NCT02742662

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

April 7, 2016

Last Update Submit

February 13, 2018

Conditions

ObesityOverweightPrediabetesWeight LossLifestyle

Keywords

ObesityOverweightPrediabetesSmartphone applicationTechnologyWeight LossLifestyle Intervention

Outcome Measures

Primary Outcomes (1)

  • Change in body weight in kg

    6 months

Secondary Outcomes (13)

  • Change from baseline blood pressure

    6 months

  • Change from baseline waist circumference

    6 months

  • Change from baseline insulin resistance by homeostasis model assessment (HOMA-IR)

    6 months

  • Change from baseline hemoglobin A1c

    6 months

  • Change from baseline plasma triglycerides

    6 months

  • +8 more secondary outcomes

Study Arms (2)

Smart Technology Group

EXPERIMENTAL

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.

Device: Wearable technology, smartscaleBehavioral: Smartphone applicationsBehavioral: Standard Weight Management Visits

Standard Weight Management Group

OTHER

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.

Behavioral: Standard Weight Management Visits

Interventions

Wearable technology, smartscaleDEVICE
Smart Technology Group
Smartphone applicationsBEHAVIORAL
Smart Technology Group
Standard Weight Management VisitsBEHAVIORAL
Smart Technology GroupStandard Weight Management Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

ObesityOverweightPrediabetic StateWeight Loss

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBody Weight Changes

Intervention Hierarchy (Ancestors)

Electrical Equipment and SuppliesEquipment and Supplies

Study Officials

  • Cherie Vaz, MD Dipl ABOM

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2016

First Posted

April 19, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2017

Study Completion

November 1, 2017

Last Updated

February 15, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)