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Effectiveness of Gradual Versus Rapid Weight Loss (GoLow)

Primary Purpose

Obesity

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Rapid weight loss (RWL) program
Gradual weight loss (GWL) program
Sponsored by
The Hospital of Vestfold
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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).

Sites / Locations

  • Vestfold Hospital Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Rapid weight loss (RWL) program

Gradual weight loss (GWL) program

Arm 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.

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

Outcomes

Primary Outcome Measures

Change in body weight from baseline to 12 months
Percent total body weight loss (%TBWL) at 12 months follow-up

Secondary Outcome Measures

Changes in anthropometric measures
Waist and hip circumference (cm)
Changes in body composition 1
Bioelectrical Impedance Analysis (BIA)
Changes in body composition 2
Dual-energy X-ray Absorptiometry (DXA) in selected participants
Changes in lipids
Total-cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mmol/l)
Changes in blood pressure
Systolic and diastolic blood pressure (mm/Hg)
Changes in glucose parameters
HbA1c (mmol/mol)
Changes in CRP
CRP (mg/L)
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
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.
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.
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.
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.
Change in weight from baseline to 4 months
Percent total body weight loss (%TBWL) at 4 months follow-up
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

Full Information

First Posted
December 12, 2018
Last Updated
August 11, 2022
Sponsor
The Hospital of Vestfold
Collaborators
Roede AS
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1. Study Identification

Unique Protocol Identification Number
NCT03776552
Brief Title
Effectiveness of Gradual Versus Rapid Weight Loss
Acronym
GoLow
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 11, 2019 (Actual)
Primary Completion Date
September 16, 2021 (Actual)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital of Vestfold
Collaborators
Roede AS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled study
Masking
Outcomes Assessor
Masking Description
Outcome assessor was masked
Allocation
Randomized
Enrollment
293 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rapid weight loss (RWL) program
Arm Type
Active Comparator
Arm 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.
Arm Title
Gradual weight loss (GWL) program
Arm Type
Active Comparator
Arm Description
16-week GWL-program (estimated total energy expenditure minus 800-1000 kcal/day) followed by a 36-weight loss maintenance program.
Intervention Type
Other
Intervention Name(s)
Rapid weight loss (RWL) program
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Gradual weight loss (GWL) program
Intervention Description
16-week gradual weight loss (GWL) program (moderate calorie restriction) and a subsequent 36-week weight-maintenance follow-up
Primary Outcome Measure Information:
Title
Change in body weight from baseline to 12 months
Description
Percent total body weight loss (%TBWL) at 12 months follow-up
Time Frame
Baseline to 1-year
Secondary Outcome Measure Information:
Title
Changes in anthropometric measures
Description
Waist and hip circumference (cm)
Time Frame
4-month and 1-year
Title
Changes in body composition 1
Description
Bioelectrical Impedance Analysis (BIA)
Time Frame
4-month and 1-year
Title
Changes in body composition 2
Description
Dual-energy X-ray Absorptiometry (DXA) in selected participants
Time Frame
4-month and 1-year
Title
Changes in lipids
Description
Total-cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mmol/l)
Time Frame
4-month and 1-year
Title
Changes in blood pressure
Description
Systolic and diastolic blood pressure (mm/Hg)
Time Frame
4-month and 1-year
Title
Changes in glucose parameters
Description
HbA1c (mmol/mol)
Time Frame
4-month and 1-year
Title
Changes in CRP
Description
CRP (mg/L)
Time Frame
4-month and 1-year
Title
Changes in Health Related Quality of Life 1
Description
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
Time Frame
4-month and 1-year
Title
Changes in Health Related Quality of Life 2
Description
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.
Time Frame
4-month and 1-year
Title
Changes in Health Related Quality of Life 3
Description
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.
Time Frame
4-month and 1-year
Title
Changes in symptoms of depression and anxiety
Description
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.
Time Frame
4-month and 1-year
Title
Changes in eating behavior
Description
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.
Time Frame
4-month and 1-year
Title
Change in weight from baseline to 4 months
Description
Percent total body weight loss (%TBWL) at 4 months follow-up
Time Frame
4-month
Title
Proportions of participants with a TBWL of ≥ 5%, ≥10% and ≥15% at 52-week
Description
TBWL of ≥ 5%, ≥10% and ≥15% at 52-week follow-up
Time Frame
1-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jøran Hjelmesæth, Professor
Organizational Affiliation
The Hospital of Vestfold
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vestfold Hospital Trust
City
Tønsberg
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Gradual Versus Rapid Weight Loss

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