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Pilot Trial of "My Meal Mate" (MMM), a Smartphone Application for Weight Loss

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ClinicalTrials.gov Identifier: NCT01744535
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : December 7, 2012
Sponsor:
Information provided by (Responsible Party):
Michelle Carter, University of Leeds

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Behavioral: "My Meal Mate" (smartphone application) Behavioral: Paper food diary Behavioral: Online food diary Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Trial of "My Meal Mate" (MMM), a Smartphone Application Designed to Facilitate Weight Loss.
Study Start Date : March 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Paper food diary Behavioral: Paper food diary
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.
Active Comparator: Online food diary Behavioral: Online food diary
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.
Experimental: "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.
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 receive instant nutritional feedback and feedback via text message.



Primary Outcome Measures :
  1. Adherence to the trial [ Time Frame: 6 months ]
    The number of completers in each group is a feasibility outcome.

  2. 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.


Secondary Outcome Measures :
  1. Weight change (kg) [ Time Frame: 6 months ]
    Weight (kg) has been objectively measured at baseline and 6 months.

  2. BMI change [ Time Frame: 6 months ]
    BMI(kg/m2) has been objectively measured at baseline and 6 months.

  3. change in body fat percentage [ Time Frame: 6 months ]
    Body fat (%) has been objectively measured at baseline and 6 months.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744535


Locations
United Kingdom
University of Leeds
Leeds, West Yorkshire, United Kingdom, LS29JT
Sponsors and Collaborators
University of Leeds
Investigators
Principal Investigator: Janet Cade, Professor University of Leeds

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michelle Carter, Research Dietitian, University of Leeds
ClinicalTrials.gov Identifier: NCT01744535     History of Changes
Other Study ID Numbers: G0802108
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: December 7, 2012
Last Verified: December 2012

Keywords provided by Michelle Carter, University of Leeds:
smartphone
smartphone app
smartphone application
obesity
overweight
self monitoring

Additional relevant MeSH terms:
Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes