Improving Behavioral Weight Loss Via Electronic Handheld Device

NCT01241578 | Completed

• 1 other identifier: TOSNewInvestigator2009
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Behavior Therapy; Lifestyle; Technology; Cellular Phone

Outcome Measures

Primary Outcomes (1)

• Weight

  Participants' body weight measured in kg.

  Baseline and weekly for 24-weeks.

Study Arms (1)

Mobile Phone Intervention

EXPERIMENTAL

Participants receive a behavioral intervention via mobile phone and brief in-person counseling sessions.

Behavioral: Lifestyle Counseling

Interventions

Lifestyle Counseling BEHAVIORAL

Participants receive instructions for making healthy changes to their diet and physical activity habits.

Mobile Phone Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead
• The Obesity Society: collaborator

Study Sites (1)

Weight Control and Diabetes Resarch Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Graham Thomas, Ph.D.

  Brown University

  PRINCIPAL INVESTIGATOR

• Rena R Wing, Ph.D.

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Research)

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: November 16, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

US (1)