Pilot Trial of "My Meal Mate" (MMM), a Smartphone Application Designed to Facilitate Weight Loss.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Adherence to the trial
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Paper food diary
干预措施: Paper food diary (Behavioral)
Online food diary
干预措施: Online food diary (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.
干预措施: "My Meal Mate" (smartphone application) (Behavioral)
结局指标
主要结局
Adherence to the trial
时间窗: 6 months
The number of completers in each group is a feasibility outcome.
Adherence to the intervention arms
时间窗: 6 months
The number of days with a plausible record of diet (\>500-5000 kcal recorded) in each arm is a feasibility outcome.
次要结局
- Weight change (kg)(6 months)
- BMI change(6 months)
- change in body fat percentage(6 months)
研究者
Michelle Carter
Research Dietitian
University of Leeds
