LIVE SMART: Smartphone Intervention for Weight Control

Not Applicable

Completed

• Conditions: Obesity; Overweight
• Interventions: Behavioral: Lifestyle Counseling

• Registration Number: NCT01724632
• Lead Sponsor: The Miriam Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-06
• Study First Submitted QC: 2012-11-07
• Study First Posted: 2012-11-12
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-26
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Treatment	Lifestyle Counseling	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.
Smartphone Treatment	Lifestyle Counseling	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.
Individual Treatment	Lifestyle Counseling	Participants who are assigned to individual treatment will attend one-on-one sessions with a weight loss counselor every month for 18 months.

Primary Outcome Measures

Name	Time	Method
Weight Loss	Change from baseline to 18-months.

Secondary Outcome Measures

Name	Time	Method
Weight-related Behaviors	Change from baseline to 18-months.	Questionnaire measures of diet, physical activity, and other weight related behaviors such as self-monitoring.

Trial Locations

Locations (1)

Weight Control and Diabetes Resarch Center; 🇺🇸 Providence, Rhode Island, United States