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NCT Number: NCT03776552

Effectiveness of Gradual Versus Rapid Weight Loss

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vestfold Hospital Trust

Tønsberg, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Rapid weight loss (RWL) program

Other

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) program

Other

16-week gradual weight loss (GWL) program (moderate calorie restriction) and a subsequent 36-week weight-maintenance follow-up

Primary outcomes

  1. 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

Secondary outcomes

  1. Changes in anthropometric measures

    Time frame: 4-month and 1-year

    Waist and hip circumference (cm)

  2. Changes in body composition 1

    Time frame: 4-month and 1-year

    Bioelectrical Impedance Analysis (BIA)

  3. Changes in body composition 2

    Time frame: 4-month and 1-year

    Dual-energy X-ray Absorptiometry (DXA) in selected participants

  4. Changes in lipids

    Time frame: 4-month and 1-year

    Total-cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mmol/l)

  5. Changes in blood pressure

    Time frame: 4-month and 1-year

    Systolic and diastolic blood pressure (mm/Hg)

  6. Changes in glucose parameters

    Time frame: 4-month and 1-year

    HbA1c (mmol/mol)

  7. Changes in CRP

    Time frame: 4-month and 1-year

    CRP (mg/L)

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Change in weight from baseline to 4 months

    Time frame: 4-month

    Percent total body weight loss (%TBWL) at 4 months follow-up

  14. 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

Sponsors and collaborators

Lead sponsor

The Hospital of Vestfold

Other

Collaborators

  • Roede AS

Registry information

Official study 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).

Acronym: GoLow

Important dates

Study start
2019
Primary completion
2021
Study completion
2028
First posted
Dec 14, 2018
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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