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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

TypeNameDescription
OTHERRapid weight loss (RWL) program16-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
OTHERGradual weight loss (GWL) program16-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.