ObesityGoLowNCT03776552
Effectiveness of Gradual Versus Rapid Weight Loss
A study testing Rapid weight loss (RWL) program and Gradual weight loss (GWL) program in people with Obesity, run by The Hospital of Vestfold at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Rapid weight loss (RWL) program and Gradual weight loss (GWL) program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 1 siteNorway
- Study dates
- 11 Apr 2019to 16 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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 locations and contacts
1 site in 1 country.
About this study
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).
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.
Read the 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
- Obesity
- Being tested
- Rapid weight loss (RWL) program, Gradual weight loss (GWL) program
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid weight loss (RWL) programOther
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
Gradual weight loss (GWL) programOther
16-week gradual weight loss (GWL) program (moderate calorie restriction) and a subsequent 36-week weight-maintenance follow-up
| Study group | Role | What they receive |
|---|---|---|
| Rapid weight loss (RWL) program | Active comparator | 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. Receives: Other: Rapid weight loss (RWL) program |
| Gradual weight loss (GWL) program | Active comparator | 16-week GWL-program (estimated total energy expenditure minus 800-1000 kcal/day) followed by a 36-weight loss maintenance program. Receives: Other: Gradual weight loss (GWL) program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight from baseline to 12 months
Percent total body weight loss (%TBWL) at 12 months follow-up
Measured: Baseline to 1-year
Secondary outcomes (14)
Changes in anthropometric measures
Waist and hip circumference (cm)
Measured: 4-month and 1-year
Changes in body composition 1
Bioelectrical Impedance Analysis (BIA)
Measured: 4-month and 1-year
Changes in body composition 2
Dual-energy X-ray Absorptiometry (DXA) in selected participants
Measured: 4-month and 1-year
Changes in lipids
Total-cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mmol/l)
Measured: 4-month and 1-year
Changes in blood pressure
Systolic and diastolic blood pressure (mm/Hg)
Measured: 4-month and 1-year
Changes in glucose parameters
HbA1c (mmol/mol)
Measured: 4-month and 1-year
Changes in CRP
CRP (mg/L)
Measured: 4-month and 1-year
Changes in Health Related Quality of Life 1
Generic questionnaire: Short Form-36 Health Survey, SF36. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores for each of the 8 domains and summary scores for physical and mental health will be calculated
Measured: 4-month and 1-year
Changes in Health Related Quality of Life 2
Obesity specific questionnaire: IWQOL-lite. The IWQOL-Lite is a 31-item measure of weight-related quality of life. There are five domain scores (Physical Function, Self-Esteem, Sexual Life, Public Distress and Work) and a total score. Scores for all domains and total score range from 0-100, with lower scores indicating greater impairment.
Measured: 4-month and 1-year
Changes in Health Related Quality of Life 3
Weight-related Symptom Measure (WRSM). The validated obesity specific WRSM measures 20 symptoms commonly related to being overweight or obese, including foot problems, joint pain, sensitivity to cold, shortness of breath, etc. using two different sets of items. The first set assesses whether or not a patient is experiencing specific symptoms, and the second set rates the level of the distress of the symptoms with values from zero ("not at all") to six ("bothers a very great deal"). The first set creates an additive scale summing symptoms from 0-20, while the second forms a symptom distress scale ranging from 0-120.
Measured: 4-month and 1-year
Changes in symptoms of depression and anxiety
Hospital Anxiety and Depression Scale (HADS). The validated generic HADS measures symptoms of anxiety and depression using 14 items scored from 0-3 It is decomposed into two domains measuring depression (HADS-D) and anxiety (HADS-A), both consisting of seven items yielding a score from 0-21.
Measured: 4-month and 1-year
Changes in eating behavior
The Three Factor Eating Questionnaire -R 21 (TFEQ-R21) measures eating behaviour and has been validated for use in individuals with obesity and will be used in the study. It consists of 21 items comprising three domain scores; (1) uncontrolled eating; assessing the tendency to lose control over eating when feeling hungry or when exposed to external stimuli, (2) cognitive restraint; assessing the conscious restriction of food intake to control body weight or body shape, and (3) emotional eating; assessing overeating related to negative mood states. The domain scores were transformed to 0-100 scales to facilitate comparison; a higher score indicates more uncontrolled, restraint, or emotional eating.
Measured: 4-month and 1-year
Change in weight from baseline to 4 months
Percent total body weight loss (%TBWL) at 4 months follow-up
Measured: 4-month
Proportions of participants with a TBWL of ≥ 5%, ≥10% and ≥15% at 52-week
TBWL of ≥ 5%, ≥10% and ≥15% at 52-week follow-up
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start11 Apr 2019
- Primary completion16 Sep 2021
- Study completion16 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital of Vestfold
- Sponsor type
- University, hospital or other
- Collaborators
- Roede
- Responsible party
- Principal investigator, Jøran Hjelmesæth, The Hospital of Vestfold
- Investigators
- Jøran Hjelmesæth, Professor, Principal investigator, The Hospital of Vestfold
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776552
- Sponsor's protocol ID
- GoLow
- Acronym
- GoLow
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2018
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT03776552
- Acronym / sponsor ID
- GoLow / GoLow
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- The Hospital of VestfoldUniversity, hospital or other
- Collaborators
- Roede
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 14 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Rapid weight loss (RWL) program | Active comparator | Other: Rapid weight loss (RWL) program16-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. |
| Gradual weight loss (GWL) program | Active comparator | Other: Gradual weight loss (GWL) program16-week GWL-program (estimated total energy expenditure minus 800-1000 kcal/day) followed by a 36-weight loss maintenance program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Willing and able to give informed consent for participation in the study
Key exclusion criteria (3 listed)
- • Pregnancy and breast-feeding mothers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid 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 | Other | Rapid weight loss (RWL) program |
| Gradual weight loss (GWL) program16-week gradual weight loss (GWL) program (moderate calorie restriction) and a subsequent 36-week weight-maintenance follow-up | Other | Gradual weight loss (GWL) program |
Primary outcome
Change in body weight from baseline to 12 months
Time frame: Baseline to 1-year
Percent total body weight loss (%TBWL) at 12 months follow-up
14 secondary outcomes
Changes in anthropometric measures
Time frame: 4-month and 1-year
Changes in body composition 1
Time frame: 4-month and 1-year
Changes in body composition 2
Time frame: 4-month and 1-year
Changes in lipids
Time frame: 4-month and 1-year
Changes in blood pressure
Time frame: 4-month and 1-year
Changes in glucose parameters
Time frame: 4-month and 1-year
Changes in CRP
Time frame: 4-month and 1-year
Changes in Health Related Quality of Life 1
Time frame: 4-month and 1-year
Changes in Health Related Quality of Life 2
Time frame: 4-month and 1-year
Changes in Health Related Quality of Life 3
Time frame: 4-month and 1-year
Changes in symptoms of depression and anxiety
Time frame: 4-month and 1-year
Changes in eating behavior
Time frame: 4-month and 1-year
Change in weight from baseline to 4 months
Time frame: 4-month
Proportions of participants with a TBWL of ≥ 5%, ≥10% and ≥15% at 52-week
Time frame: 1-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jøran Hjelmesæth, Professor principal investigator
The Hospital of Vestfold
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid weight loss (RWL) program and Gradual weight loss (GWL) program in people with Obesity, run by The Hospital of Vestfold at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight from baseline to 12 months (time frame: Baseline to 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.