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mDiet - Ecological Momentary Intervention of Diet Via Mobile Technology

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kevin Patrick, MD, MS, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00415870
First received: December 22, 2006
Last updated: June 20, 2013
Last verified: June 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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: 4 months ] [ Designated as safety issue: No ]

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: 4 months ] [ Designated as safety issue: No ]
  • 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: 4 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: June 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
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, see Learn About Clinical Studies.

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

No publications provided by University of California, San Diego

Additional 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: 1 R21 CA115615-01A1, 2005-4148 UCSD Number
Study First Received: December 22, 2006
Results First Received: June 20, 2013
Last Updated: June 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Overweight
Cell Phone
Technology

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014