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
1 other identifier
interventional
500
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Nov 2015
Shorter than P25 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 25, 2015
CompletedFirst Posted
Study publicly available on registry
December 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedJanuary 1, 2016
December 1, 2015
9 months
November 25, 2015
December 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
BMI
16 weeks
Glucose level
16 weeks
blood pressure
16 weeks
BMI
6 months
BMI
12 months
glucose level
6 months
glucose level
12 months
blood pressure
6 months
blood pressure
12 months
Secondary Outcomes (15)
Quality of Life questionnaire
16 weeks
Quality of Life questionnaire
6 months
Quality of Life questionnaire
12 months
Burnout measure
16 weeks
Burnout Measure
6 months
- +10 more secondary outcomes
Study Arms (1)
Stress Reduction& Healthy living
EXPERIMENTALUtilizing 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eco Fusionlead
Study Sites (1)
Mt Sinai Medical Center
New York, New York, 10029, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2015
First Posted
December 3, 2015
Study Start
November 1, 2015
Primary Completion
August 1, 2016
Study Completion
October 1, 2016
Last Updated
January 1, 2016
Record last verified: 2015-12