Trials / Active Not Recruiting
Active Not RecruitingNCT03776552
Effectiveness of Gradual Versus Rapid Weight Loss
Comparative Effectiveness of a Gradual Weight Loss Program and a Rapid Weight Loss Program (Including a Low Energy Diet) on 1-year Weight Loss in Subjects With Obesity - A Randomized, Parallel-group, Superiority Trial. (The GoLow Study).
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 293 (actual)
- Sponsor
- The Hospital of Vestfold · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This randomized controlled trial aims to compare the 1-year effectiveness of an initial rapid weight loss (RWL) program and a gradual weight loss (GWL) program.
Detailed description
A total of at least 286 participants will be randomized to either a 16-week rapid weight loss (RWL) program; \[an 8-week low-energy-diet (\<1000 kcal/day) - followed by an 8-week gradual increase in energy intake (4 weeks \<1300 kcal/day and 4 weeks \<1500 kcal/day)\], or a 16-week gradual weight loss (GWL) program (controls); \[estimated total energy expenditure minus 800-1000 kcal/day\]. Thereafter, all participants (both groups) will undergo a 36-week comprehensive weight maintenance program.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Rapid weight loss (RWL) program | 16-week rapid weight loss (RWL) program (8-week low energy diet (LED) followed by 8-week gradual increased energy intake) and a subsequent 36-week weight-maintenance follow-up |
| OTHER | Gradual weight loss (GWL) program | 16-week gradual weight loss (GWL) program (moderate calorie restriction) and a subsequent 36-week weight-maintenance follow-up |
Timeline
- Start date
- 2019-04-11
- Primary completion
- 2021-09-16
- Completion
- 2028-12-31
- First posted
- 2018-12-14
- Last updated
- 2025-06-11
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT03776552. Inclusion in this directory is not an endorsement.