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

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ClinicalTrials.gov Identifier: NCT01834859
Recruitment Status : Completed
First Posted : April 18, 2013
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Obesity, Morbid Behavioral: Multidisciplinary outpatient program Behavioral: Inpatient lifestyle program

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: How to Optimize Weight Loss Maintenance After a Very-low Calorie Diet?
Study Start Date : August 2013
Primary Completion Date : October 2016
Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Outpatient
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
Diet (phase 1) and multidisciplinary lifestyle intervention (phase 2)
Experimental: Inpatient
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 lifestyle intervention (phase 2)


Outcome Measures

Primary Outcome Measures :
  1. body weight [ Time Frame: 1 year (changes from baseline to one year) ]
    body weight change after end of very-low calory diet


Secondary Outcome Measures :
  1. resting metabolic rate, short-term [ Time Frame: 10 weeks ]
    using indirect calorimetry

  2. appetite, short-term [ Time Frame: 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

  3. exercise efficiency, short-term [ Time Frame: 10 weeks ]
    assessed through graded cycle ergometry and indirect calorimetry

  4. physical activity level, short-term [ Time Frame: 10 weeks ]
    measurement with arm bands

  5. resting metabolic rate, long-term [ Time Frame: 1 year ]
    using indirect calorimetry

  6. appetite, long-term [ Time Frame: 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

  7. exercise efficiency, long-term [ Time Frame: 1 year ]
    assessed through graded cycle ergometry and indirect calorimetry

  8. physical activity level, long-term [ Time Frame: 1 year ]
    measurement with arm bands

  9. Sleep duration and quality [ Time Frame: Baseline, end of weigth loss phase and 1 year ]
    Sleep duration and quality will be measured using The Pittsburgh Sleep Quality Index (PSQI)


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834859


Locations
Norway
St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Principal Investigator: Catia Martins, phd Norwegian University of Science and Technology
More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01834859     History of Changes
Other Study ID Numbers: 234
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Norwegian University of Science and Technology:
weight reduction programs
diet
Caloric restriction
weight loss
weight gain

Additional relevant MeSH terms:
Weight Loss
Obesity, Morbid
Body Weight Changes
Body Weight
Signs and Symptoms
Obesity
Overnutrition
Nutrition Disorders
Overweight