Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02621008
Recruitment Status : Unknown
Verified December 2015 by Eco Fusion.
Recruitment status was:  Recruiting
First Posted : December 3, 2015
Last Update Posted : January 1, 2016
Sponsor:
Information provided by (Responsible Party):
Eco Fusion

Tracking Information
First Submitted Date  ICMJE November 25, 2015
First Posted Date  ICMJE December 3, 2015
Last Update Posted Date January 1, 2016
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2015)
  • BMI [ Time Frame: 16 weeks ]
  • Glucose level [ Time Frame: 16 weeks ]
  • blood pressure [ Time Frame: 16 weeks ]
  • BMI [ Time Frame: 6 months ]
  • BMI [ Time Frame: 12 months ]
  • glucose level [ Time Frame: 6 months ]
  • glucose level [ Time Frame: 12 months ]
  • blood pressure [ Time Frame: 6 months ]
  • blood pressure [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02621008 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2015)
  • Quality of Life questionnaire [ Time Frame: 16 weeks ]
  • Quality of Life questionnaire [ Time Frame: 6 months ]
  • Quality of Life questionnaire [ Time Frame: 12 months ]
  • Burnout measure [ Time Frame: 16 weeks ]
  • Burnout Measure [ Time Frame: 6 months ]
  • Burnout measure [ Time Frame: 12 months ]
  • Perceived dietary adherence questionnaire [ Time Frame: 16 weeks ]
  • Perceived dietary adherence questionnaire [ Time Frame: 6 months ]
  • Perceived dietary adherence questionnaire [ Time Frame: 12 months ]
  • Mind wandering index [ Time Frame: 16 weeks ]
    tendency and frequency of mind wandering
  • Mind wandering index [ Time Frame: 6 months ]
  • Mind wandering index [ Time Frame: 1 year ]
  • stress mindset scale [ Time Frame: 16 weeks ]
  • stress mindset scale [ Time Frame: 6 months ]
  • stress mindset scale [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2015)
  • Quality of Life questionnaire [ Time Frame: 16 weeks 6 months and 1 year ]
  • Quality of Life questionnaire [ Time Frame: 6 months ]
  • Quality of Life questionnaire [ Time Frame: 12 months ]
  • Symptoms check questionnaire [ Time Frame: 16 weeks ]
  • Symptoms check questionnaire [ Time Frame: 6 months ]
  • Symptoms check questionnaire [ Time Frame: 12 months ]
  • Perceived dietary adherence questionnaire [ Time Frame: 16 weeks ]
  • Perceived dietary adherence questionnaire [ Time Frame: 6 months ]
  • Perceived dietary adherence questionnaire [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mobile Phone-based Intervention for Promoting Healthy Habits and Weight Loss
Official Title  ICMJE A Self-Administered Mobile Phone-based Holistic Intervention for Promoting Healthy Habits and Weight Loss in People Who Are Overweight or Obese
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Hypertension
  • Pre-diabetes
  • Overweight
  • Obese
  • Weight
  • Adherence
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Other: Stress Reduction& Healthy living
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 1, 2015)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2016
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02621008
Other Study ID Numbers  ICMJE 007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eco Fusion
Study Sponsor  ICMJE Eco Fusion
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Eco Fusion
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP