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

Not Applicable

Completed

• Conditions: Obesity, Morbid
• Interventions: Behavioral: Multidisciplinary outpatient program; Behavioral: Inpatient lifestyle program

• Registration Number: NCT01834859
• Lead Sponsor: Norwegian University of Science and Technology

Brief 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).

Study Timeline

• Study First Submitted: 2013-04-15
• Study First Submitted QC: 2013-04-17
• Study First Posted: 2013-04-18
• Study Start: 2013-08
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2020-06-02
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• volunteers from Central Norway
• if female: taking oral contraceptives or post-menopausal
• body mass index 30-45 kg/m2
• stable weight (<2kg variation in the last 3 months)
• not currently dieting to lose weight

Exclusion Criteria

• Pregnancy
• breast feeding
• drug or alcohol abuse within the last two years
• current medication known to affect appetite or induce weight loss
• enrollment in another obesity treatment program
• history of psychological disorders
• history of eating disorders
• history of diabetes type 1 or 2
• gastrointestinal disorders (particular cholelithiasis)
• kidney -, liver -, lung- or cardiovascular disease
• malignancies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Outpatient	Multidisciplinary outpatient program	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.
Inpatient	Inpatient lifestyle 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.

Primary Outcome Measures

Name	Time	Method
body weight	1 year (changes from baseline to one year)	body weight change after end of very-low calory diet

Secondary Outcome Measures

Name	Time	Method
resting metabolic rate, long-term	1 year	using indirect calorimetry
Sleep duration and quality	Baseline, end of weigth loss phase and 1 year	Sleep duration and quality will be measured using The Pittsburgh Sleep Quality Index (PSQI)
resting metabolic rate, short-term	10 weeks	using indirect calorimetry
appetite, long-term	1 year	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
appetite, short-term	10 weeks	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
exercise efficiency, long-term	1 year	assessed through graded cycle ergometry and indirect calorimetry
physical activity level, long-term	1 year	measurement with arm bands
exercise efficiency, short-term	10 weeks	assessed through graded cycle ergometry and indirect calorimetry
physical activity level, short-term	10 weeks	measurement with arm bands

Trial Locations

Locations (1)

St Olavs Hospital; 🇳🇴 Trondheim, Norway