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NCT Number: NCT01834859

Weight Loss Maintenance and Compensatory Mechanisms Activated With 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.

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Key information

Conditions

Obesity, Morbid Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital

Trondheim, Norway

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multidisciplinary outpatient program

Behavioral

Diet (phase 1) and multidisciplinary lifestyle intervention (phase 2)

Inpatient lifestyle program

Behavioral

Diet (phase 1) and lifestyle intervention (phase 2)

Primary outcomes

  1. body weight

    Time frame: 1 year (changes from baseline to one year)

    body weight change after end of very-low calory diet

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 18, 2013
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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