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Obesity, MorbidNCT01834859

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

A study testing Multidisciplinary outpatient program and Inpatient lifestyle program in people with Obesity, Morbid, run by Norwegian University of Science and Technology at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity, Morbid
What is being tested?
Multidisciplinary outpatient program and Inpatient lifestyle program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteNorway
Study dates
Aug 2013to Oct 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • history of eating disorders
  • history of diabetes type 1 or 2
  • gastrointestinal disorders (particular cholelithiasis)
  • kidney -, liver -, lung- or cardiovascular disease
  • malignancies

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • St Olavs Hospital

    Trondheim

Other trials in Norway

About this study

Official title: 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.

Read the 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).

Conditions
Obesity, Morbid
Being tested
Multidisciplinary outpatient program, Inpatient lifestyle program
Keywords
weight reduction programs, diet, Caloric restriction, weight loss, weight gain
Medical subject headings
Obesity, Morbid, Weight Loss, Weight Gain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multidisciplinary outpatient programBehavioural

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

  • Inpatient lifestyle programBehavioural

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

Study groups in NCT01834859
Study groupRoleWhat they receive
OutpatientExperimentalMultidisciplinary 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.
Receives: Behavioral: Multidisciplinary outpatient program
InpatientExperimentalInpatient 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.
Receives: Behavioral: Inpatient lifestyle program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. body weight

    body weight change after end of very-low calory diet

    Measured: 1 year (changes from baseline to one year)

Secondary outcomes (9)

  1. resting metabolic rate, short-term

    using indirect calorimetry

    Measured: 10 weeks

  2. 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

    Measured: 10 weeks

  3. exercise efficiency, short-term

    assessed through graded cycle ergometry and indirect calorimetry

    Measured: 10 weeks

  4. physical activity level, short-term

    measurement with arm bands

    Measured: 10 weeks

  5. resting metabolic rate, long-term

    using indirect calorimetry

    Measured: 1 year

  6. 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

    Measured: 1 year

  7. exercise efficiency, long-term

    assessed through graded cycle ergometry and indirect calorimetry

    Measured: 1 year

  8. physical activity level, long-term

    measurement with arm bands

    Measured: 1 year

  9. Sleep duration and quality

    Sleep duration and quality will be measured using The Pittsburgh Sleep Quality Index (PSQI)

    Measured: Baseline, end of weigth loss phase and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01834859
Sponsor's protocol ID
234
Status last verified
Oct 2016
First submitted
15 Apr 2013
Last updated
4 Jun 2020
Results posted
No
Data monitoring committee
No

Publications

  • Nymo S, Coutinho SR, Jorgensen 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.

    PubMed 28439092

  • Martins C, Nymo S, Aukan MI, Roekenes JA, Coutinho SR, Hunter GR, Gower BA. Association between ss-Hydroxybutyrate Plasma Concentrations after Hypocaloric Ketogenic Diets and Changes in Body Composition. J Nutr. 2023 Jul;153(7):1944-1949. doi: 10.1016/j.tjnut.2023.05.010. Epub 2023 May 12.

    PubMed 37182692

  • Martins C, Nymo S, Coutinho SR, Rehfeld JF, Hunter GR, Gower BA. Association between Fat-Free Mass Loss, Changes in Appetite, and Weight Regain in Individuals with Obesity. J Nutr. 2023 May;153(5):1330-1337. doi: 10.1016/j.tjnut.2023.03.026. Epub 2023 Mar 23.

    PubMed 36963504

  • Martins C, Nymo S, Truby H, Rehfeld JF, Hunter GR, Gower BA. Association Between Ketosis and Changes in Appetite Markers with Weight Loss Following a Very Low-Energy Diet. Obesity (Silver Spring). 2020 Dec;28(12):2331-2338. doi: 10.1002/oby.23011.

    PubMed 33230962

  • DeBenedictis JN, Nymo S, Ollestad KH, Boyesen GA, Rehfeld JF, Holst JJ, Truby H, Kulseng B, Martins C. Changes in the Homeostatic Appetite System After Weight Loss Reflect a Normalization Toward a Lower Body Weight. J Clin Endocrinol Metab. 2020 Jul 1;105(7):e2538-46. doi: 10.1210/clinem/dgaa202.

    PubMed 32301981

  • Lyngstad A, Nymo S, Coutinho SR, Rehfeld JF, Truby H, Kulseng B, Martins C. Investigating the effect of sex and ketosis on weight-loss-induced changes in appetite. Am J Clin Nutr. 2019 Jun 1;109(6):1511-1518. doi: 10.1093/ajcn/nqz002.

    PubMed 31070711

  • Nymo S, Coutinho SR, Rehfeld JF, Truby H, Kulseng B, Martins C. Physiological Predictors of Weight Regain at 1-Year Follow-Up in Weight-Reduced Adults with Obesity. Obesity (Silver Spring). 2019 Jun;27(6):925-931. doi: 10.1002/oby.22476. Epub 2019 Apr 20.

    PubMed 31004405

Questions about this trial

What is this clinical trial studying?

A study testing Multidisciplinary outpatient program and Inpatient lifestyle program in people with Obesity, Morbid, run by Norwegian University of Science and Technology at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

body weight (time frame: 1 year (changes from baseline to one year)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01834859, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.

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