LIVE SMART: Smartphone Intervention for Weight Control

Study Overview
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Brief Summary
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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.

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: Lifestyle Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Treatment<br>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. | Behavioral: Lifestyle Counseling<br>* Participants receive instructions for making healthy changes to their diet and physical activity habits.<br>|
| Active Comparator: Individual Treatment<br>Participants who are assigned to individual treatment will attend one-on-one sessions with a weight loss counselor every month for 18 months. | Behavioral: Lifestyle Counseling<br>* Participants receive instructions for making healthy changes to their diet and physical activity habits.<br>|
| Experimental: Smartphone Treatment<br>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. | Behavioral: Lifestyle Counseling<br>* Participants receive instructions for making healthy changes to their diet and physical activity habits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss |  | Change from baseline to 18-months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight-related Behaviors | Questionnaire measures of diet, physical activity, and other weight related behaviors such as self-monitoring. | Change from baseline to 18-months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overweight, Obesity, Weight Loss