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Enlighten: An Adaptive Technology Weight Loss Intervention

Primary Purpose

Obesity, Weight Loss

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Technology Supported

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.
Female participants may not be pregnant, trying to get pregnant, or lactating.
Bulimia Nervosa
Binge Eating Disorder
Active Suicidal Ideation
those on medications known to cause weight gain (e.g., prednisone)
current substance abuse or dependence besides nicotine dependence
low motivation to change that would interfere with program adherence

Sites / Locations

Northwestern University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Technology Supported

Arm Description

Outcomes

Primary Outcome Measures

Change in Anthropometric Measures

Weight, Waist Circumference, Blood Pressure

Self-Monitoring Adherence over Time

Diet,Activity & Weight Self-Monitoring

Secondary Outcome Measures

Demographics

Call Session Adherence

Full Information

NCT ID

NCT01855932

First Posted

May 10, 2013

Last Updated

September 20, 2013

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT01855932

Brief Title

Enlighten: An Adaptive Technology Weight Loss Intervention

Official Title

Enlighten: An Adaptive Technology Weight Loss Intervention

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Weight Loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Technology Supported

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Technology Supported

Intervention Description

All participants will complete 8 weeks of recording of dietary intake, weight, and physical activity on a smartphone application. Time-stamped data from the smartphone will upload automatically to the application server, where it will be visible to the lifestyle coach. The participant's real-time diet, activity and weight data relative to their goals will be visually depicted on the participant's smartphone. The coach will monitor participant adherence and send supportive text messages. Response to the application will be assessed 3 weeks after enrollment into the study; measured by number of food items recorded between weeks 1-3 of the intervention; an indicator of use and adherence. Based on adherence, some participants may receive 4 telephone coaching sessions between weeks 5 and 8. Telephone coaching sessions will include feedback on self-monitoring and goal attainment, problem solving, and motivational interviewing.

Primary Outcome Measure Information:

Title

Change in Anthropometric Measures

Description

Weight, Waist Circumference, Blood Pressure

Time Frame

Baseline, 8 Weeks

Title

Self-Monitoring Adherence over Time

Description

Diet,Activity & Weight Self-Monitoring

Time Frame

Baseline, 8 weeks

Secondary Outcome Measure Information:

Title

Demographics

Time Frame

Baseline

Title

Call Session Adherence

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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. Female participants may not be pregnant, trying to get pregnant, or lactating. Bulimia Nervosa Binge Eating Disorder Active Suicidal Ideation those on medications known to cause weight gain (e.g., prednisone) current substance abuse or dependence besides nicotine dependence low motivation to change that would interfere with program adherence

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bonnie J Spring, PhD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

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