- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01241578
Improving Behavioral Weight Loss Via Electronic Handheld Device
April 6, 2015 updated by: John Graham Thomas, The Miriam Hospital
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Weight Control and Diabetes Resarch Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mobile Phone Intervention
Participants receive a behavioral intervention via mobile phone and brief in-person counseling sessions.
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Participants receive instructions for making healthy changes to their diet and physical activity habits.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: Baseline and weekly for 24-weeks.
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Participants' body weight measured in kg.
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Baseline and weekly for 24-weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Graham Thomas, Ph.D., Brown University
- Principal Investigator: Rena R Wing, Ph.D., Brown University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
November 12, 2010
First Submitted That Met QC Criteria
November 15, 2010
First Posted (Estimate)
November 16, 2010
Study Record Updates
Last Update Posted (Estimate)
April 7, 2015
Last Update Submitted That Met QC Criteria
April 6, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TOSNewInvestigator2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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