Effectiveness of Gradual Versus Rapid Weight Loss

Obesity Clinical Trial

— 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).

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03776552
• Other study ID #: GoLow
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 11, 2019
• Est. completion date: December 31, 2028

Study information

• Verified date: November 2023
• Source: The Hospital of Vestfold
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 293
• Est. completion date: December 31, 2028
• Est. primary completion date: September 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Other:
• Rapid weight loss (RWL) 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
• Gradual weight loss (GWL) program
16-week gradual weight loss (GWL) program (moderate calorie restriction) and a subsequent 36-week weight-maintenance follow-up

Locations

Country	Name	City	State
Norway	Vestfold Hospital Trust	Tønsberg

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital of Vestfold	Roede AS

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight from baseline to 12 months	Percent total body weight loss (%TBWL) at 12 months follow-up	Baseline to 1-year
Secondary	Changes in anthropometric measures	Waist and hip circumference (cm)	4-month and 1-year
Secondary	Changes in body composition 1	Bioelectrical Impedance Analysis (BIA)	4-month and 1-year
Secondary	Changes in body composition 2	Dual-energy X-ray Absorptiometry (DXA) in selected participants	4-month and 1-year
Secondary	Changes in lipids	Total-cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mmol/l)	4-month and 1-year
Secondary	Changes in blood pressure	Systolic and diastolic blood pressure (mm/Hg)	4-month and 1-year
Secondary	Changes in glucose parameters	HbA1c (mmol/mol)	4-month and 1-year
Secondary	Changes in CRP	CRP (mg/L)	4-month and 1-year
Secondary	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	4-month and 1-year
Secondary	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.	4-month and 1-year
Secondary	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.	4-month and 1-year
Secondary	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.	4-month and 1-year
Secondary	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.	4-month and 1-year
Secondary	Change in weight from baseline to 4 months	Percent total body weight loss (%TBWL) at 4 months follow-up	4-month
Secondary	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	1-year