- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02621008
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
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
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New York
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New York, New York, Forenede Stater, 10029
- Rekruttering
- Mt Sinai Medical Center
-
Kontakt:
- steven kaplan, md
- Telefonnummer: 646-652-6531
- E-mail: drprostate@aol.com
-
Kontakt:
- oren fuerst, phd
- Telefonnummer: 6466526531
- E-mail: oren@eco-fusion.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
blodtryk
Tidsramme: 6 måneder
|
6 måneder
|
|
blodtryk
Tidsramme: 16 uger
|
16 uger
|
|
BMI
Tidsramme: 16 uger
|
16 uger
|
|
Glucose level
Tidsramme: 16 weeks
|
16 weeks
|
|
BMI
Tidsramme: 6 måneder
|
6 måneder
|
|
BMI
Tidsramme: 12 måneder
|
12 måneder
|
|
glucose level
Tidsramme: 6 months
|
6 months
|
|
glucose level
Tidsramme: 12 months
|
12 months
|
|
blodtryk
Tidsramme: 12 måneder
|
12 måneder
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of Life questionnaire
Tidsramme: 16 weeks
|
16 weeks
|
|
|
Quality of Life questionnaire
Tidsramme: 6 months
|
6 months
|
|
|
Spørgeskema om livskvalitet
Tidsramme: 12 måneder
|
12 måneder
|
|
|
Burnout measure
Tidsramme: 16 weeks
|
16 weeks
|
|
|
Burnout Measure
Tidsramme: 6 months
|
6 months
|
|
|
Burnout measure
Tidsramme: 12 months
|
12 months
|
|
|
Perceived dietary adherence questionnaire
Tidsramme: 16 weeks
|
16 weeks
|
|
|
Perceived dietary adherence questionnaire
Tidsramme: 6 months
|
6 months
|
|
|
Perceived dietary adherence questionnaire
Tidsramme: 12 months
|
12 months
|
|
|
Mind wandering index
Tidsramme: 16 weeks
|
tendency and frequency of mind wandering
|
16 weeks
|
|
Mind wandering index
Tidsramme: 6 months
|
6 months
|
|
|
Mind wandering index
Tidsramme: 1 year
|
1 year
|
|
|
stress mindset scale
Tidsramme: 16 weeks
|
16 weeks
|
|
|
stress mindset scale
Tidsramme: 6 months
|
6 months
|
|
|
stress mindset scale
Tidsramme: 1 year
|
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 007
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