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Effektiviteten av gradvis kontra snabb viktminskning (GoLow)

17 september 2026 uppdaterad av: Jøran Hjelmesæth, The Hospital of Vestfold

Jämförande effektivitet av ett gradvis viktminskningsprogram och ett program för snabb viktminskning (inklusive en lågenergidiet) på 1-årig viktminskning hos personer med fetma - ett randomiserat, parallellt grupp, överlägsenhetsförsök. (GoLow-studien).

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

293

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Tønsberg, Norge
        • Vestfold Hospital Trust

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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).

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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

Aktiv komparator: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in body weight from baseline to 12 months
Tidsram: Baseline to 1-year

Percent total body weight loss (%TBWL) at 12 months follow-up

Baseline to 1-year

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes in anthropometric measures
Tidsram: 4-month and 1-year

Waist and hip circumference (cm)

4-month and 1-year
Changes in body composition 1
Tidsram: 4-month and 1-year

Bioelectrical Impedance Analysis (BIA)

4-month and 1-year
Changes in body composition 2
Tidsram: 4-month and 1-year

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

4-month and 1-year
Changes in lipids
Tidsram: 4-month and 1-year

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

4-month and 1-year
Changes in blood pressure
Tidsram: 4-month and 1-year

Systolic and diastolic blood pressure (mm/Hg)

4-month and 1-year
Changes in glucose parameters
Tidsram: 4-month and 1-year

HbA1c (mmol/mol)

4-month and 1-year
Changes in CRP
Tidsram: 4-month and 1-year

CRP (mg/L)

4-month and 1-year
Changes in Health Related Quality of Life 1
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 1-year

TBWL of ≥ 5%, ≥10% and ≥15% at 52-week follow-up

1-year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Samarbetspartners

Utredare

  • Huvudutredare: Jøran Hjelmesæth, Professor, The Hospital of Vestfold

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

11 april 2019

Primärt slutförande (Faktisk)

16 september 2021

Avslutad studie (Faktisk)

16 september 2021

Studieregistreringsdatum

Först inskickad

12 december 2018

Först inskickad som uppfyllde QC-kriterierna

13 december 2018

Första postat (Faktisk)

14 december 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 september 2026

Senast verifierad

1 september 2026

Mer information

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