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

A Self-Administered Mobile Phone-based Holistic Intervention for Promoting Healthy Habits and Weight Loss in People Who Are Overweight or Obese

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02621008
Enrollment
500
Registered
2015-12-03
Start date
2015-11-30
Completion date
2016-10-31
Last updated
2016-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adherence, Diabetes, Hypertension, Obese, Overweight, Pre-diabetes, Weight

Keywords

diabetes, hypertension, obesity, mobile phone, stress, healthy living, pre-diabetes

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.

Interventions

OTHERStress 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.

Sponsors

Eco Fusion
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
BMI16 weeks
Glucose level16 weeks
blood pressure16 weeks
glucose level6 months

Secondary

MeasureTime frameDescription
Mind wandering index16 weekstendency and frequency of mind wandering
Quality of Life questionnaire16 weeks
stress mindset scale16 weeks
Burnout measure16 weeks
Burnout Measure6 months
Perceived dietary adherence questionnaire16 weeks

Countries

United States

Contacts

Primary Contactoren fuerst, ph.d.
oren@eco-fusion.com6466526531

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026