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

June 2, 2020 updated by: Norwegian University of Science and Technology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • St Olavs hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body weight
Time Frame: 1 year (changes from baseline to one year)
body weight change after end of very-low calory diet
1 year (changes from baseline to one year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
resting metabolic rate, short-term
Time Frame: 10 weeks
using indirect calorimetry
10 weeks
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
10 weeks
exercise efficiency, short-term
Time Frame: 10 weeks
assessed through graded cycle ergometry and indirect calorimetry
10 weeks
physical activity level, short-term
Time Frame: 10 weeks
measurement with arm bands
10 weeks
resting metabolic rate, long-term
Time Frame: 1 year
using indirect calorimetry
1 year
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
1 year
exercise efficiency, long-term
Time Frame: 1 year
assessed through graded cycle ergometry and indirect calorimetry
1 year
physical activity level, long-term
Time Frame: 1 year
measurement with arm bands
1 year
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)
Baseline, end of weigth loss phase and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

  • Principal Investigator: Catia Martins, PhD, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

April 15, 2013

First Submitted That Met QC Criteria

April 17, 2013

First Posted (Estimate)

April 18, 2013

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 2, 2020

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 234

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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