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

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01834859
• Other study ID #: 234
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid
• Weight Loss

Intervention

Behavioral:
• Multidisciplinary outpatient program
Diet (phase 1) and multidisciplinary lifestyle intervention (phase 2)
• Inpatient lifestyle program
Diet (phase 1) and lifestyle intervention (phase 2)

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Nymo S, Coutinho SR, Jørgensen J, Rehfeld JF, Truby H, Kulseng B, Martins C. Timeline of changes in appetite during weight loss with a ketogenic diet. Int J Obes (Lond). 2017 Aug;41(8):1224-1231. doi: 10.1038/ijo.2017.96. Epub 2017 Apr 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight	body weight change after end of very-low calory diet	1 year (changes from baseline to one year)
Secondary	resting metabolic rate, short-term	using indirect calorimetry	10 weeks
Secondary	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	10 weeks
Secondary	exercise efficiency, short-term	assessed through graded cycle ergometry and indirect calorimetry	10 weeks
Secondary	physical activity level, short-term	measurement with arm bands	10 weeks
Secondary	resting metabolic rate, long-term	using indirect calorimetry	1 year
Secondary	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	1 year
Secondary	exercise efficiency, long-term	assessed through graded cycle ergometry and indirect calorimetry	1 year
Secondary	physical activity level, long-term	measurement with arm bands	1 year
Secondary	Sleep duration and quality	Sleep duration and quality will be measured using The Pittsburgh Sleep Quality Index (PSQI)	Baseline, end of weigth loss phase and 1 year