Cell Phone Behavioral: Food Monitoring

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Ecological Momentary Intervention of Diet Via Mobile Technology

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:

The primary outcome will be the effect of the mDIET system in comparison to a control group on BMI among overweight men and women. [ Time Frame: 9/5/06 - 7/31/08 ]

Secondary Outcome Measures:

to assess compliance with food monitoring activities (e.g, type of food, amount) via the cell phone. Compliance will be measured as a percentage of monitoring logs completed and submitted via phone [ Time Frame: 9/5/06 - 7/31/08 ]
to assess satisfaction with mDIET. Satisfaction will be measured by subjective ratings of intervention components and ease of use, and objective measures of frequency of use. [ Time Frame: 9/5/06-7/31/08 ]

Enrollment:	60
Study Start Date:	June 2007
Estimated Study Completion Date:	February 2008

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

Ages Eligible for Study:	25 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415870

Locations

United States, California
UCSD Professional Suites
La Jolla, California, United States, 92037

Sponsors and Collaborators

University of California, San Diego

Investigators

Principal Investigator:

Kevin Patrick, MD, MS

UCSD

More Information

Study ID Numbers:	1 R21 CA115615-01A1, 2005-4148 UCSD Number
Study First Received:	December 22, 2006
Last Updated:	November 8, 2007
ClinicalTrials.gov Identifier:	NCT00415870
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Diego:

Overweight
Cell Phone
Technology

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Overweight

ClinicalTrials.gov processed this record on January 16, 2009