ObesityPhase 2NCT01744535
Pilot Trial of "My Meal Mate" (MMM), a Smartphone Application for Weight Loss
A Phase 2 study testing "My Meal Mate" (smartphone application), Paper food diary and Online food diary in people with Obesity and Overweight, run by University of Leeds at 1 site in United Kingdom.
Trial summary
The aim of this study is to implement an exploratory pilot trial of "My Meal Mate" (MMM), a smartphone application developed to facilitate weight loss, assessing its feasibility and acceptability. Overweight and obese adults will be recruited from large employers within the local area. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- "My Meal Mate" (smartphone application), Paper food diary and Online food diary
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to Jan 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-65
- BMI equal to or greater than 27 kg/m2
- Willing to commit the necessary time and effort to the study,
- Employed by a large employer in Leeds (and expects to continue to be employed there for the next 12 months),
- Able to read and write in English,
- Able to access the internet,
- Willing to be randomised to one of three groups.
Who cannot join
- Pregnant, planning a pregnancy within next 12 months, lactating
- Has had surgery for weight loss
- Taking the medication sertraline (due to associations with weight gain)
- Taking anti-obesity medications or medications for diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Trial of "My Meal Mate" (MMM), a Smartphone Application Designed to Facilitate Weight Loss.
The aim of this study is to implement an exploratory pilot trial of "My Meal Mate" (MMM), a smartphone application developed to facilitate weight loss, assessing its feasibility and acceptability. Overweight and obese adults will be recruited from large employers within the local area. The trial will aim to recruit a sample size of 135 which is a pragmatic decision based on randomizing 45 people to each arm. Participants will be randomized to one of three groups. The researchers have developed a smartphone application for weight loss called "My Meal Mate" (MMM) which incorporates a large branded food and drink database. MMM was developed using focus group data collected from potential system users and by benchmarking with similar commercially available diet tracking applications. One group will receive a smartphone with the MMM app downloaded on it, one group will receive access to an online food diary and one group will be given a paper food diary. Participants will be asked to set a goal for weight loss and self-monitor their food intake and activity using their allocated study equipment. Participants will be weighed at the beginning of the trial, at 6 weeks and at 6 months. Feasibility and acceptability outcomes will be assessed.
- Conditions
- Obesity, Overweight
- Being tested
- "My Meal Mate" (smartphone application), Paper food diary, Online food diary
- Keywords
- smartphone, smartphone app, smartphone application, obesity, overweight, self monitoring
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"My Meal Mate" (smartphone application)Behavioural
A smartphone application called "My Meal Mate" (MMM) designed to facilitate weight loss. The app allows system users to set a goal for weight loss and self monitor diet and activity in an electronic diary. Users receive instant nutritional feedback and feedback via text message.
Paper food diaryBehavioural
The paper food diary is provided by a commerical slimming organisation called "Weight Loss Resources". The diary allows the user to record daily food and drink consumed. It is accompanied by a book which provides a database of the nutritional content of 40,000 food and drinks. The diary also encourages participants to record their physical activity.
Online food diaryBehavioural
The online food diary is provided by a commerical slimming organisation called "Weight Loss Resources". The electronic diary allows the user to record daily food and drink consumed. System users are also encouraged to record their physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Paper food diary | Active comparator | Not described Receives: Behavioral: Paper food diary |
| Online food diary | Active comparator | Not described Receives: Behavioral: Online food diary |
| "My Meal Mate" (smartphone application) | Experimental | A smartphone application called "My Meal Mate" (MMM) designed to facilitate weight loss. The app allows system users to set a goal for weight loss and self monitor diet and activity in an electronic diary. Users can select foods from the large "Weight Loss Resources" food database. Instant nutritional feedback is provided along with weekly feedback by text message. Receives: Behavioral: "My Meal Mate" (smartphone application) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the trial
The number of completers in each group is a feasibility outcome.
Measured: 6 months
Adherence to the intervention arms
The number of days with a plausible record of diet (>500-5000 kcal recorded) in each arm is a feasibility outcome.
Measured: 6 months
Secondary outcomes (3)
Weight change (kg)
Weight (kg) has been objectively measured at baseline and 6 months.
Measured: 6 months
BMI change
BMI(kg/m2) has been objectively measured at baseline and 6 months.
Measured: 6 months
change in body fat percentage
Body fat (%) has been objectively measured at baseline and 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startMar 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Carter, University of Leeds
- Investigators
- Janet Cade, Professor, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744535
- Sponsor's protocol ID
- G0802108
- Status last verified
- Dec 2012
- First submitted
- 5 Dec 2012
- Last updated
- 7 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Carter MC, Burley VJ, Nykjaer C, Cade JE. 'My Meal Mate' (MMM): validation of the diet measures captured on a smartphone application to facilitate weight loss. Br J Nutr. 2013 Feb 14;109(3):539-46. doi: 10.1017/S0007114512001353. Epub 2012 May 3.
PubMed 22717334Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.
PubMed 38375882Carter MC, Burley VJ, Cade JE. Weight Loss Associated With Different Patterns of Self-Monitoring Using the Mobile Phone App My Meal Mate. JMIR Mhealth Uhealth. 2017 Feb 2;5(2):e8. doi: 10.2196/mhealth.4520.
