Clinical trial NCT01744535: Pilot Trial of "My Meal Mate" (MMM), a Smartphone Application for Weight Loss
Official title: Pilot Trial of "My Meal Mate" (MMM), a Smartphone Application Designed to Facilitate Weight Loss.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Overweight
Keywords: smartphone
smartphone app
smartphone application
obesity
overweight
self monitoring
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Adherence to the trial
timeFrame: 6 months
measure: Adherence to the intervention arms
timeFrame: 6 months
Secondary outcomes:
measure: Weight change (kg)
timeFrame: 6 months
measure: BMI change
timeFrame: 6 months
measure: change in body fat percentage
timeFrame: 6 months
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: University of Leeds
state: West Yorkshire
Study officials:
affiliation: University of Leeds
name: Janet Cade, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Carter 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.
citation: Carter 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.