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.
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
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- 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.
- Conditions
- Obesity, Appetitive Behavior
- 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 group | Role | What they receive |
|---|---|---|
| SURG | Active comparator | subjects attending bariatric surgery Receives: Procedure: SURG |
| DIET | Active comparator | subjects attending dietary weight loss program Receives: Behavioral: DIET |
| HAES | Active comparator | subjects 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.
Implicit associations
D-score of Implicit Association Test
Measured: Change from baseline D-score at 1 year
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)
Event-related potentials
Event-related potentials measured by EEG
Measured: Change from baseline event-related potentials at 1 year
Glucose
Plasma glucose, fasting, postprandial
Measured: Change from baseline glucose at 1 year
Insulin
plasma insulin, fasting, postprandial
Measured: Change from baseline insulin at 1 year
Ghrelin
plasma ghrelin, fasting, postprandial
Measured: Change from baseline ghrelin at 1 year
Leptin
serum leptin, fasting
Measured: Change from baseline leptin at 1 year
Peptide YY
plasma peptide YY, fasting, postprandial
Measured: Change from baseline PYY at 1 year
Endocannabinoids
plasma endocannabinoids, fasting, postprandial
Measured: Change from baseline endocannabinoids at 1 year
Weight
body weight, fasting
Measured: Change from baseline weight at 1 year
Eating behaviour
self-reported questionnaires
Measured: Change from baseline eating behaviour at 1 year
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.
- First posted8 Jun 2018
- Study startNov 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Collaborators
- VTT Technical Research Centre of Finland, Kuopio University Hospital, Alfido Ltd
- Responsible party
- Sponsor
- Investigators
- Leila J Karhunen, PhD, Principal investigator, University of Eastern Finland
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Energy Balance and Metabolism - Mechanisms Behind and Beyond Obesity and Weight Loss
- ClinicalTrials.gov ID
- NCT03550339
- Acronym / sponsor ID
- BALANCE / 327/2016
- Conditions
- Obesity, Appetitive Behavior
- Keywords
- obesity, appetite, food reward, hormonal responses, psychophysiological responses, implicit measures, explicit measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Collaborators
- VTT Technical Research Centre of Finland, Kuopio University Hospital, Alfido Ltd
- Study start
- Nov 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SURG | Active comparator | Procedure: SURGsubjects attending bariatric surgery |
| DIET | Active comparator | Behavioral: DIETsubjects attending dietary weight loss program |
| HAES | Active comparator | Behavioral: HAESsubjects attending Health At Every Size weight management program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- body mass index >34 kg/m2
- native finnish speaker
- right-handed
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SURGbariatric surgery according to Finnish Current Care Guidelines for Obesity in adults | Procedure or surgery | SURG |
| DIETdietary weight loss program according to Finnish Current Care Guidelines for Obesity in adults | Behavioural | DIET |
| HAEStreatment 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 | Behavioural | HAES |
Primary outcome
Implicit associations
Time frame: Change from baseline D-score at 1 year
D-score of Implicit Association Test
Explicit ratings
Time frame: Change from baseline visual analogue scale at 1 year
Ratings on visual analogue scales for wanting and liking of presented foods
10 secondary outcomes
Event-related potentials
Time frame: Change from baseline event-related potentials at 1 year
Glucose
Time frame: Change from baseline glucose at 1 year
Insulin
Time frame: Change from baseline insulin at 1 year
Ghrelin
Time frame: Change from baseline ghrelin at 1 year
Leptin
Time frame: Change from baseline leptin at 1 year
Peptide YY
Time frame: Change from baseline PYY at 1 year
Endocannabinoids
Time frame: Change from baseline endocannabinoids at 1 year
Weight
Time frame: Change from baseline weight at 1 year
Eating behaviour
Time frame: Change from baseline eating behaviour at 1 year
Psychosocial characteristics
Time frame: Change from baseline psychosocial characteristics at 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leila J Karhunen, PhD principal investigator
University of Eastern Finland
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.