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Improving Behavioral Weight Loss Via Electronic Handheld Device

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
The Obesity Society
Information provided by (Responsible Party):
John Graham Thomas, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01241578
First received: November 12, 2010
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

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 Intervention
Obesity
Behavioral: Lifestyle Counseling

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Behavioral Weight Loss Via Electronic Handheld Device

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Weight [ Time Frame: Baseline and weekly for 24-weeks. ] [ Designated as safety issue: No ]
    Participants' body weight measured in kg.


Estimated Enrollment: 20
Study Start Date: February 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241578

Locations
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
Investigators
Principal Investigator: Graham Thomas, Ph.D. Brown University
Principal Investigator: Rena R Wing, Ph.D. Brown University
  More Information

No publications provided

Responsible Party: John Graham Thomas, Assistant Professor (Research), The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01241578     History of Changes
Other Study ID Numbers: TOSNewInvestigator2009
Study First Received: November 12, 2010
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
Obesity
Behavior Therapy
Lifestyle
Technology
Cellular Phone

Additional relevant MeSH terms:
Obesity
Weight Loss
Body Weight
Body Weight Changes
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014