mDiet - Ecological Momentary Intervention of Diet Via Mobile Technology

Study Overview
=================
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.

Official Title
-----------------
Ecological Momentary Intervention of Diet Via Mobile Technology

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PACE<br>Received text messages and counseling calls | Behavioral: Printed Material<br>* Printed Material<br>Behavioral: Weekly Weighing<br>* Weekly Weighing<br>Behavioral: Cell phone will serve as a self monitoring device<br>* Cell phone will serve as a self monitoring device<br>Device: Text Message<br>* Text Message<br>Behavioral: Diet Goals via Cell Phone<br>* Diet Goals via Cell Phone<br>Behavioral: Food Monitoring<br>* Food Monitoring<br>|
| No Intervention: Control<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Weight (kg) |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 months | 
| Compliance With Food Monitoring Activities |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overweight, Cell Phone, Technology