Effectiveness of Gradual Versus Rapid Weight Loss

NCT03776552 | Active Not Recruiting

• 1 other identifier: GoLow
• Study Type: interventional
• Target: 293
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Changes in anthropometric measures

  4-month and 1-year

• Changes in body composition 1

  4-month and 1-year

• Changes in body composition 2

  4-month and 1-year

• Changes in lipids

  4-month and 1-year

• Changes in blood pressure

  4-month and 1-year

Study Arms (2)

Rapid weight loss (RWL) program

ACTIVE COMPARATOR

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.

Other: Rapid weight loss (RWL) program

Gradual weight loss (GWL) program

ACTIVE COMPARATOR

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

Other: Gradual weight loss (GWL) program

Interventions

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

Rapid weight loss (RWL) program

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

Gradual weight loss (GWL) program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Hospital of Vestfold: lead
• Roede AS: collaborator

Study Sites (1)

Vestfold Hospital Trust

Tønsberg, Norway

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Jøran Hjelmesæth, Professor

  The Hospital of Vestfold

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor was masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 14, 2018
• Study Start: April 11, 2019
• Primary Completion: September 16, 2021
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)