Effectiveness of Gradual Versus Rapid Weight Loss (GoLow)

The Hospital of Vestfold

Status: Active, not recruiting

Conditions: Obesity

Treatments: Other: Rapid weight loss (RWL) program; Other: Gradual weight loss (GWL) program

Study type: Interventional

Funder types: Other

Identifiers

NCT03776552

GoLow

Details and patient eligibility

About

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.

Full 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.

Enrollment: 293 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• • Willing and able to give informed consent for participation in the study

  • Living in the eastern part of Norway, mainly Oslo, Buskerud, Vestfold and Akershus
  • Understanding Norwegian language written and spoken easily
  • BMI ≥30.0 kg/m2
  • Stable body weight (<5 kg self-reported weight change) during the last 3 months before inclusion

Exclusion criteria

• • Pregnancy and breast-feeding mothers

  • Suspected non-compliance with regards to visits and/or diet
  • Severe chronic disease (endocrine disease, heart disease, neurological disease, lung disease, disease in the gastrointestinal tract, kidney disease, rheumatism or cancer).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

293 participants in 2 patient groups

Rapid weight loss (RWL) program

Active Comparator group

Description:

16-week rapid weight loss (RWL) program \[8-week LED (\<1000 kcal/day) - followed by an 8-week gradual increase in energy intake (4 weeks \<1300 kcal/day and 4 weeks \<1500 kcal/day)\] followed by a 36-weight loss maintenance program.

Treatment:

Other: Rapid weight loss (RWL) program

Gradual weight loss (GWL) program

Active Comparator group

Description:

16-week GWL-program (estimated total energy expenditure minus 800-1000 kcal/day) followed by a 36-weight loss maintenance program.

Treatment:

Other: Gradual weight loss (GWL) program