Overweight
Conditions
Keywords
Overweight, Cell Phone, Technology
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.
Interventions
BEHAVIORALPrinted Material
Printed Material
BEHAVIORALWeekly Weighing
Weekly Weighing
BEHAVIORALCell phone will serve as a self monitoring device
Cell phone will serve as a self monitoring device
DEVICEText Message
Text Message
BEHAVIORALDiet Goals via Cell Phone
Diet Goals via Cell Phone
BEHAVIORALFood Monitoring
Food Monitoring
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Weight (kg) | 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Program Satisfaction | 4 months | 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 | 4 months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control: Enhanced Usual Care Enhanced usual care | 32 |
| PACE: Intervention - SMS Messages and Lifestyle Counseling Received text messages and counseling calls | 33 |
| Total | 65 |
Baseline characteristics
| Characteristic | PACE: Intervention - SMS Messages and Lifestyle Counseling | Control: Enhanced Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 32 Participants | 65 Participants |
| Age, Continuous | 47.4 years STANDARD_DEVIATION 7.1 | 42.4 years STANDARD_DEVIATION 7.5 | 44.9 years STANDARD_DEVIATION 7.7 |
| Region of Enrollment United States | 33 participants | 32 participants | 65 participants |
| Sex: Female, Male Female | 25 Participants | 27 Participants | 52 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 33 |
| serious Total, serious adverse events | 0 / 32 | 0 / 33 |
Outcome results
Primary
Mean Weight (kg)
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control:Enhanced Usual Care | Mean Weight (kg) | 87.85 kg | Standard Deviation 14.11 |
| PACE: Intervention - SMS Messages | Mean Weight (kg) | 85.17 kg | Standard Deviation 18.16 |
Secondary
Compliance With Food Monitoring Activities
Time frame: 4 months
Population: 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).
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.
Time frame: 4 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PACE: Intervention - SMS Messages | Program Satisfaction | 1.88 score on a scale | Standard Deviation 0.44 |