Improving Behavioral Weight Loss Via Electronic Handheld Device
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Behavior Therapy, Lifestyle, Technology, Cellular Phone
Eligibility Criteria
Inclusion Criteria:
- Body Mass Index (kg/m2) of 30-45.
- English language fluency
- Basic familiarity with cell phone technology
- Ability to read at a 6th grade level
- Availability to attend weekly treatment sessions in Providence, RI
Exclusion Criteria:
- Any heart condition that limits ability to participate in physical activity
- Chest Pain
- Any cognitive of physical limitation that would preclude use of a smartphone
- Serious mental illness
- Historical or current eating disorder
- Previous or planned bariatric surgery
- Use of weight loss medication
- Recent pregnancy or a plan to become pregnant in the next 6 months
- Participation in a study at the Weight Control and Diabetes Research Center within the last two years
- A weight loss of greater than 5% body weight in the last 6 months
Sites / Locations
- Weight Control and Diabetes Resarch Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mobile Phone Intervention
Arm Description
Participants receive a behavioral intervention via mobile phone and brief in-person counseling sessions.
Outcomes
Primary Outcome Measures
Weight
Participants' body weight measured in kg.
Secondary Outcome Measures
Full Information
NCT ID
NCT01241578
First Posted
November 12, 2010
Last Updated
April 6, 2015
Sponsor
The Miriam Hospital
Collaborators
The Obesity Society
1. Study Identification
Unique Protocol Identification Number
NCT01241578
Brief Title
Improving Behavioral Weight Loss Via Electronic Handheld Device
Official Title
Improving Behavioral Weight Loss Via Electronic Handheld Device
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital
Collaborators
The Obesity Society
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Standard behavioral treatment (SBT) for obesity is often effective, but weight losses are highly variable, and patients sometimes fail to achieve a "successful" weight loss of 5-10% of their starting weight. It has been suggested that the "one size fits all" approach of SBT may be responsible for many treatment failures because the intervention is not sufficiently tailored to address the unique needs of each patient. Moreover, treatment is delivered in the clinic, not in the settings and the times when it is needed most. The primary aim of the proposed research is to develop and pilot test a behavioral weight loss intervention that combines in-person sessions with treatment delivered via an electronic handheld device to provide highly individualized weight loss treatment in patients' natural environment. In a critical departure from previous research using cell phone technology, the portion of intervention that is delivered via handheld device will be of equal sophistication and importance to the portion of the intervention that is delivered in face-to-face treatment sessions. The proposed study seeks to determine the feasibility and preliminary efficacy of an individually tailored behavioral weight loss program that integrates clinic-based care and smartphone technology.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Behavior Therapy, Lifestyle, Technology, Cellular Phone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile Phone Intervention
Arm Type
Experimental
Arm Description
Participants receive a behavioral intervention via mobile phone and brief in-person counseling sessions.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Counseling
Intervention Description
Participants receive instructions for making healthy changes to their diet and physical activity habits.
Primary Outcome Measure Information:
Title
Weight
Description
Participants' body weight measured in kg.
Time Frame
Baseline and weekly for 24-weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Body Mass Index (kg/m2) of 30-45.
English language fluency
Basic familiarity with cell phone technology
Ability to read at a 6th grade level
Availability to attend weekly treatment sessions in Providence, RI
Exclusion Criteria:
Any heart condition that limits ability to participate in physical activity
Chest Pain
Any cognitive of physical limitation that would preclude use of a smartphone
Serious mental illness
Historical or current eating disorder
Previous or planned bariatric surgery
Use of weight loss medication
Recent pregnancy or a plan to become pregnant in the next 6 months
Participation in a study at the Weight Control and Diabetes Research Center within the last two years
A weight loss of greater than 5% body weight in the last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham Thomas, Ph.D.
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rena R Wing, Ph.D.
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weight Control and Diabetes Resarch Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
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Improving Behavioral Weight Loss Via Electronic Handheld Device
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