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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Norwegian University of Science and Technology
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01834859
First received: April 15, 2013
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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 Intervention
Obesity, Morbid
Behavioral: Multidisciplinary outpatient program
Behavioral: Inpatient lifestyle program

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: How to Optimize Weight Loss Maintenance After a Very-low Calorie Diet?

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • body weight [ Time Frame: 1 year (changes from baseline to one year) ] [ Designated as safety issue: No ]
    body weight change after end of very-low calory diet


Secondary Outcome Measures:
  • resting metabolic rate, short-term [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    using indirect calorimetry

  • appetite, short-term [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

    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, short-term [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    assessed through graded cycle ergometry and indirect calorimetry

  • physical activity level, short-term [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    measurement with arm bands

  • resting metabolic rate, long-term [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    using indirect calorimetry

  • appetite, long-term [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    assessed through graded cycle ergometry and indirect calorimetry

  • physical activity level, long-term [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    measurement with arm bands

  • Sleep duration and quality [ Time Frame: Baseline, end of weigth loss phase and 1 year ] [ Designated as safety issue: No ]
    Sleep duration and quality will be measured using The Pittsburgh Sleep Quality Index (PSQI)


Estimated Enrollment: 60
Study Start Date: August 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01834859

Contacts
Contact: Catia Martins, phd 004772825358 catia.martins@ntnu.no
Contact: Bård Kulseng, md phd 004748306262 baard.kulseng@ntnu.no

Locations
Norway
St Olavs Hospital Recruiting
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

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01834859     History of Changes
Other Study ID Numbers: 234
Study First Received: April 15, 2013
Last Updated: January 22, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

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

ClinicalTrials.gov processed this record on July 22, 2014