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

December 31, 2015 updated by: Eco Fusion

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mt Sinai Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood pressure
Time Frame: 6 months
6 months
blood pressure
Time Frame: 16 weeks
16 weeks
BMI
Time Frame: 16 weeks
16 weeks
Glucose level
Time Frame: 16 weeks
16 weeks
BMI
Time Frame: 6 months
6 months
BMI
Time Frame: 12 months
12 months
glucose level
Time Frame: 6 months
6 months
glucose level
Time Frame: 12 months
12 months
blood pressure
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life questionnaire
Time Frame: 16 weeks
16 weeks
Quality of Life questionnaire
Time Frame: 6 months
6 months
Quality of Life questionnaire
Time Frame: 12 months
12 months
Burnout measure
Time Frame: 16 weeks
16 weeks
Burnout Measure
Time Frame: 6 months
6 months
Burnout measure
Time Frame: 12 months
12 months
Perceived dietary adherence questionnaire
Time Frame: 16 weeks
16 weeks
Perceived dietary adherence questionnaire
Time Frame: 6 months
6 months
Perceived dietary adherence questionnaire
Time Frame: 12 months
12 months
Mind wandering index
Time Frame: 16 weeks
tendency and frequency of mind wandering
16 weeks
Mind wandering index
Time Frame: 6 months
6 months
Mind wandering index
Time Frame: 1 year
1 year
stress mindset scale
Time Frame: 16 weeks
16 weeks
stress mindset scale
Time Frame: 6 months
6 months
stress mindset scale
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eco Fusion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

November 25, 2015

First Submitted That Met QC Criteria

December 1, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Estimate)

January 1, 2016

Last Update Submitted That Met QC Criteria

December 31, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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