Clinical Trials Directory

Trials / Completed

CompletedNCT01834859

Weight Loss Maintenance and Compensatory Mechanisms Activated With a Very-low Calorie Diet

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
Norwegian University of Science and Technology · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Detailed description

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).

Conditions

Interventions

TypeNameDescription
BEHAVIORALMultidisciplinary outpatient programDiet (phase 1) and multidisciplinary lifestyle intervention (phase 2)
BEHAVIORALInpatient lifestyle programDiet (phase 1) and lifestyle intervention (phase 2)

Timeline

Start date
2013-08-01
Primary completion
2016-10-01
Completion
2016-10-01
First posted
2013-04-18
Last updated
2020-06-04

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT01834859. Inclusion in this directory is not an endorsement.