Mobile Phone-based Intervention for Promoting Healthy Habits and Weight Loss

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02621008
• Other study ID #: 007
• Status: Recruiting
• Phase: N/A
• First received: November 25, 2015
• Last updated: December 31, 2015
• Start date: November 2015
• Est. completion date: October 2016

Study information

• Verified date: December 2015
• Source: Eco Fusion
• Contact: oren fuerst, ph.d.
• Phone: 6466526531
• Email: oren[@]eco-fusion.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adherence
• Diabetes
• Diabetes Mellitus
• Glucose Intolerance
• Hypertension
• Obese
• Overweight
• Pre-diabetes
• Prediabetic State
• Weight

Intervention

Other:
• Stress Reduction& Healthy living
Utilizing a stress reduction app (Serenita) and lifestyle intervention App (NewMe) and obtaining the NewMe guideline for healthy living, plus obtaining periodic messages regarding healthy living.

Locations

Country	Name	City	State
United States	Mt Sinai Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Eco Fusion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI		16 weeks	No
Primary	Glucose level		16 weeks	No
Primary	blood pressure		16 weeks	No
Primary	BMI		6 months	No
Primary	BMI		12 months	No
Primary	glucose level		6 months	No
Primary	glucose level		12 months	No
Primary	blood pressure		6 months	No
Primary	blood pressure		12 months	No
Secondary	Quality of Life questionnaire		16 weeks	No
Secondary	Quality of Life questionnaire		6 months	No
Secondary	Quality of Life questionnaire		12 months	No
Secondary	Burnout measure		16 weeks	No
Secondary	Burnout Measure		6 months	No
Secondary	Burnout measure		12 months	No
Secondary	Perceived dietary adherence questionnaire		16 weeks	No
Secondary	Perceived dietary adherence questionnaire		6 months	No
Secondary	Perceived dietary adherence questionnaire		12 months	No
Secondary	Mind wandering index	tendency and frequency of mind wandering	16 weeks	No
Secondary	Mind wandering index		6 months	No
Secondary	Mind wandering index		1 year	No
Secondary	stress mindset scale		16 weeks	No
Secondary	stress mindset scale		6 months	No
Secondary	stress mindset scale		1 year	No