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临床试验/NCT01744535
NCT01744535已完成2 期

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

University of Leeds1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2011年3月1日最近更新:
适应症
干预措施

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

Active Comparator

干预措施: Paper food diary (Behavioral)

Online food diary

Active Comparator

干预措施: Online food diary (Behavioral)

"My Meal Mate" (smartphone application)

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michelle Carter

Research Dietitian

University of Leeds

研究点 (1)

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