Clinical trial NCT03776552: Effectiveness of Gradual Versus Rapid Weight Loss
Official title: 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).
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: The Hospital of Vestfold
Sponsor class: OTHER
Collaborators: name: Roede AS
First posted: 2018-12-14
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in body weight from baseline to 12 months
timeFrame: Baseline to 1-year
Secondary outcomes:
measure: Changes in anthropometric measures
timeFrame: 4-month and 1-year
measure: Changes in body composition 1
timeFrame: 4-month and 1-year
measure: Changes in body composition 2
timeFrame: 4-month and 1-year
measure: Changes in lipids
timeFrame: 4-month and 1-year
measure: Changes in blood pressure
timeFrame: 4-month and 1-year
measure: Changes in glucose parameters
timeFrame: 4-month and 1-year
measure: Changes in CRP
timeFrame: 4-month and 1-year
measure: Changes in Health Related Quality of Life 1
timeFrame: 4-month and 1-year
measure: Changes in Health Related Quality of Life 2
timeFrame: 4-month and 1-year
measure: Changes in Health Related Quality of Life 3
timeFrame: 4-month and 1-year
measure: Changes in symptoms of depression and anxiety
timeFrame: 4-month and 1-year
measure: Changes in eating behavior
timeFrame: 4-month and 1-year
measure: Change in weight from baseline to 4 months
timeFrame: 4-month
measure: Proportions of participants with a TBWL of ≥ 5%, ≥10% and ≥15% at 52-week
timeFrame: 1-year
Other outcomes:
Locations:
city: Tønsberg
country: Norway
facility: Vestfold Hospital Trust
Study officials:
affiliation: The Hospital of Vestfold
name: Jøran Hjelmesæth, Professor
role: PRINCIPAL_INVESTIGATOR
References: