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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-01624 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 10404 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| R01DK124114 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This phase III trial compares telephone delivered Acceptance and Commitment Therapy to standard behavioral therapy for improving weight loss in overweight or obese participants. Acceptance and Commitment Therapy focuses on increasing willingness to experience physical cravings, emotions, and thoughts while making values-guided committed behavior changes. Acceptance and Commitment Therapy may work better at improving weight loss compared to standard behavioral therapy.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive ACT telephone coaching over the course of 12 months, calls 1-16 weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration, while calls 2-25 are each 15-20 minutes in duration.
ARM II: Participants receive SBT telephone coaching over the course of 12 months, calls 1-16 weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration, while calls 2-25 are each 15-20 minutes in duration.
Participants are followed up at 6, 12, and 24 months after randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (ACT) | Experimental | Participants receive ACT telephone coaching over the course of 12 months, calls 1-16 weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration, while calls 2-25 are each 15-20 minutes in duration. |
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| Arm II (SBT) | Active Comparator | Participants receive SBT telephone coaching over the course of 12 months, calls 1-16 weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration, while calls 2-25 are each 15-20 minutes in duration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey Administration | Other | Ancillary studies |
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| Measure | Description | Time Frame |
|---|---|---|
| 10% or more weight loss | Will be measured remotely by cellular-enabled scales. Will compare the two telephone interventions, using logistic regression. | At 12 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Percent weight change | Will be measured remotely by cellular-enabled scales. | At 6, 12, and 24-months post randomization |
| Dietary intake | Will be measured with the Fitbit smartphone app food logging feature. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan B Bricker | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 26, 2021 | Aug 15, 2024 | ICF_000.pdf |
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| Telephone-Based Intervention |
| Behavioral |
Receive ACT telephone coaching |
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| Telephone-Based Intervention | Behavioral | Receive SBT telephone coaching |
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| At 6, 12, and 24-months post randomization |
| Physical activity | Will be measured with the Fitbit Inspire mailed to participants. | At 6, 12, and 24-months post randomization |
| Trajectories of weight change | Will compare between the two arms, with time as the independent variable using mixed effects modeling with linear, quadratic, and cubic effects of time. | At 6, 12, and 24-months post randomization |