ClinicalTrials.gov
ClinicalTrials.gov Menu

mDiet - Ecological Momentary Intervention of Diet Via Mobile Technology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00415870
Recruitment Status : Completed
First Posted : December 25, 2006
Results First Posted : September 4, 2013
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Kevin Patrick, MD, MS, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ecological Momentary Intervention of Diet Via Mobile Technology
Study Start Date : June 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Arm Intervention/treatment
Experimental: PACE
Received text messages and counseling calls
Behavioral: Printed Material
Printed Material

Behavioral: Weekly Weighing
Weekly Weighing

Behavioral: Cell phone will serve as a self monitoring device
Cell phone will serve as a self monitoring device

Device: Text Message
Text Message

Behavioral: Diet Goals via Cell Phone
Diet Goals via Cell Phone

Behavioral: Food Monitoring
Food Monitoring

No Intervention: Control



Primary Outcome Measures :
  1. Mean Weight (kg) [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Compliance With Food Monitoring Activities (e.g, Type of Food, Amount) [ Time Frame: 4 months ]
  2. Program Satisification [ Time Frame: 4 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kevin Patrick, MD, MS, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00415870     History of Changes
Other Study ID Numbers: 1R21CA115615-01A1 ( U.S. NIH Grant/Contract )
2005-4148 UCSD Number
First Posted: December 25, 2006    Key Record Dates
Results First Posted: September 4, 2013
Last Update Posted: December 13, 2017
Last Verified: November 2017

Keywords provided by Kevin Patrick, MD, MS, University of California, San Diego:
Overweight
Cell Phone
Technology

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms