LIVE SMART: Smartphone Intervention for Weight Control

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01724632
• Other study ID #: 1R01DK095779
• Status: Completed
• Phase: N/A
• First received: November 6, 2012
• Last updated: May 26, 2017
• Start date: November 2012
• Est. completion date: August 2016

Study information

• Verified date: May 2017
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Lifestyle Counseling
Participants receive instructions for making healthy changes to their diet and physical activity habits.

Locations

Country	Name	City	State
United States	Weight Control and Diabetes Resarch Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Engagement with Smartphone Treatment system	Frequency and duration of use of intervention resources made available to the smartphone treatment arm.	Mueasured continuously for the 18-month treatment.
Primary	Weight Loss		Change from baseline to 18-months.
Secondary	Weight-related Behaviors	Questionnaire measures of diet, physical activity, and other weight related behaviors such as self-monitoring.	Change from baseline to 18-months.