Completed
How to Optimize Weight Loss Maintenance After a Very-low Calorie Diet?
What is being tested
Multidisciplinary outpatient program
+ Inpatient lifestyle program
Behavioral
Who is being recruted
Body Weight+9
+ Body Weight Changes
+ Nutrition Disorders
From 18 to 65 Years
+16 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: August 2013
Summary
Principal SponsorNorwegian University of Science and Technology
Last updated: June 4, 2020
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2013
Actual date on which the first participant was enrolled.This study included a sub-study (n=30) to determine the timeline over which compensatory mechanisms (at both the level of energy expenditure and appetite control system) are activated with progressive weight loss. Additional measurements were taken at day-3, 5 and 10 % weight loss, and after 4 weeks weight stabilization (after gradually reintroduction of food).
Principal SponsorNorwegian University of Science and Technology
Last updated: June 4, 2020
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Body WeightBody Weight ChangesNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweightObesity, MorbidWeight GainWeight Loss
Criteria
5 inclusion criteria required to participate
body mass index 30-45 kg/m2
if female: taking oral contraceptives or post-menopausal
not currently dieting to lose weight
stable weight ( < 2kg variation in the last 3 months)
Show More Criteria
11 exclusion criteria prevent from participating
Pregnancy
breast feeding
current medication known to affect appetite or induce weight loss
drug or alcohol abuse within the last two years
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalMultidisciplinary outpatient program including both individual and group-based therapy. During the first visit, there will be offered an individual consultation with the dietician, physiotherapist and psychiatric nurse. Follow-up will be in groups meeting every month for the first four months and every two months afterwards up to one year. The intervention will focus on nutritional education, healthy eating, increased physical activity levels (aiming initially at 10 minutes/day, then increasing to 30 minutes/day) and cognitive therapy.
Group II
ExperimentalInpatient lifestyle program consisting of a "continuous care" weight loss program offered at a rehabilitation center, with three intermittent stays (each with 3-week duration) over a one year period.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center