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DiabetesNCT02621008

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

A study testing Stress Reduction& Healthy living in people with Diabetes and Hypertension, run by Eco Fusion at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes, Hypertension, Pre-diabetes
What is being tested?
Stress Reduction& Healthy living
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteUnited States
Study dates
Nov 2015to Oct 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

oren fuerst, ph.d. contact

6466526531

oren@eco-fusion.com

United States1 site, 1 recruiting
  • Mt Sinai Medical Center

    New York, New York, 10029

    steven kaplan, md, 646-652-6531, drprostate@aol.com

    oren fuerst, phd, 6466526531, oren@eco-fusion.com

    Recruiting

Other trials in United States

About this study

Official title: 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).

Read the 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.
Being tested
Stress Reduction& Healthy living
Keywords
diabetes, hypertension, obesity, mobile phone, stress, healthy living, pre-diabetes
Medical subject headings
Diabetes Mellitus, Hypertension, Glucose Intolerance, Overweight, Obesity, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stress Reduction& Healthy livingOther

    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 groups in NCT02621008
Study groupRoleWhat they receive
Stress Reduction& Healthy livingExperimentalUtilizing 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.
Receives: Other: Stress Reduction& Healthy living

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BMI

    Measured: 16 weeks

  2. Glucose level

    Measured: 16 weeks

  3. blood pressure

    Measured: 16 weeks

  4. BMI

    Measured: 6 months

  5. BMI

    Measured: 12 months

  6. glucose level

    Measured: 6 months

  7. glucose level

    Measured: 12 months

  8. blood pressure

    Measured: 6 months

  9. blood pressure

    Measured: 12 months

Secondary outcomes (15)
  1. Quality of Life questionnaire

    Measured: 16 weeks

  2. Quality of Life questionnaire

    Measured: 6 months

  3. Quality of Life questionnaire

    Measured: 12 months

  4. Burnout measure

    Measured: 16 weeks

  5. Burnout Measure

    Measured: 6 months

  6. Burnout measure

    Measured: 12 months

  7. Perceived dietary adherence questionnaire

    Measured: 16 weeks

  8. Perceived dietary adherence questionnaire

    Measured: 6 months

  9. Perceived dietary adherence questionnaire

    Measured: 12 months

  10. Mind wandering index

    tendency and frequency of mind wandering

    Measured: 16 weeks

  11. Mind wandering index

    Measured: 6 months

  12. Mind wandering index

    Measured: 1 year

  13. stress mindset scale

    Measured: 16 weeks

  14. stress mindset scale

    Measured: 6 months

  15. stress mindset scale

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionAug 2016 (estimated)
  4. Study completionOct 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02621008
Sponsor's protocol ID
007
Status last verified
Dec 2015
First submitted
25 Nov 2015
Last updated
1 Jan 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Stress Reduction& Healthy living in people with Diabetes and Hypertension, run by Eco Fusion at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact oren fuerst, ph.d. (6466526531, oren@eco-fusion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BMI (time frame: 16 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2016.

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