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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michelle Carter, University of Leeds
ClinicalTrials.gov Identifier:
NCT01744535
First received: December 5, 2012
Last updated: December 6, 2012
Last verified: December 2012

December 5, 2012
December 6, 2012
March 2011
January 2012   (final data collection date for primary outcome measure)
  • Adherence to the trial [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The number of completers in each group is a feasibility outcome.
  • Adherence to the intervention arms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The number of days with a plausible record of diet (>500-5000 kcal recorded) in each arm is a feasibility outcome.
Same as current
Complete list of historical versions of study NCT01744535 on ClinicalTrials.gov Archive Site
  • Weight change (kg) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Weight (kg) has been objectively measured at baseline and 6 months.
  • BMI change [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    BMI(kg/m2) has been objectively measured at baseline and 6 months.
  • change in body fat percentage [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Body fat (%) has been objectively measured at baseline and 6 months.
Same as current
Not Provided
Not Provided
 
Pilot Trial of "My Meal Mate" (MMM), a Smartphone Application for Weight Loss
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Obesity
  • Overweight
  • 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.
  • 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.
  • 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.
  • Active Comparator: Paper food diary
    Intervention: Behavioral: Paper food diary
  • Active Comparator: Online food diary
    Intervention: Behavioral: Online food diary
  • 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.
    Intervention: Behavioral: "My Meal Mate" (smartphone application)
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. 2012 May 3:1-8. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01744535
G0802108
No
Michelle Carter, University of Leeds
University of Leeds
Not Provided
Principal Investigator: Janet Cade, Professor University of Leeds
University of Leeds
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP