Clinical trial NCT01724632: LIVE SMART: Smartphone Intervention for Weight Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Overweight
Obesity
Weight Loss
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2012-11-12
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Weight Loss
timeFrame: Change from baseline to 18-months.
Secondary outcomes:
measure: Weight-related Behaviors
timeFrame: Change from baseline to 18-months.
Other outcomes:
measure: Engagement with Smartphone Treatment system
timeFrame: Mueasured continuously for the 18-month treatment.
Locations:
city: Providence
country: United States
facility: Weight Control and Diabetes Resarch Center
state: Rhode Island
Study officials:
References:
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.
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.
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.