PubMed 28153814Carter MC, Burley VJ, Nykjaer C, Cade JE. Adherence to a smartphone application for weight loss compared to website and paper diary: pilot randomized controlled trial. J Med Internet Res. 2013 Apr 15;15(4):e32. doi: 10.2196/jmir.2283.
PubMed 23587561
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of "My Meal Mate" (MMM), a Smartphone Application Designed to Facilitate Weight Loss.
- ClinicalTrials.gov ID
- NCT01744535
- Acronym / sponsor ID
- G0802108
- Conditions
- Obesity, Overweight
- Keywords
- smartphone, smartphone app, smartphone application, obesity, overweight, self monitoring
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to implement an exploratory pilot trial of "My Meal Mate" (MMM), a smartphone application developed to facilitate weight loss, assessing its feasibility and acceptability. Overweight and obese adults will be recruited from large employers within the local area. The trial will aim to recruit a sample size of 135 which is a pragmatic decision based on randomizing 45 people to each arm. Participants will be randomized to one of three groups. The researchers have developed a smartphone application for weight loss called "My Meal Mate" (MMM) which incorporates a large branded food and drink database. MMM was developed using focus group data collected from potential system users and by benchmarking with similar commercially available diet tracking applications. One group will receive a smartphone with the MMM app downloaded on it, one group will receive access to an online food diary and one group will be given a paper food diary. Participants will be asked to set a goal for weight loss and self-monitor their food intake and activity using their allocated study equipment. Participants will be weighed at the beginning of the trial, at 6 weeks and at 6 months. Feasibility and acceptability outcomes will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paper food diary | Active comparator | Behavioral: Paper food diary |
| Online food diary | Active comparator | Behavioral: Online food diary |
| "My Meal Mate" (smartphone application) | Experimental | Behavioral: "My Meal Mate" (smartphone application)A smartphone application called "My Meal Mate" (MMM) designed to facilitate weight loss. The app allows system users to set a goal for weight loss and self monitor diet and activity in an electronic diary. Users can select foods from the large "Weight Loss Resources" food database. Instant nutritional feedback is provided along with weekly feedback by text message. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18-65
- BMI equal to or greater than 27 kg/m2
- Willing to commit the necessary time and effort to the study,
- Employed by a large employer in Leeds (and expects to continue to be employed there for the next 12 months),
- Able to read and write in English,
Key exclusion criteria (4 listed)
- Pregnant, planning a pregnancy within next 12 months, lactating
- Has had surgery for weight loss
- Taking the medication sertraline (due to associations with weight gain)
- Taking anti-obesity medications or medications for diabetes
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 |
|---|---|---|
| "My Meal Mate" (smartphone application)A smartphone application called "My Meal Mate" (MMM) designed to facilitate weight loss. The app allows system users to set a goal for weight loss and self monitor diet and activity in an electronic diary. Users receive instant nutritional feedback and feedback via text message. | Behavioural | "My Meal Mate" (smartphone application) |
| Paper food diaryThe paper food diary is provided by a commerical slimming organisation called "Weight Loss Resources". The diary allows the user to record daily food and drink consumed. It is accompanied by a book which provides a database of the nutritional content of 40,000 food and drinks. The diary also encourages participants to record their physical activity. | Behavioural | Paper food diary |
| Online food diaryThe online food diary is provided by a commerical slimming organisation called "Weight Loss Resources". The electronic diary allows the user to record daily food and drink consumed. System users are also encouraged to record their physical activity. | Behavioural | Online food diary |
Primary outcome
Adherence to the trial
Time frame: 6 months
The number of completers in each group is a feasibility outcome.
Adherence to the intervention arms
Time frame: 6 months
The number of days with a plausible record of diet (>500-5000 kcal recorded) in each arm is a feasibility outcome.
3 secondary outcomes
Weight change (kg)
Time frame: 6 months
BMI change
Time frame: 6 months
change in body fat percentage
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2012.
- Background: PubMed 22717334Carter MC, Burley VJ, Nykjaer C, Cade JE. 'My Meal Mate' (MMM): validation of the diet measures captured on a smartphone application to facilitate weight loss. Br J Nutr. 2013 Feb 14;109(3):539-46. doi: 10.1017/S0007114512001353. Epub 2012 May 3.
- Derived from this study: PubMed 38375882Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.
- Derived from this study: PubMed 28153814Carter MC, Burley VJ, Cade JE. Weight Loss Associated With Different Patterns of Self-Monitoring Using the Mobile Phone App My Meal Mate. JMIR Mhealth Uhealth. 2017 Feb 2;5(2):e8. doi: 10.2196/mhealth.4520.
- Derived from this study: PubMed 23587561Carter MC, Burley VJ, Nykjaer C, Cade JE. Adherence to a smartphone application for weight loss compared to website and paper diary: pilot randomized controlled trial. J Med Internet Res. 2013 Apr 15;15(4):e32. doi: 10.2196/jmir.2283.
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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.
Janet Cade, Professor principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing "My Meal Mate" (smartphone application), Paper food diary and Online food diary in people with Obesity and Overweight, run by University of Leeds at 1 site in United Kingdom.
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 7 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 7 Dec 2012. 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 Kingdom. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adherence to the trial (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT01744535, which also lists 4 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 7 Dec 2012.