Study Results
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View full resultsBasic Information
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COMPLETED
NA
452 participants
INTERVENTIONAL
2019-03-06
2023-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Internet weight loss + possibility of brief phone coaching
Participants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. Some participants in this group will also be selected to receive a brief period (i.e., once/week for 3 weeks) of phone coaching starting at week 5. The first coaching call will be approximately 45 minutes in duration and remaining calls with be 10-15 minutes. Coaches will problem solve with participants and help them develop an individualized meal plan.
Internet-based weight loss program
12-month, Internet-based weight loss/maintenance program.
Brief phone coaching
Some individuals will receive 3 weeks of phone coaching. Coaching calls will occur 1x/week, starting at week 5. Once coaching calls are completed, the participant will not have any other contact with their coach.
Internet weight loss + possibility of extended phone coaching
Participants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. Some participants in this group will also be selected to receive an extended period (i.e., once/week for 12 weeks) of phone coaching starting at week 5. The first coaching call will be approximately 45 minutes in duration and remaining calls with be 10-15 minutes. Coaches will problem solve with participants and help them develop an individualized meal plan.
Internet-based weight loss program
12-month, Internet-based weight loss/maintenance program.
Extended phone coaching
Some individuals will receive 12 weeks of phone coaching. Coaching calls will occur 1x/week, starting at week 5. Once coaching calls are completed, the participant will not have any other contact with their coach.
Internet weight loss only
Participants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. No participants in this group will receive any phone coaching.
Internet-based weight loss program
12-month, Internet-based weight loss/maintenance program.
Interventions
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Internet-based weight loss program
12-month, Internet-based weight loss/maintenance program.
Brief phone coaching
Some individuals will receive 3 weeks of phone coaching. Coaching calls will occur 1x/week, starting at week 5. Once coaching calls are completed, the participant will not have any other contact with their coach.
Extended phone coaching
Some individuals will receive 12 weeks of phone coaching. Coaching calls will occur 1x/week, starting at week 5. Once coaching calls are completed, the participant will not have any other contact with their coach.
Eligibility Criteria
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Inclusion Criteria
* BMI: 25-45 kg/m2
* Regular internet access
Exclusion Criteria
* Current enrollment in a commercial weight loss program or other weight loss research study
* Currently taking weight loss medications
* Previously had bariatric surgery
* Inability to walk 2 blocks without stopping
* Any medical condition for which weight loss, dietary restriction, or physical activity is contraindicated
18 Years
70 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
The Miriam Hospital
OTHER
Responsible Party
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Principal Investigators
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Jessica L Unick, PhD
Role: PRINCIPAL_INVESTIGATOR
The Miriam Hospital's Weight Control and Diabetes Research Center
Locations
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The Miriam Hospital's Weight Control and Diabetes Research Center
Providence, Rhode Island, United States
Countries
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References
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Unick JL, Pellegrini CA, Dunsiger SI, Demos KE, Thomas JG, Bond DS, Lee RH, Webster J, Wing RR. An Adaptive Telephone Coaching Intervention for Patients in an Online Weight Loss Program: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2414587. doi: 10.1001/jamanetworkopen.2024.14587.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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1296020
Identifier Type: -
Identifier Source: org_study_id
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