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Clinical Trials/NCT01855932
NCT01855932
Completed
Not Applicable

Enlighten: An Adaptive Technology Weight Loss Intervention

Northwestern University1 site in 1 country10 target enrollmentMay 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Northwestern University
Enrollment
10
Locations
1
Primary Endpoint
Change in Anthropometric Measures
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The Enlighten study is an 8-week trial investigating the response to use of a smartphone diet and activity application. Participants are enrolled as part of a worksite intervention, and will receive the LoseIt! weight loss smartphone application, which requires participants to self-monitor dietary intake and physical activity, a component shown to effectively produce weight loss. The application will be programmed to deliver dietary intake recommendations during the first three weeks of the intervention. At the 3 week time point, self-monitoring adherence via the smartphone application will be assessed and those who are not responding will receive 4 weekly telephone coaching sessions. Those individuals who respond at the end of 3 weeks will be encouraged to continue self-monitoring on the application. All participants will also receive regular text messages throughout the trial. The importance of the proposed research lies in the objective to reconfigure weight loss treatment so as to achieve the intended outcome more efficiently and in a manner that allows greater reach.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
September 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bonnie Spring

Principal Investigator

Northwestern University

Eligibility Criteria

Inclusion Criteria

  • BMI greater than 25-39.9 kg/m2
  • Weigh no more than 300 pounds.
  • Weight stable (no loss or gain \>25 lbs for the past 6 months)
  • Not enrolled in any formal weight loss program
  • Not currently taking anti-obesity medications
  • Interested in losing weight
  • Own an Android Smartphone or iPhone, be willing to install the Lose It! Application, and agree to join the Enlighten group which will allow study staff to view participant data using a private coaching interface.

Exclusion Criteria

  • Unstable medical conditions (uncontrolled hypertension, diabetes, unstable angina pectoris, myocardial infarction, transient ischemic attack, cancer undergoing active treatment, or cerebrovascular accident within the past six months)
  • History of diabetes requiring insulin supplementation
  • Crohn's Disease
  • Diagnosis of obstructive sleep apnea requiring intervention (i.e. CPAP)
  • Require use of an assistive device for mobility (e.g., wheelchair, walker, cane)
  • BMI greater than or equal to 40, weight greater than or equal to 300 pounds
  • Hospitalization for a psychiatric disorder within the past 5 years
  • Those at risk for adverse cardiovascular (CVD) events with moderate intensity activity
  • Those who cannot read the study questionnaires will be excluded
  • Those currently taking weight loss medication or committed to following an incompatible dietary regimen.

Outcomes

Primary Outcomes

Change in Anthropometric Measures

Time Frame: Baseline, 8 Weeks

Weight, Waist Circumference, Blood Pressure

Self-Monitoring Adherence over Time

Time Frame: Baseline, 8 weeks

Diet,Activity \& Weight Self-Monitoring

Secondary Outcomes

  • Demographics(Baseline)
  • Call Session Adherence(8 weeks)

Study Sites (1)

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