LIVE SMART: Smartphone Intervention for Weight Control

This study is currently recruiting participants.
Verified April 2014 by The Miriam Hospital
Sponsor:
Information provided by (Responsible Party):
John Graham Thomas, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01724632
First received: November 6, 2012
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to compare three methods of delivering behavioral weight loss treatment.Participants are randomly assigned to one of three 18-month weight loss treatments (group, individual, or smartphone treatment). Participants who are assigned to group treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6 months, and then monthly for the final 6 months. Participants who are assigned to individual treatment will attend one-on-one sessions with a weight loss counselor every month for 18 months. Participants who are assigned to smartphone treatment will use a smartphone to learn and practice weight loss skills. They will also attend one-on-one sessions with a weight loss counselor every month for 18 months. Assessment visits are conducted at baseline, 6, 12, and 18 months.


Condition Intervention
Overweight
Obesity
Behavioral: Lifestyle Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: Change from baseline to 18-months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight-related Behaviors [ Time Frame: Change from baseline to 18-months. ] [ Designated as safety issue: No ]
    Questionnaire measures of diet, physical activity, and other weight related behaviors such as self-monitoring.


Other Outcome Measures:
  • Engagement with Smartphone Treatment system [ Time Frame: Mueasured continuously for the 18-month treatment. ] [ Designated as safety issue: No ]
    Frequency and duration of use of intervention resources made available to the smartphone treatment arm.


Estimated Enrollment: 250
Study Start Date: November 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group Treatment
Participants who are assigned to group treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6 months, and then monthly for the final 6 months. Participants will be weighed individually at the start of each group meeting.
Behavioral: Lifestyle Counseling
Participants receive instructions for making healthy changes to their diet and physical activity habits.
Active Comparator: Individual Treatment
Participants who are assigned to individual treatment will attend one-on-one sessions with a weight loss counselor every month for 18 months.
Behavioral: Lifestyle Counseling
Participants receive instructions for making healthy changes to their diet and physical activity habits.
Experimental: Smartphone Treatment
Participants who are assigned to smartphone treatment will use a smartphone to learn and practice weight loss skills. They will also attend one-on-one sessions with a weight loss counselor every month for 18 months.
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:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index (kg/m2) of 25-45.
  • English language fluency
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724632

Contacts
Contact: Graham Thomas, PhD (401) 793-8981 jthomas4@lifespan.org

Locations
United States, Rhode Island
Weight Control and Diabetes Resarch Center Recruiting
Providence, Rhode Island, United States, 02903
Contact: Graham Thomas, PhD    401-793-8154    jthomas4@lifespan.org   
Principal Investigator: Grahamq Thomas, PhD         
Sub-Investigator: Rena R Wing, PhD         
Sub-Investigator: Dale Bond, PhD         
Sponsors and Collaborators
The Miriam Hospital
  More Information

No publications provided

Responsible Party: John Graham Thomas, Assistant Professor (Research), The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01724632     History of Changes
Other Study ID Numbers: 1R01DK095779
Study First Received: November 6, 2012
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
Overweight
Obesity
Weight Loss

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

ClinicalTrials.gov processed this record on April 16, 2014