Effectiveness of PUSH Notifications From a Mobile App for Improving the Body Composition of Overweight or Obese Women. Protocol of a Three-armed Clinical Assay
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 主要终点
- Changes from baseline Fatty mass
研究概览
简要总结
A clinical three-armed assay has been established to permit an evaluation of the effectiveness of implementing PUSH notifications in the actions orientated towards improving body composition through the establishment of dietary patterns and an increase in physical activity.
详细描述
The use of mobile technology is already part of the investigator's daily life and its presence is increasing exponentially. The term mHealth (mobile health) was used and defined for the first time in 2000. This concept was subsequently employed in the 2010 mHealth Summit of the Foundation for National Institutes of Health (FNIH) to refer to "the provision of medical attention services through mobile communication devices". Around 40% of the over 300,000 applications available in the different apps stores are related to health themes, with those focused on the monitoring and management of diseases standing out. One of the characteristics of mobile applications is the sending and receiving of messages through a system of notifications known as "PUSH", that consists of requests appearing on the display of the Smartphone at a scheduled time, permitting them to be customizable both in their contents and at the time of sending them
PUSH notifications are pro-active as they offer visual and/or aural alerts to inform the recipient of a message or event received and invite them to act on them, even without the App being in use. On receiving the notification, the user can interact in different degrees, from simply reading it to answering it, thus permitting feedback. Also, there is evidence of the PUSH notifications being effective in communications between professionals.
The objective of this study is to compare the effect of the implementation of a monitoring system, goal to achieve, on physical activity in overweight and obese adults. A clinical three-armed assay has been established to permit an evaluation of the effectiveness of implementing PUSH notifications in the actions orientated towards improving body composition through the establishment of dietary patterns and an increase in physical activity.
Participants (n=90) will be recruited through outpatient from private clinics in Cádiz, Andalucía, Spain, as well as through community presentations. Overweight or obese and sedentary adult will be randomly assigned into three groups.
For 6 months, all of the adults shall follow the same diet with an identical distribution of macronutrients. There will be a weekly check up of weight, fat, body water and muscle mass for all of them. The status of the number of steps in Accupedo is also checked every week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Having a IMC >25,
- •Being sedentary and
- •Have not been submitted to a restrictive diet in the 6 months preceding this study.
- •Having a body fat percentage of ≥ 30%
排除标准
- •Suffered from type 2 diabetes or renal conditions
- •Being pregnancy or attempt at pregnancy,
- •Being in a maternal lactation period,
- •Not possessing a Smartphone with an operating system (Android or iOS) and available data connection did not participate in the study.
研究组 & 干预措施
Control Group (CG)
Education, modifying diet and light physical activity (LPA)
干预措施: Control Group (CG) (Behavioral)
Moderate physical activity group (MPA)
Education, modifying diet and moderate physical activity (MPA)
干预措施: Moderate physical activity group (MPA) (Behavioral)
Intense physical activity group (IPA)
Education, modifying diet and intense physical activity (IPA)
干预措施: Intense physical activity group (IPA) (Behavioral)
结局指标
主要结局
Changes from baseline Fatty mass
时间窗: At baseline (0 years) and followed for 2 years
Baseline mean Fatty mass values will be measured and compared at 3, 6, 12 and 24 months. Fatty mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a percentage.
Changes from baseline Free-fatty mass
时间窗: At baseline (0 years) and followed for 2 years
Baseline mean Free-fatty mass values will be measured and compared at 3, 6, 12 and 24 months. Free-fatty mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a percentage.
Changes from baseline Muscular Mass
时间窗: At baseline (0 years) and followed for 2 years
Baseline mean Muscular Mass values will be measured and compared at 3, 6, 12 and 24 months. Muscular Mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a Kg.
Changes from baseline Corporal Water
时间窗: At baseline (0 years) and followed for 2 years
Baseline mean Corporal Water values will be measured and compared at 3, 6, 12 and 24 months. Corporal Water will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a Kg.
Adherence to dietary pattern will be also measured through personal interview
时间窗: At baseline (0 years) and followed for 2 years
Participants will be subjected for an intervention based on nutritional (control group) and physical education (two intervention arms) during 24 months. Partial measures will be also taken every week. In the end of the trial, changes in dietary patterns will be measured comparing means differences between baselines, 3, 6, 12 and 24 months.
Changes from baseline BMI
时间窗: At baseline (0 years) and followed for 2 years
Baseline mean BMI values will be measured and compared at 3, 6, 12 and 24 months. BMI will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale
Adherence to physical activity patterns will be also measured through IPAQ (International Physical Activity Questionnaire)
时间窗: At baseline (0 years) and followed for 2 years
Participants will be subjected for an intervention based on nutritional (control group) and physical education (two intervention arms) during 24 months. Partial measures will be also taken every week. In the end of the trial, changes in physical activity will be measured comparing means differences between baselines, 3, 6, 12 and 24 months.
次要结局
未报告次要终点
研究者
Alberto Hernández de los Reyes
Principal Investigator
Universidad de Córdoba