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Improving Behavioral Weight Loss Via Electronic Handheld Device

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ClinicalTrials.gov Identifier: NCT01241578
Recruitment Status : Completed
First Posted : November 16, 2010
Last Update Posted : April 7, 2015
The Obesity Society
Information provided by (Responsible Party):
John Graham Thomas, The Miriam Hospital

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.

Condition or disease Intervention/treatment
Obesity Behavioral: Lifestyle Counseling

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Behavioral Weight Loss Via Electronic Handheld Device
Study Start Date : February 2010
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Mobile Phone Intervention
Participants receive a behavioral intervention via mobile phone and brief in-person counseling sessions.
Behavioral: Lifestyle Counseling
Participants receive instructions for making healthy changes to their diet and physical activity habits.

Primary Outcome Measures :
  1. Weight [ Time Frame: Baseline and weekly for 24-weeks. ]
    Participants' body weight measured in kg.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241578

United States, Rhode Island
Weight Control and Diabetes Resarch Center
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
The Obesity Society
Principal Investigator: Graham Thomas, Ph.D. Brown University
Principal Investigator: Rena R Wing, Ph.D. Brown University

Responsible Party: John Graham Thomas, Assistant Professor (Research), The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01241578     History of Changes
Other Study ID Numbers: TOSNewInvestigator2009
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015

Keywords provided by John Graham Thomas, The Miriam Hospital:
Behavior Therapy
Cellular Phone

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms