LIVE SMART: Smartphone Intervention for Weight Control

This study is currently recruiting participants. (see Contacts and Locations)
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
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: 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 August 26, 2014