Obesity, Overweight
Conditions
Keywords
Overweight, Obesity, Weight Loss
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.
Interventions
BEHAVIORALLifestyle Counseling
Participants receive instructions for making healthy changes to their diet and physical activity habits.
Sponsors
The Miriam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight Loss | Change from baseline to 18-months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight-related Behaviors | Change from baseline to 18-months. | Questionnaire measures of diet, physical activity, and other weight related behaviors such as self-monitoring. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Engagement with Smartphone Treatment system | Mueasured continuously for the 18-month treatment. | Frequency and duration of use of intervention resources made available to the smartphone treatment arm. |
Countries
United States
Outcome results
None listed