Recruiting

Mobile Phone Intervention

Sponsor:

Eco Fusion

Code:

NCT02621008

Conditions

Diabetes

Hypertension

Pre-diabetes

Overweight

Obese

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Stress Reduction& Healthy living

Study Details

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).

Conditions

Diabetes

Hypertension

Pre-diabetes

Overweight

Obese

Study ID

NCT02621008

Start date

Nov, 2015

Status verified date

Dec, 2015

Completion date

Oct, 2016

Anticipated

Primary completion date

Aug, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • BMI [ Time Frame: 16 weeks ]
  • Glucose level [ Time Frame: 16 weeks ]
  • blood pressure [ Time Frame: 16 weeks ]
  • BMI [ Time Frame: 6 months ]
  • BMI [ Time Frame: 12 months ]
  • glucose level [ Time Frame: 6 months ]
  • glucose level [ Time Frame: 12 months ]
  • blood pressure [ Time Frame: 6 months ]
  • blood pressure [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

oren fuerst, ph.d.

6466526531oren@eco-fusion.com

Locations

Mt Sinai Medical Center

Recruiting

New York, New York, United States, 10029

Contacts

steven kaplan, md

646-652-6531drprostate@aol.com

oren fuerst, phd

6466526531oren@eco-fusion.com

More Information

Sponsor

Eco Fusion

Last update posted

Jan 1, 2016

Last verified

Dec, 2015

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eco Fusion on 2016-01-01.