Hypertension Clinical Trial
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).
Status | Recruiting |
Enrollment | 500 |
Est. completion date | October 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mt Sinai Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Eco Fusion |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | BMI | 16 weeks | No | |
Primary | Glucose level | 16 weeks | No | |
Primary | blood pressure | 16 weeks | No | |
Primary | BMI | 6 months | No | |
Primary | BMI | 12 months | No | |
Primary | glucose level | 6 months | No | |
Primary | glucose level | 12 months | No | |
Primary | blood pressure | 6 months | No | |
Primary | blood pressure | 12 months | No | |
Secondary | Quality of Life questionnaire | 16 weeks | No | |
Secondary | Quality of Life questionnaire | 6 months | No | |
Secondary | Quality of Life questionnaire | 12 months | No | |
Secondary | Burnout measure | 16 weeks | No | |
Secondary | Burnout Measure | 6 months | No | |
Secondary | Burnout measure | 12 months | No | |
Secondary | Perceived dietary adherence questionnaire | 16 weeks | No | |
Secondary | Perceived dietary adherence questionnaire | 6 months | No | |
Secondary | Perceived dietary adherence questionnaire | 12 months | No | |
Secondary | Mind wandering index | tendency and frequency of mind wandering | 16 weeks | No |
Secondary | Mind wandering index | 6 months | No | |
Secondary | Mind wandering index | 1 year | No | |
Secondary | stress mindset scale | 16 weeks | No | |
Secondary | stress mindset scale | 6 months | No | |
Secondary | stress mindset scale | 1 year | No |
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