Trials / Completed
CompletedNCT03738540
Pilot Trial of a Telephone Weight Loss, Nutrition, Exercise Study
Pilot Randomized Trial of a Telephone Weight Loss, Nutrition, Exercise Study (WeLNES)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 105 (actual)
- Sponsor
- Fred Hutchinson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Many behavioral weight loss interventions have been developed, but still have significant limitations in terms of achieving clinically significant, sustained weight loss. A recent study incorporating Acceptance and Commitment Therapy (ACT) in a randomized clinical trial resulted in participants who attained significantly greater 12-month weight loss in the ACT arm than those assigned to standard behavioral treatment, suggesting that ACT may have the potential to improve behavioral weight loss outcomes. The investigators have developed a novel telephone-delivered version of the ACT behavioral weight loss intervention, based on proven success using ACT telephone counseling intervention for smoking cessation.
Detailed description
There is consistent evidence from observational studies that higher amounts of body fat are associated with increased risks of cancer. Many behavioral weight loss interventions have been developed, but still have significant limitations in terms of achieving clinically significant, sustained weight loss. A recent study incorporating Acceptance and Commitment Therapy (ACT) in a randomized clinical trial resulted in participants who attained significantly greater 12-month weight loss in the ACT arm than those assigned to standard behavioral treatment, suggesting that ACT may have the potential to improve behavioral weight loss outcomes. However, this study required in-person clinic visits with treatment groups, which limits its potential reach and disseminability. The investigators have developed a novel telephone-delivered version of the ACT behavioral weight loss intervention, based on our proven success using ACT telephone counseling intervention for smoking cessation. There will be a two-arm pilot randomized trial (N = 100), comparing the ACT telephone intervention to a standard behavioral treatment (SBT) telephone control. The pilot RCT will yield engagement, receptivity, and preliminary weight loss results that will provide critical and timely weight loss intervention data.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | TALK study group | Telephone Delivered Intervention |
| BEHAVIORAL | TALK control group | Telephone Delivered Intervention |
Timeline
- Start date
- 2018-08-29
- Primary completion
- 2020-06-30
- Completion
- 2020-12-31
- First posted
- 2018-11-13
- Last updated
- 2021-01-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03738540. Inclusion in this directory is not an endorsement.