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mDiet - Ecological Momentary Intervention of Diet Via Mobile Technology

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Printed Material
Weekly Weighing
Cell phone will serve as a self monitoring device
Text Message
Diet Goals via Cell Phone
Food Monitoring
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Overweight, Cell Phone, Technology

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCSD Professional Suites

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PACE

Control

Arm Description

Received text messages and counseling calls

Outcomes

Primary Outcome Measures

Mean Weight (kg)

Secondary Outcome Measures

Program Satisfaction
Participants reported a 2 if they liked the program, 1 if they felt neutral about the program, and 0 if they did not like program. Higher scores reflect greater satisfaction.
Compliance With Food Monitoring Activities

Full Information

First Posted
December 22, 2006
Last Updated
April 18, 2019
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT00415870
Brief Title
mDiet - Ecological Momentary Intervention of Diet Via Mobile Technology
Official Title
Ecological Momentary Intervention of Diet Via Mobile Technology
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Overweight, Cell Phone, Technology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PACE
Arm Type
Experimental
Arm Description
Received text messages and counseling calls
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Printed Material
Intervention Description
Printed Material
Intervention Type
Behavioral
Intervention Name(s)
Weekly Weighing
Intervention Description
Weekly Weighing
Intervention Type
Behavioral
Intervention Name(s)
Cell phone will serve as a self monitoring device
Intervention Description
Cell phone will serve as a self monitoring device
Intervention Type
Device
Intervention Name(s)
Text Message
Intervention Description
Text Message
Intervention Type
Behavioral
Intervention Name(s)
Diet Goals via Cell Phone
Intervention Description
Diet Goals via Cell Phone
Intervention Type
Behavioral
Intervention Name(s)
Food Monitoring
Intervention Description
Food Monitoring
Primary Outcome Measure Information:
Title
Mean Weight (kg)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Program Satisfaction
Description
Participants reported a 2 if they liked the program, 1 if they felt neutral about the program, and 0 if they did not like program. Higher scores reflect greater satisfaction.
Time Frame
4 months
Title
Compliance With Food Monitoring Activities
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Patrick, MD, MS
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Professional Suites
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23085329
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.
Results Reference
derived
PubMed Identifier
19141433
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.
Results Reference
derived

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mDiet - Ecological Momentary Intervention of Diet Via Mobile Technology

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