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

Obesity Clinical Trial

Official title:

Pilot Trial of "My Meal Mate" (MMM), a Smartphone Application Designed to Facilitate Weight Loss.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01744535
• Other study ID #: G0802108
• Status: Completed
• Phase: Phase 2
• First received: December 5, 2012
• Last updated: December 6, 2012
• Start date: March 2011
• Est. completion date: January 2012

Study information

• Verified date: December 2012
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Councils UK
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United Kingdom	University of Leeds	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Leeds

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to the trial	The number of completers in each group is a feasibility outcome.	6 months	No
Primary	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.	6 months	No
Secondary	Weight change (kg)	Weight (kg) has been objectively measured at baseline and 6 months.	6 months	No
Secondary	BMI change	BMI(kg/m2) has been objectively measured at baseline and 6 months.	6 months	No
Secondary	change in body fat percentage	Body fat (%) has been objectively measured at baseline and 6 months.	6 months	No