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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-4148 UCSD Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PACE | Experimental | Received text messages and counseling calls |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Printed Material | Behavioral | Printed Material |
| |
| Weekly Weighing |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Weight (kg) | 4 months |
| 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 |
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Inclusion Criteria:
Participants will be included if they:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Patrick, MD, MS | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Professional Suites | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23085329 | Derived | 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. | |
| 19141433 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Enhanced Usual Care |
| FG001 | PACE | Received text messages and counseling calls Food Monitoring : Food Monitoring Text Message : Text Message Cell phone will serve as a self monitoring device : Cell phone will serve as a self monitoring device Diet Goals via Cell Phone : Diet Goals via Cell Phone Weekly Weighing : Weekly Weighing Printed Material : Printed Material |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control: Enhanced Usual Care | Enhanced usual care |
| BG001 | PACE: Intervention - SMS Messages and Lifestyle Counseling | Received text messages and counseling calls |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Weight (kg) | Posted | Mean | Standard Deviation | kg | 4 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Enhanced Usual Care |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Coordinator | UCSD | 858-534-9329 | ldillon@ucsd.edu |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Behavioral |
Weekly Weighing |
|
| Cell phone will serve as a self monitoring device | Behavioral | Cell phone will serve as a self monitoring device |
|
| Text Message | Device | Text Message |
|
| Diet Goals via Cell Phone | Behavioral | Diet Goals via Cell Phone |
|
| Food Monitoring | Behavioral | Food Monitoring |
|
| 4 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | 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. | Participants in the control condition did not receive the program satisfaction survey. For those in the PACE-intervention arm, it was not mandatory to complete the program satisfaction survey and thus the number of participants who completed it are reflected in the data submitted. | Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
|
|
| Secondary | Compliance With Food Monitoring Activities | We did not collect these data from the phone nor reported them in our main outcome paper. To the best of our recollection we shifted our emphasis from recording types of food and amounts of food to the behaviors of eating that were reflected in the Eating Behavior Inventory (O'Neill et al, 1979; citation #20 in the main outcome paper). | Posted | 4 months |
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | PACE | Received text messages and counseling calls | 0 | 33 | 0 | 33 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |