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

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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

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).

Condition or disease Intervention/treatment Phase
Diabetes Hypertension Pre-diabetes Overweight Obese Weight Adherence Other: Stress Reduction& Healthy living Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. BMI [ Time Frame: 16 weeks ]
  2. Glucose level [ Time Frame: 16 weeks ]
  3. blood pressure [ Time Frame: 16 weeks ]
  4. BMI [ Time Frame: 6 months ]
  5. BMI [ Time Frame: 12 months ]
  6. glucose level [ Time Frame: 6 months ]
  7. glucose level [ Time Frame: 12 months ]
  8. blood pressure [ Time Frame: 6 months ]
  9. blood pressure [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Quality of Life questionnaire [ Time Frame: 16 weeks ]
  2. Quality of Life questionnaire [ Time Frame: 6 months ]
  3. Quality of Life questionnaire [ Time Frame: 12 months ]
  4. Burnout measure [ Time Frame: 16 weeks ]
  5. Burnout Measure [ Time Frame: 6 months ]
  6. Burnout measure [ Time Frame: 12 months ]
  7. Perceived dietary adherence questionnaire [ Time Frame: 16 weeks ]
  8. Perceived dietary adherence questionnaire [ Time Frame: 6 months ]
  9. Perceived dietary adherence questionnaire [ Time Frame: 12 months ]
  10. Mind wandering index [ Time Frame: 16 weeks ]
    tendency and frequency of mind wandering

  11. Mind wandering index [ Time Frame: 6 months ]
  12. Mind wandering index [ Time Frame: 1 year ]
  13. stress mindset scale [ Time Frame: 16 weeks ]
  14. stress mindset scale [ Time Frame: 6 months ]
  15. stress mindset scale [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02621008


Contacts
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Contact: oren fuerst, ph.d. 6466526531 oren@eco-fusion.com

Locations
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United States, New York
Mt Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: steven kaplan, md    646-652-6531    drprostate@aol.com   
Contact: oren fuerst, phd    6466526531    oren@eco-fusion.com   
Sponsors and Collaborators
Eco Fusion

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Responsible Party: Eco Fusion
ClinicalTrials.gov Identifier: NCT02621008     History of Changes
Other Study ID Numbers: 007
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: December 2015
Keywords provided by Eco Fusion:
diabetes
hypertension
obesity
mobile phone
stress
healthy living
pre-diabetes
Additional relevant MeSH terms:
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Hypertension
Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Body Weight
Overweight
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Body Weight Changes
Hyperglycemia