- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03776552
Effectiveness of Gradual Versus Rapid Weight Loss (GoLow)
November 24, 2023 updated by: Jøran Hjelmesæth, The Hospital of Vestfold
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
293
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tønsberg, Norway
- Vestfold Hospital trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Rapid weight loss (RWL) program
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.
|
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
|
Active Comparator: Gradual weight loss (GWL) program
16-week GWL-program (estimated total energy expenditure minus 800-1000 kcal/day) followed by a 36-weight loss maintenance program.
|
16-week gradual weight loss (GWL) program (moderate calorie restriction) and a subsequent 36-week weight-maintenance follow-up
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline to 1-year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in anthropometric measures
Time Frame: 4-month and 1-year
|
Waist and hip circumference (cm)
|
4-month and 1-year
|
Changes in body composition 1
Time Frame: 4-month and 1-year
|
Bioelectrical Impedance Analysis (BIA)
|
4-month and 1-year
|
Changes in body composition 2
Time Frame: 4-month and 1-year
|
Dual-energy X-ray Absorptiometry (DXA) in selected participants
|
4-month and 1-year
|
Changes in lipids
Time Frame: 4-month and 1-year
|
Total-cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mmol/l)
|
4-month and 1-year
|
Changes in blood pressure
Time Frame: 4-month and 1-year
|
Systolic and diastolic blood pressure (mm/Hg)
|
4-month and 1-year
|
Changes in glucose parameters
Time Frame: 4-month and 1-year
|
HbA1c (mmol/mol)
|
4-month and 1-year
|
Changes in CRP
Time Frame: 4-month and 1-year
|
CRP (mg/L)
|
4-month and 1-year
|
Changes in Health Related Quality of Life 1
Time Frame: 4-month and 1-year
|
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
|
4-month and 1-year
|
Changes in Health Related Quality of Life 2
Time Frame: 4-month and 1-year
|
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.
|
4-month and 1-year
|
Changes in Health Related Quality of Life 3
Time Frame: 4-month and 1-year
|
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.
|
4-month and 1-year
|
Changes in symptoms of depression and anxiety
Time Frame: 4-month and 1-year
|
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.
|
4-month and 1-year
|
Changes in eating behavior
Time Frame: 4-month and 1-year
|
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.
|
4-month and 1-year
|
Change in weight from baseline to 4 months
Time Frame: 4-month
|
Percent total body weight loss (%TBWL) at 4 months follow-up
|
4-month
|
Proportions of participants with a TBWL of ≥ 5%, ≥10% and ≥15% at 52-week
Time Frame: 1-year
|
TBWL of ≥ 5%, ≥10% and ≥15% at 52-week follow-up
|
1-year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jøran Hjelmesæth, Professor, The Hospital of Vestfold
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 11, 2019
Primary Completion (Actual)
September 16, 2021
Study Completion (Estimated)
December 31, 2028
Study Registration Dates
First Submitted
December 12, 2018
First Submitted That Met QC Criteria
December 13, 2018
First Posted (Actual)
December 14, 2018
Study Record Updates
Last Update Posted (Actual)
November 27, 2023
Last Update Submitted That Met QC Criteria
November 24, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GoLow
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Rapid weight loss (RWL) program
-
University of North Carolina, Chapel HillCompletedOverweight and ObesityUnited States
-
Rush University Medical CenterCompleted
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
Dana-Farber Cancer InstituteCompletedWeight Loss Program After Cancer DiagnosisUnited States
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
University of South AlabamaAmerican Society for Metabolic and Bariatric SurgeryCompletedType 2 DiabetesUnited States
-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI); Healthways, Inc.Completed
-
Stanford UniversityTerminatedOverweight | Miscarriage | Obese | Recurrent Pregnancy LossUnited States
-
University Medical Centre LjubljanaSlovenian Research AgencyCompletedWeight LossSlovenia
-
University of ManitobaCompleted