CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Multidisciplinary outpatient program +1 morebehavioral
Likely dose
Not stated in record
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Search/NCT01834859
NCT01834859N/ACompleted

How to Optimize Weight Loss Maintenance After a Very-low Calorie Diet?

Norwegian University of Science and Technology·interventional·Posted Apr 18, 2013·Updated Jun 4, 2020

In Brief

A clinical study evaluating Multidisciplinary outpatient program and Inpatient lifestyle program for Obesity, Morbid. Completed, enrolled 100 participants across 1 site.

Detailed Summary

Very-low calorie diets are relatively safe and effective in inducing significant weight loss, when used in selective individuals and under clinical supervision. However, weight loss maintenance in the long-term remains the main challenge, with many experiencing a significant weight regain. Several compensatory mechanisms are activated under weight reduction, both at the level of energy intake (such as increased appetite) and energy expenditure (such as reduced energy expenditure), and increase the risk of relapse. The main aim of this study is to compare the effect of two multidisciplinary lifestyle interventions on weight loss maintenance at one year, after initial weight loss during 8 weeks very-low calorie diet. Participants will be allocated (non-randomly) to either an outpatient program in the obesity unit of the local hospital, or to an inpatient program consisting of a "continuous care" intervention, with three intermittent stays (each with three-week duration) in a rehabilitation center over a one year period. Moreover, the investigators aim to assess the impact of weight loss (achieved with a very low calorie diet) and weight loss maintenance on compensatory mechanisms activated during weight reduction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Morbid
CountriesNorway
CollaboratorsSt. Olavs Hospital

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 18, 2013
Enrollment StartAug 1, 2013
Primary CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 13.2 years ago

Interventions

Multidisciplinary outpatient programbehavioral

Diet (phase 1) and multidisciplinary lifestyle intervention (phase 2)

Inpatient lifestyle programbehavioral

Diet (phase 1) and lifestyle intervention (phase 2)