Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03867981 |
Other study ID # |
1296020 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 6, 2019 |
Est. completion date |
May 1, 2023 |
Study information
Verified date |
April 2022 |
Source |
The Miriam Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to examine whether adding phone coaching to an Internet-based
weight loss program can improve weight loss outcomes at 4 months and 1 year. All individuals
will receive a 4-month, Internet-delivered weight loss program followed by an 8-month
Internet-delivered weight loss maintenance program. Some individuals will also be selected to
receive either 3 weeks or 12 weeks of phone coaching. Assessments of weight, diet, physical
activity, and psychosocial factors will occur at baseline, 4 months, and 1 year.
Description:
All individuals enrolled in this study will receive a 4-month Internet-based weight loss
program followed by an 8-month Internet-based weight loss maintenance program. During the
first 4 months, each week individuals will be asked to view a 10-15-minute multi-media lesson
(one per week). These lessons focus on behavioral principles for changing diet and physical
activity behaviors. Participants are also given weight loss, calorie intake, and physical
activity goals. They are taught how to self-monitor this information and are instructed to
submit it weekly on the study website. Automated, weekly individualized feedback is provided.
Following the 4-month weight loss program participants will receive an 8-month weight loss
maintenance program. During this time, they will be asked to view monthly video lessons which
focus on strategies for successful WL maintenance and instructed to continue to self-monitor
weight, calorie intake, and physical activity minutes on the study website for one week per
month. Automated, monthly feedback is provided.
In addition to the Internet program described above, some individuals enrolled in this study
will be selected to receive phone coaching. Those selected for 'brief' phone coaching will be
asked to complete 3 phone calls with a coach between weeks 5-8 of the study and those
selected to receive 'extended' phone coaching will be asked to complete 12 phone calls with a
coach between weeks 5-16. The first coaching call will be approximately 45 minutes in
duration and all subsequent calls will be approximately 15 minutes in duration. The coach
will assist participants in developing a meal plan, problem solving around current barriers,
and goal setting. Upon completion of all coaching calls participants will have no additional
interaction with the coach, but will remain enrolled in the Internet program.
Assessments will occur at baseline, 4, and 12 months.