Clinical trial NCT02621008: Mobile Phone-based Intervention for Promoting Healthy Habits and Weight Loss
Official title: A Self-Administered Mobile Phone-based Holistic Intervention for Promoting Healthy Habits and Weight Loss in People Who Are Overweight or Obese
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Hypertension
Pre-diabetes
Overweight
Obese
Weight
Adherence
Keywords: diabetes
hypertension
obesity
mobile phone
stress
healthy living
pre-diabetes
Lead sponsor: Eco Fusion
Sponsor class: INDUSTRY
First posted: 2015-12-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Be 18 years of age or older and
* have a body mass index (BMI) of at least 24 kg/m2 (22 kg/m2 if Asian) and
* be able to engage in light physical activity

Exclusion Criteria:

* no Internet access or use of iOS
* taking more than three antihypertensive or diabetes drugs; meeting the DSM-5 criteria for an eating disorder
* having a disability that prevents or hinders exercise and physical activity
* receiving any treatment for weight loss elsewhere.

Primary outcomes:
measure: BMI
timeFrame: 16 weeks
measure: Glucose level
timeFrame: 16 weeks
measure: blood pressure
timeFrame: 16 weeks
measure: BMI
timeFrame: 6 months
measure: BMI
timeFrame: 12 months
measure: glucose level
timeFrame: 6 months
measure: glucose level
timeFrame: 12 months
measure: blood pressure
timeFrame: 6 months
measure: blood pressure
timeFrame: 12 months
Secondary outcomes:
measure: Quality of Life questionnaire
timeFrame: 16 weeks
measure: Quality of Life questionnaire
timeFrame: 6 months
measure: Quality of Life questionnaire
timeFrame: 12 months
measure: Burnout measure
timeFrame: 16 weeks
measure: Burnout Measure
timeFrame: 6 months
measure: Burnout measure
timeFrame: 12 months
measure: Perceived dietary adherence questionnaire
timeFrame: 16 weeks
measure: Perceived dietary adherence questionnaire
timeFrame: 6 months
measure: Perceived dietary adherence questionnaire
timeFrame: 12 months
measure: Mind wandering index
timeFrame: 16 weeks
measure: Mind wandering index
timeFrame: 6 months
measure: Mind wandering index
timeFrame: 1 year
measure: stress mindset scale
timeFrame: 16 weeks
measure: stress mindset scale
timeFrame: 6 months
measure: stress mindset scale
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Mt Sinai Medical Center
state: New York
Study officials:
References: