- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
New York
-
New York, New York, 미국, 10029
- 모병
- Mt Sinai Medical Center
-
연락하다:
- steven kaplan, md
- 전화번호: 646-652-6531
- 이메일: drprostate@aol.com
-
연락하다:
- oren fuerst, phd
- 전화번호: 6466526531
- 이메일: oren@eco-fusion.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
혈압
기간: 6 개월
|
6 개월
|
혈압
기간: 16주
|
16주
|
BMI
기간: 16주
|
16주
|
Glucose level
기간: 16 weeks
|
16 weeks
|
BMI
기간: 6 개월
|
6 개월
|
BMI
기간: 12 개월
|
12 개월
|
glucose level
기간: 6 months
|
6 months
|
glucose level
기간: 12 months
|
12 months
|
혈압
기간: 12 개월
|
12 개월
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Quality of Life questionnaire
기간: 16 weeks
|
16 weeks
|
|
Quality of Life questionnaire
기간: 6 months
|
6 months
|
|
삶의 질 설문지
기간: 12 개월
|
12 개월
|
|
Burnout measure
기간: 16 weeks
|
16 weeks
|
|
Burnout Measure
기간: 6 months
|
6 months
|
|
Burnout measure
기간: 12 months
|
12 months
|
|
Perceived dietary adherence questionnaire
기간: 16 weeks
|
16 weeks
|
|
Perceived dietary adherence questionnaire
기간: 6 months
|
6 months
|
|
Perceived dietary adherence questionnaire
기간: 12 months
|
12 months
|
|
Mind wandering index
기간: 16 weeks
|
tendency and frequency of mind wandering
|
16 weeks
|
Mind wandering index
기간: 6 months
|
6 months
|
|
Mind wandering index
기간: 1 year
|
1 year
|
|
stress mindset scale
기간: 16 weeks
|
16 weeks
|
|
stress mindset scale
기간: 6 months
|
6 months
|
|
stress mindset scale
기간: 1 year
|
1 year
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Stress Reduction& Healthy living에 대한 임상 시험
-
Weill Medical College of Cornell UniversityDoris Duke Charitable Foundation아직 모집하지 않음
-
Universidad de GranadaChair in Conscience and Development (UGR); Mind, Brain and Behaviour Research Centre (CIMCYC)완전한