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

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.

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

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.

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