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

Primary Purpose

Diabetes, Hypertension, Pre-diabetes

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress Reduction& Healthy living
Sponsored by
Eco Fusion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring diabetes, hypertension, obesity, mobile phone, stress, healthy living, pre-diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mt Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stress Reduction& Healthy living

Arm Description

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.

Outcomes

Primary Outcome Measures

BMI
Glucose level
blood pressure
BMI
BMI
glucose level
glucose level
blood pressure
blood pressure

Secondary Outcome Measures

Quality of Life questionnaire
Quality of Life questionnaire
Quality of Life questionnaire
Burnout measure
Burnout Measure
Burnout measure
Perceived dietary adherence questionnaire
Perceived dietary adherence questionnaire
Perceived dietary adherence questionnaire
Mind wandering index
tendency and frequency of mind wandering
Mind wandering index
Mind wandering index
stress mindset scale
stress mindset scale
stress mindset scale

Full Information

First Posted
November 25, 2015
Last Updated
December 31, 2015
Sponsor
Eco Fusion
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1. Study Identification

Unique Protocol Identification Number
NCT02621008
Brief Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eco Fusion

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hypertension, Pre-diabetes, Overweight, Obese, Weight, Adherence
Keywords
diabetes, hypertension, obesity, mobile phone, stress, healthy living, pre-diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stress Reduction& Healthy living
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Stress Reduction& Healthy living
Intervention Description
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.
Primary Outcome Measure Information:
Title
BMI
Time Frame
16 weeks
Title
Glucose level
Time Frame
16 weeks
Title
blood pressure
Time Frame
16 weeks
Title
BMI
Time Frame
6 months
Title
BMI
Time Frame
12 months
Title
glucose level
Time Frame
6 months
Title
glucose level
Time Frame
12 months
Title
blood pressure
Time Frame
6 months
Title
blood pressure
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quality of Life questionnaire
Time Frame
16 weeks
Title
Quality of Life questionnaire
Time Frame
6 months
Title
Quality of Life questionnaire
Time Frame
12 months
Title
Burnout measure
Time Frame
16 weeks
Title
Burnout Measure
Time Frame
6 months
Title
Burnout measure
Time Frame
12 months
Title
Perceived dietary adherence questionnaire
Time Frame
16 weeks
Title
Perceived dietary adherence questionnaire
Time Frame
6 months
Title
Perceived dietary adherence questionnaire
Time Frame
12 months
Title
Mind wandering index
Description
tendency and frequency of mind wandering
Time Frame
16 weeks
Title
Mind wandering index
Time Frame
6 months
Title
Mind wandering index
Time Frame
1 year
Title
stress mindset scale
Time Frame
16 weeks
Title
stress mindset scale
Time Frame
6 months
Title
stress mindset scale
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
oren fuerst, ph.d.
Phone
6466526531
Email
oren@eco-fusion.com
Facility Information:
Facility Name
Mt Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
steven kaplan, md
Phone
646-652-6531
Email
drprostate@aol.com
First Name & Middle Initial & Last Name & Degree
oren fuerst, phd
Phone
6466526531
Email
oren@eco-fusion.com

12. IPD Sharing Statement

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

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