Overweight and ObesityBELITANCT03306069
Effects of Low-volume Aerobic Interval Training in Overweight Individuals at Increased Cardiometabolic Risk
A study testing HIIT, MIIT-HR and MIIT-LT in people with Overweight and Obesity and Metabolic Syndrome, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The main purpose of this study is to compare the impact of aerobic interval training intensity on exercise adherence and changes in cardiorespiratory fitness, cardiometabolic risk profile, body composition, inflammatory markers and subjective health outcomes after a 12-week intervention trial in overweight individuals… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight and Obesity, Metabolic Syndrome
- What is being tested?
- HIIT, MIIT-HR and MIIT-LT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2017to 15 Apr 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index >/=30
- presence of at least 2 cardiometabolic risk factors
Who cannot join
- Healthy persons or patients under age
- Overweight persons without any additional cardiometabolic risk factors
- Pregnancy, Lactation
- Psychological disorders, epilepsy, sever neurological disorders
- Participation in other exercise- or nutrition studies within the last 6 months
- acute cardiovascular disease
Show all 9Show fewer
- malignant disease
- Electronic implants (defibrillator, pacemaker)
- Persons in mental hospitals by order of authorities or jurisdiction
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports,
Erlangen, 91052
About this study
Official title: Low-volume Aerobic Interval Training in Overweight Individuals at Increased Cardiometabolic Risk: Impact of Training Intensity on Cardiorespiratory Fitness, Cardiometabolic Risk Profile and Exercise Adherence
The main purpose of this study is to compare the impact of aerobic interval training intensity on exercise adherence and changes in cardiorespiratory fitness, cardiometabolic risk profile, body composition, inflammatory markers and subjective health outcomes after a 12-week intervention trial in overweight individuals at increased cardiometabolic risk.
- Conditions
- Overweight and Obesity, Metabolic Syndrome
- Being tested
- Control, HIIT, MIIT-HR, MIIT-LT
- Keywords
- Aerobic exercise, Interval training, VO2max, Health Promotion, Inflammation, Body Composition
- Medical subject headings
- Overweight, Obesity, Metabolic Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Individualized, weight-reducing nutritional therapy and counseling, during a study period of 12 weeks
HIITOther
Procedures: Nutritional therapy (individualized, weightreducing nutritional therapy and counseling) during a study period of 12 weeks combined with supervised ergometer-based high-intensity interval training (HIIT).
HIIT:
- 2 sessions per week
- 5x1 min at 80-95% HRmax
- time-effort per week: ~30 min
MIIT-HROther
Procedures: Nutritional therapy (individualized, weightreducing nutritional therapy and counseling) during a study period of 12 weeks combined with supervised ergometer-based moderate-intensity interval training on the basis of HRmax (MIIT-HR).
MIIT-HR:
- 2 sessions per week
- 5x1 min at 65-79% HRmax
- time-effort per week: ~30 min
MIIT-LTOther
Procedures: Nutritional therapy (individualized, weightreducing nutritional therapy and counseling) during a study period of 12 weeks combined with supervised ergometer-based moderate-intensity interval training on the basis of lactate threshold (MIIT-LT).
MIIT-LT:
- 2 sessions per week
- session 1: 2x4 min / session 2: 5x1 min, each at 105% LT
- time-effort per week: ~30 min
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Nutritional therapy / no exercise Receives: Other: Control |
| HIIT | Experimental | High-intensity interval training (HIIT) at 90% heart rate maximum (HRmax) combined with Nutritional therapy Receives: Other: HIIT |
| MIIT-HR | Experimental | Heart rate based moderate-intensity interval training (MIIT-HR) at 70% heart rate maximum (HRmax) combined with Nutritional therapy Receives: Other: MIIT-HR |
| MIIT-LT | Experimental | Lactate threshold based moderate-intensity interval training (MIIT-LT) at 105% of lactate threshold (corresponding ~70-75% HRmax) combined with Nutritional therapy Receives: Other: MIIT-LT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory Fitness (CRF)
CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)
Measured: 12 weeks (baseline to 12 week follow-up assessment)
Secondary outcomes (8)
Metabolic Syndrome Z-Score (MetS-Z-Score)
MetS-Z-Score will be calculated from each individual's measures of waist circumference, mean arterial blood pressure, triglycerides, and HDL-cholesterol, based on equations specific to sex.
