Hypertension Clinical Trial
Official title:
A Self-Administered Mobile Phone-based Holistic Intervention for Promoting Healthy Habits and Weight Loss in People Who Are Overweight or Obese
A self administered 16 weeks plus follow up study to explore the efficacy of mobile phone driven apps for stress reduction coupled with guidance for healthy living among obese and overweight populations. The Study primary end points are weight of the participants, as well as glucose measurements (for subject with diabetes) and blood pressure (of subjects with hypertension).
The NewMe™ (Eco-fusion, Ltd) is a science driven lifestyle change program for better living
(www.eco-fusion.com).
What's in the program? It starts with two weeks to shakeup the patient. It is focused on
ridding the patient of known food addictions and helping the body patient return to its long
forgotten normal operating environment. The patient is expected to notice a dramatic change
in its well-being after those two weeks.
The NewMe program uses mobile health and motivational psychology to help impact sustainable
lifestyle changes. The program takes a holistic approach to the etiology of adverse
lifestyle habits and personalizes the solution to each individual. It is based on a variety
of clinical constructs, including multiple studies related to biofeedback and stress relief,
appended with the latest scientific development in nutrition and fitness, and enhanced with
a technology platform specifically developed to deliver such care. The goal of the program
is rapid and sustainable life changes with measurable parameters such as increased quality
of life, reduced stress level, improved blood pressure and cholesterol, blood sugar and
weight.
At the core of the system is a comprehensive clinical program combining nutrition, stress
management, fitness, and social support, guided by a suite of software apps and emails which
guide participants through a 16 weeks program, which is kick-started by a 2 weeks Rapid
Start up Regimen. The solution combines a structured program and interactions and teaches
participants how to integrate a healthier routine into their day-to-day life.
Core content include a broad behavioral focus on the principles of making healthy food
choices and meal planning, instructions on how to combine both healthy diet and inclusion of
an activity, stress & sleep tracker. Stress gets special attention with the integration of
breathing exercises, biofeedback training & meditation into a daily routine in order to
control and reduce emotional eating and other eating binges. This is done through the
Serenita App.
To promote behavior change, the program introduces the cognitive and behavioral strategies,
critical for long-term disease reversal. Other instructional content relates to the
importance of including a modified high-nutrient density and fiber, low- caloric density
foods in meal planning (although there is no caloric restriction in the program), managing
self-defeating thinking patterns, and incorporating both fat burning & strength training
into a physical activity regime.
The program is divided into 2 stages:
- Stage One - Week 1 & 2- Rapid Start up regimen, in which the participants follow a
nutrient rich, low processed and carbs dietary regimen.
- In addition, using a personalized sensor driven app, participants practice daily
breathing exercises & guided meditation, intended to manage stress, and control food
cravings. Physical activity regimen is also integrated into the daily routine. They
confirm and log their daily activity which is software guided
- Stage two, weeks 3-16. During this period some of the restricted foods in Stage one are
being reintroduced and the effect of reintroduction is explored.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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