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.
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.
United States1 site, 1 recruiting
- 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
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.
- Conditions
- Diabetes, Hypertension, Pre-diabetes, Overweight, Obese, Weight
- 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 group | Role | What they receive |
|---|---|---|
| Stress Reduction& Healthy living | Experimental | 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. Receives: Other: Stress Reduction& Healthy living |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Measured: 16 weeks
Glucose level
Measured: 16 weeks
blood pressure
Measured: 16 weeks
BMI
Measured: 6 months
BMI
Measured: 12 months
glucose level
Measured: 6 months
glucose level
Measured: 12 months
blood pressure
Measured: 6 months
blood pressure
Measured: 12 months
Secondary outcomes (15)
Quality of Life questionnaire
Measured: 16 weeks
Quality of Life questionnaire
Measured: 6 months
Quality of Life questionnaire
Measured: 12 months
Burnout measure
Measured: 16 weeks
Burnout Measure
Measured: 6 months
Burnout measure
Measured: 12 months
Perceived dietary adherence questionnaire
Measured: 16 weeks
Perceived dietary adherence questionnaire
Measured: 6 months
Perceived dietary adherence questionnaire
Measured: 12 months
Mind wandering index
tendency and frequency of mind wandering
Measured: 16 weeks
Mind wandering index
Measured: 6 months
Mind wandering index
Measured: 1 year
stress mindset scale
Measured: 16 weeks
stress mindset scale
Measured: 6 months
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.
- First posted3 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionAug 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Eco Fusion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-Administered Mobile Phone-based Holistic Intervention for Promoting Healthy Habits and Weight Loss in People Who Are Overweight or Obese
- ClinicalTrials.gov ID
- NCT02621008
- Acronym / sponsor ID
- 007
- Conditions
- Diabetes, Hypertension, Pre-diabetes, Overweight, Obese, Weight
- Keywords
- diabetes, hypertension, obesity, mobile phone, stress, healthy living, pre-diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Eco FusionIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 3 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stress Reduction& Healthy living | Experimental | Other: Stress Reduction& Healthy livingUtilizing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress Reduction& Healthy livingUtilizing 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 |
Primary outcome
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
15 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.