OverweightNCT00415870
mDiet - Ecological Momentary Intervention of Diet Via Mobile Technology
A study testing Printed Material, Weekly Weighing and Cell phone will serve as a self monitoring device in people with Overweight, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Overweight
- What is being tested?
- Printed Material, Weekly Weighing and Cell phone will serve as a self monitoring device
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Apr 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Professional Suites
La Jolla, California, 92037
About this study
Official title: Ecological Momentary Intervention of Diet Via Mobile Technology
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.
Read the 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.
- Conditions
- Overweight
- Being tested
- Printed Material, Weekly Weighing, Cell phone will serve as a self monitoring device, Text Message, Diet Goals via Cell Phone
- Keywords
- Overweight, Cell Phone, Technology
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Printed MaterialBehavioural
Printed Material
Weekly WeighingBehavioural
Weekly Weighing
Cell phone will serve as a self monitoring deviceBehavioural
Cell phone will serve as a self monitoring device
Text MessageDevice
Text Message
Diet Goals via Cell PhoneBehavioural
Diet Goals via Cell Phone
Food MonitoringBehavioural
Food Monitoring
| Study group | Role | What they receive |
|---|---|---|
| PACE | Experimental | Received text messages and counseling calls Receives: 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 |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Weight (kg)
Measured: 4 months
Secondary outcomes (2)
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.
Measured: 4 months
Compliance With Food Monitoring Activities
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2006 (estimated)
- Study startJun 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Patrick, University of California, San Diego
- Investigators
- Kevin Patrick, MD, MS, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415870
- Sponsor's protocol ID
- 1R21CA115615-01A1
- Other IDs
- 2005-4148 UCSD Number
- Status last verified
- Apr 2019
- First submitted
- 22 Dec 2006
- Last updated
- 30 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23085329Patrick 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.
PubMed 19141433
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ecological Momentary Intervention of Diet Via Mobile Technology
- ClinicalTrials.gov ID
- NCT00415870
- Acronym / sponsor ID
- 1R21CA115615-01A1
- Conditions
- Overweight
- Keywords
- Overweight, Cell Phone, Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 25 Dec 2006 (estimated)
- Results
- Posted 4 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PACE | Experimental | 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 MonitoringReceived text messages and counseling calls |
| Control | No intervention | – |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Printed MaterialPrinted Material | Behavioural | PACE |
| Weekly WeighingWeekly Weighing | Behavioural | PACE |
| Cell phone will serve as a self monitoring deviceCell phone will serve as a self monitoring device | Behavioural | PACE |
| Text MessageText Message | Device | PACE |
| Diet Goals via Cell PhoneDiet Goals via Cell Phone | Behavioural | PACE |
| Food MonitoringFood Monitoring | Behavioural | PACE |
Primary outcome
Mean Weight (kg)
Time frame: 4 months
2 secondary outcomes
Program Satisfaction
Time frame: 4 months
Compliance With Food Monitoring Activities
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23085329Norman 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.
- Derived from this study: PubMed 19141433Patrick 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Patrick, MD, MS principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Printed Material, Weekly Weighing and Cell phone will serve as a self monitoring device in people with Overweight, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Weight (kg) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00415870, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.