Back to resultsLIVE SMART: Smartphone Intervention for Weight Control
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Overweight, Obesity, Weight Loss
Eligibility 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
Sites / Locations
- Weight Control and Diabetes Resarch Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Group Treatment
Individual Treatment
Smartphone Treatment
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Weight Loss
Secondary Outcome Measures
Weight-related Behaviors
Questionnaire measures of diet, physical activity, and other weight related behaviors such as self-monitoring.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01724632
Brief Title
LIVE SMART: Smartphone Intervention for Weight Control
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Overweight, Obesity, Weight Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
276 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Individual Treatment
Arm Type
Active Comparator
Arm Description
Participants who are assigned to individual treatment will attend one-on-one sessions with a weight loss counselor every month for 18 months.
Arm Title
Smartphone Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Counseling
Intervention Description
Participants receive instructions for making healthy changes to their diet and physical activity habits.
Primary Outcome Measure Information:
Title
Weight Loss
Time Frame
Change from baseline to 18-months.
Secondary Outcome Measure Information:
Title
Weight-related Behaviors
Description
Questionnaire measures of diet, physical activity, and other weight related behaviors such as self-monitoring.
Time Frame
Change from baseline to 18-months.
Other Pre-specified Outcome Measures:
Title
Engagement with Smartphone Treatment system
Description
Frequency and duration of use of intervention resources made available to the smartphone treatment arm.
Time Frame
Mueasured continuously for the 18-month treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Weight Control and Diabetes Resarch Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31556659
Citation
Goldstein SP, Goldstein CM, Bond DS, Raynor HA, Wing RR, Thomas JG. Associations between self-monitoring and weight change in behavioral weight loss interventions. Health Psychol. 2019 Dec;38(12):1128-1136. doi: 10.1037/hea0000800. Epub 2019 Sep 26.
Results Reference
derived
PubMed Identifier
30779333
Citation
Thomas JG, Bond DS, Raynor HA, Papandonatos GD, Wing RR. Comparison of Smartphone-Based Behavioral Obesity Treatment With Gold Standard Group Treatment and Control: A Randomized Trial. Obesity (Silver Spring). 2019 Apr;27(4):572-580. doi: 10.1002/oby.22410. Epub 2019 Feb 19.
Results Reference
derived
PubMed Identifier
25475207
Citation
Bond DS, Thomas JG, O'Leary KC, Lipton RB, Peterlin BL, Roth J, Rathier L, Wing RR. Objectively measured physical activity in obese women with and without migraine. Cephalalgia. 2015 Sep;35(10):886-93. doi: 10.1177/0333102414562970. Epub 2014 Dec 4.
Results Reference
derived
Learn more about this trial
LIVE SMART: Smartphone Intervention for Weight Control
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