Smart Technology for Weight Loss and Metabolic Health

NCT ID: NCT02742662

Last Updated: 2018-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-11-30

Brief Summary

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The study will evaluate whether a technology-based lifestyle intervention program using primarily a smartphone platform is an acceptable and effective way for treating obesity. The goal of the program is to achieve weight loss and enhance the health of overweight or obese subjects by improving their diet and activity via smartphone applications as compared with conventional in-person weight management programs.

Detailed Description

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Conditions

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Obesity Overweight Prediabetes Weight Loss Lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Smart Technology Group

The Smart Technology Group will receive a technology-based lifestyle intervention program which uses wearable technology, smartscales and smartphone applications to track and deliver feedback on caloric expenditure, physical activity, caloric intake and body weight. Participants will receive information through smartphone applications on strategies to make changes to their diet, physical activity, and weight-related behaviors along with standard 3 monthly in-person weight management visits.

Group Type EXPERIMENTAL

Wearable technology, smartscale

Intervention Type DEVICE

Smartphone applications

Intervention Type BEHAVIORAL

Standard Weight Management Visits

Intervention Type BEHAVIORAL

Standard Weight Management Group

The Standard Weight Management Group will receive 3 monthly in-person weight management visits during which they will receive standard of care lifestyle recommendations in accordance with the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guideline.

Group Type OTHER

Standard Weight Management Visits

Intervention Type BEHAVIORAL

Interventions

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Wearable technology, smartscale

Intervention Type DEVICE

Smartphone applications

Intervention Type BEHAVIORAL

Standard Weight Management Visits

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Overweight or obese BMI 25-42 kg/m2
* Employed in sedentary occupations
* Own a personal smartphone with unlimited data plan or \>4 GigaByte data
* Proficient with use of smartphone applications and technology with current daily usage
* Ability to engage in moderate intensity exercise
* Weight stability for the last 2 months
* Participants must be willing to comply with all study-related procedures

Exclusion Criteria

* Current or planned pregnancy
* Cardiovascular, pulmonary, renal disease, joint disease
* Uncontrolled thyroid disease
* History of eating disorders, psychiatric disease
* History of substance abuse or dependence in the last 1 year
* Diabetes
* Shift work
* Previous weight loss surgery
* Use of weight loss drugs/diet/program in the last 6 weeks
* Inability to increase walking as a form of exercise and to engage in moderate intensity exercise
* Other conditions or medications that affect body weight/appetite/metabolism
* Serious or unstable medical or psychological conditions that would compromise the subject's safety for successful participation
* Incapable of adhering with an intensive lifestyle intervention using technology and smartphone applications
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Obesity Treatment Foundation

UNKNOWN

Sponsor Role collaborator

Temple University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cherie Vaz, MD Dipl ABOM

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

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Temple University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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23217

Identifier Type: -

Identifier Source: org_study_id

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