An interventional study of Multidisciplinary outpatient program and Inpatient lifestyle program in Obesity, Morbid, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Treatment
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.
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).
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's enrollment of 100 is above the median of 60 across 590 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
Multidisciplinary 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.
Behavioral: Multidisciplinary outpatient program
Inpatient 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.
Behavioral: Inpatient lifestyle program
Diet (phase 1) and multidisciplinary lifestyle intervention (phase 2)
Diet (phase 1) and lifestyle intervention (phase 2)
body weight
body weight change after end of very-low calory diet
Time frame: 1 year (changes from baseline to one year)
resting metabolic rate, short-term
using indirect calorimetry
Time frame: 10 weeks
appetite, short-term
assessed through: * the Three-Factor Eating Questionnaire (TFEQ) * fasting and postprandial release of appetite related hormones in blood samples, for a period of 3h (0, 30, 60, 120, 180 minutes), after a standard breakfast * feelings of hunger/fullness by a visual analog scale
Time frame: 10 weeks
exercise efficiency, short-term
assessed through graded cycle ergometry and indirect calorimetry
Time frame: 10 weeks
physical activity level, short-term
measurement with arm bands
Time frame: 10 weeks
resting metabolic rate, long-term
using indirect calorimetry
Time frame: 1 year
appetite, long-term
assessed through: * the Three-Factor Eating Questionnaire (TFEQ) * fasting and postprandial release of appetite related hormones in blood samples, for a period of 3h (0, 30, 60, 120, 180 minutes), after a standard breakfast * feelings of hunger/fullness by a visual analog scale
Time frame: 1 year
exercise efficiency, long-term
assessed through graded cycle ergometry and indirect calorimetry
Time frame: 1 year
physical activity level, long-term
measurement with arm bands
Time frame: 1 year
Sleep duration and quality
Sleep duration and quality will be measured using The Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, end of weigth loss phase and 1 year
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Norwegian University of Science and Technology