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ObesityBALANCENCT03550339

Regulation of Energy Balance and Metabolism - Mechanisms Behind and Beyond Obesity and Weight Loss

A study testing SURG, DIET and HAES in people with Obesity and Appetitive Behavior, run by University of Eastern Finland.

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

The study aims to investigate homeostatic and hedonic mechanisms regulating appetite, energy balance and metabolism in obesity and the effects of three distinct obesity treatments on these regulatory mechanisms. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Appetitive Behavior
What is being tested?
SURG, DIET and HAES
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
Nov 2016to Apr 2019
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
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • body mass index >34 kg/m2
  • native finnish speaker
  • right-handed

Who cannot join

  • pregnancy or breast feeding
  • severe visual impairments, severe scalp skin lesions or intracranial bleeding during previous six months
  • severe neurological, psychiatric or cardiovascular disease
  • type 1 or 2 diabetes mellitus
  • use of weight loss medications or other treatments known to affect weight
  • heavy alcohol use
  • any other condition (medical or other) the principal investigator considers as an obstacle to participation

About this study

The study aims to investigate homeostatic and hedonic mechanisms regulating appetite, energy balance and metabolism in obesity and the effects of three distinct obesity treatments on these regulatory mechanisms.

Read the detailed description

Obesity is widely acknowledged health problem affecting millions of people globally. Enormous efforts have been made to solve the problem, but long-term results of the conventional weight loss and/or weight management strategies have been poor indicating still inadequate understanding of the problem. Surgical, rather than weight-centred lifestyle interventions, have proved to be the most effective tool available to treat obesity within individuals suitable for obesity surgery. Current surgical interventions are, however, suitable only for a small subset of obese individuals. In general, there is a need for development of new approaches and therapies that are safer and more individualized to each patient in the struggle against obesity and related disorders. To achieve these goals, research must focus to investigate and understand the complex homeostatic and hedonic regulation of eating behavior and energy balance in different physiological and pathological conditions.

This study aims to investigate homeostatic and hedonic mechanisms regulating energy balance and metabolism in obesity and the effects of three distinct obesity treatments on these regulatory mechanisms. The regulatory mechanisms are investigated at the level of metabolism, autonomic and central nervous systems as well as subjective, both implicit and explicit, experiences.

A total of 90 obese female volunteers (18-65 years, body mass index > 35 kg/m2), of which 30 females waiting for bariatric surgery (SURG), 30 females attending a dietary treatment program for obesity (DIET) and 30 females attending Health at Every Size (HAES) program, will participate in the study. The obesity treatment for SURG and DIET groups follows the principles of the Current Care Guidelines for Obesity (adults) and the treatment for the HAES group applies the strategies of the non-diet wellness-based HAES program. The treatment programs of the DIET and HAES groups include 8-10 weekly group sessions organized by authorised nutritionist.

The study includes also two four-hour visits at the research laboratory of the Institute of Public Health and Clinical Nutrition, University of Eastern Finland, the first visit organized before the participants attend any of the obesity treatments and the second visit 12 months later. During the laboratory visits psychophysiological signals (EEG, ANS, facial EMG and eye tracking) are monitored and blood samples taken throughout the experimental period. Participants will also perform two computer-based test sessions, the first one at baseline and the second before a snack meal. Two meals (breakfast and snack meal) are offered to the participants during the experiment in order to study the regulatory mechanisms of interest both at the homeostatic and hedonic states.

Being tested
SURG, DIET, HAES
Keywords
obesity, appetite, food reward, hormonal responses, psychophysiological responses, implicit measures, explicit measures
Medical subject headings
Obesity, Appetitive Behavior

What participants receive

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

  • SURGProcedure or surgery

    bariatric surgery according to Finnish Current Care Guidelines for Obesity in adults

  • DIETBehavioural

    dietary weight loss program according to Finnish Current Care Guidelines for Obesity in adults

  • HAESBehavioural

    treatment is based on the previously published procedure (e.g. Bacon et al. 2002) and Health At Every Size trademark, consisting of body acceptance, eating behaviour, physical activity, nutrition, and social support

Study groups in NCT03550339
Study groupRoleWhat they receive
SURGActive comparatorsubjects attending bariatric surgery
Receives: Procedure: SURG
DIETActive comparatorsubjects attending dietary weight loss program
Receives: Behavioral: DIET
HAESActive comparatorsubjects attending Health At Every Size weight management program
Receives: Behavioral: HAES

What is being measured

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

  1. Implicit associations

    D-score of Implicit Association Test

    Measured: Change from baseline D-score at 1 year

  2. Explicit ratings

    Ratings on visual analogue scales for wanting and liking of presented foods

    Measured: Change from baseline visual analogue scale at 1 year

Secondary outcomes (10)
  1. Event-related potentials

    Event-related potentials measured by EEG

    Measured: Change from baseline event-related potentials at 1 year

  2. Glucose

    Plasma glucose, fasting, postprandial

    Measured: Change from baseline glucose at 1 year

  3. Insulin

    plasma insulin, fasting, postprandial

    Measured: Change from baseline insulin at 1 year

  4. Ghrelin

    plasma ghrelin, fasting, postprandial

    Measured: Change from baseline ghrelin at 1 year

  5. Leptin

    serum leptin, fasting

    Measured: Change from baseline leptin at 1 year

  6. Peptide YY

    plasma peptide YY, fasting, postprandial

    Measured: Change from baseline PYY at 1 year

  7. Endocannabinoids

    plasma endocannabinoids, fasting, postprandial

    Measured: Change from baseline endocannabinoids at 1 year

  8. Weight

    body weight, fasting

    Measured: Change from baseline weight at 1 year

  9. Eating behaviour

    self-reported questionnaires

    Measured: Change from baseline eating behaviour at 1 year

  10. Psychosocial characteristics

    self-reported questionnaires

    Measured: Change from baseline psychosocial characteristics at 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 posted8 Jun 2018
  2. Study startNov 2016
  3. Primary completionApr 2019
  4. Study completionApr 2019

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
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03550339
Sponsor's protocol ID
327/2016
Acronym
BALANCE
Status last verified
Nov 2019
First submitted
19 Dec 2016
Last updated
5 Nov 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SURG, DIET and HAES in people with Obesity and Appetitive Behavior, run by University of Eastern Finland.

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 3 inclusion and 7 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 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Implicit associations (time frame: Change from baseline D-score at 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 5 Nov 2019.

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