LIVE SMART: Smartphone Intervention for Weight Control
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Miriam Hospital
- Enrollment
- 276
- Locations
- 1
- Primary Endpoint
- Weight Loss
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Body Mass Index (kg/m2) of 25-
- •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
Arms & Interventions
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.
Intervention: Lifestyle Counseling (Behavioral)
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.
Intervention: Lifestyle Counseling (Behavioral)
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.
Intervention: Lifestyle Counseling (Behavioral)
Outcomes
Primary Outcomes
Weight Loss
Time Frame: Change from baseline to 18-months.
Secondary Outcomes
- Weight-related Behaviors(Change from baseline to 18-months.)
Investigators
John Graham Thomas
Assistant Professor (Research)
The Miriam Hospital