Measured: 12 weeks (baseline to 12 week follow-up assessment)
Body Composition
Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA)
Measured: 12 weeks (baseline to 12 week follow-up assessment)
Insulin sensitivity
Insulin sensitivity will be estimated using homeostasis model assessment index (HOMA)
Measured: 12 weeks (baseline to 12 week follow-up assessment)
Inflammation
Inflammation will be assessed by measuring levels of inflammatory blood markers
Measured: 12 weeks (baseline to 12 week follow-up assessment)
Health-related quality of life
Health-related quality of life will be assessed by using the standardized and validated EQ-5D-5L Questionnaire
Measured: 12 weeks (baseline to 12 week follow-up assessment)
Pain scores
Pain scores will be assessed by using the standardized and validated Chronic Pain Grade Questionnaire (CPGQ)
Measured: 12 weeks (baseline to 12 week follow-up assessment)
Perceived stress
Perceived stress will be assessed by using the standardized and validated Perceived Stress Questionnaire (PSQ)
Measured: 12 weeks (baseline to 12 week follow-up assessment)
Subjective work ability
Subjective work ability will be assessed by using the standardized and validated Work Ability Index Questionnaire (WAI)
Measured: 12 weeks (baseline to 12 week follow-up assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start1 Nov 2017
- Primary completion15 Feb 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment parallel-group, randomized-controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dejan Reljic, Dr., Principal investigator, University Erlangen Nuremberg Medical SchoolYurdaguel Zopf, Prof., Principal investigator, University Erlangen Nuremberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306069
- Sponsor's protocol ID
- BELITA-Study
- Acronym
- BELITA
- Status last verified
- Sep 2020
- First submitted
- 27 Sep 2017
- Last updated
- 14 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reljic D, Frenk F, Herrmann HJ, Neurath MF, Zopf Y. Low-volume high-intensity interval training improves cardiometabolic health, work ability and well-being in severely obese individuals: a randomized-controlled trial sub-study. J Transl Med. 2020 Nov 7;18(1):419. doi: 10.1186/s12967-020-02592-6.
PubMed 33160382
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-volume Aerobic Interval Training in Overweight Individuals at Increased Cardiometabolic Risk: Impact of Training Intensity on Cardiorespiratory Fitness, Cardiometabolic Risk Profile and Exercise Adherence
- ClinicalTrials.gov ID
- NCT03306069
- Acronym / sponsor ID
- BELITA / BELITA-Study
- Conditions
- Overweight and Obesity, Metabolic Syndrome
- Keywords
- Aerobic exercise, Interval training, VO2max, Health Promotion, Inflammation, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 10 Oct 2017 (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 main purpose of this study is to compare the impact of aerobic interval training intensity on exercise adherence and changes in cardiorespiratory fitness, cardiometabolic risk profile, body composition, inflammatory markers and subjective health outcomes after a 12-week intervention trial in overweight individuals at increased cardiometabolic risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Parallel Assignment parallel-group, randomized-controlled study
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: ControlNutritional therapy / no exercise |
| HIIT | Experimental | Other: HIITHigh-intensity interval training (HIIT) at 90% heart rate maximum (HRmax) combined with Nutritional therapy |
| MIIT-HR | Experimental | Other: MIIT-HRHeart rate based moderate-intensity interval training (MIIT-HR) at 70% heart rate maximum (HRmax) combined with Nutritional therapy |
| MIIT-LT | Experimental | Other: MIIT-LTLactate threshold based moderate-intensity interval training (MIIT-LT) at 105% of lactate threshold (corresponding ~70-75% HRmax) combined with Nutritional therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body Mass Index >/=30
- presence of at least 2 cardiometabolic risk factors
Key exclusion criteria (9 listed)
- Healthy persons or patients under age
- Overweight persons without any additional cardiometabolic risk factors
- Pregnancy, Lactation
- Psychological disorders, epilepsy, sever neurological disorders
- Participation in other exercise- or nutrition studies within the last 6 months
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 |
|---|---|---|
| ControlIndividualized, weight-reducing nutritional therapy and counseling, during a study period of 12 weeks | Other | Control |
| HIITProcedures: Nutritional therapy (individualized, weightreducing nutritional therapy and counseling) during a study period of 12 weeks combined with supervised ergometer-based high-intensity interval training (HIIT). HIIT: * 2 sessions per week * 5x1 min at 80-95% HRmax * time-effort per week: ~30 min | Other | HIIT |
| MIIT-HRProcedures: Nutritional therapy (individualized, weightreducing nutritional therapy and counseling) during a study period of 12 weeks combined with supervised ergometer-based moderate-intensity interval training on the basis of HRmax (MIIT-HR). MIIT-HR: * 2 sessions per week * 5x1 min at 65-79% HRmax * time-effort per week: ~30 min | Other | MIIT-HR |
| MIIT-LTProcedures: Nutritional therapy (individualized, weightreducing nutritional therapy and counseling) during a study period of 12 weeks combined with supervised ergometer-based moderate-intensity interval training on the basis of lactate threshold (MIIT-LT). MIIT-LT: * 2 sessions per week * session 1: 2x4 min / session 2: 5x1 min, each at 105% LT * time-effort per week: ~30 min | Other | MIIT-LT |
Primary outcome
Cardiorespiratory Fitness (CRF)
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)
8 secondary outcomes
Metabolic Syndrome Z-Score (MetS-Z-Score)
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
Body Composition
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
Insulin sensitivity
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
Inflammation
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
Health-related quality of life
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
Pain scores
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
Perceived stress
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
Subjective work ability
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
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 14 Sep 2020.
- Derived from this study: PubMed 33160382Reljic D, Frenk F, Herrmann HJ, Neurath MF, Zopf Y. Low-volume high-intensity interval training improves cardiometabolic health, work ability and well-being in severely obese individuals: a randomized-controlled trial sub-study. J Transl Med. 2020 Nov 7;18(1):419. doi: 10.1186/s12967-020-02592-6.
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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.
Dejan Reljic, Dr. principal investigator
University Erlangen Nuremberg Medical School
Yurdaguel Zopf, Prof. principal investigator
University Erlangen Nuremberg Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT, MIIT-HR and MIIT-LT in people with Overweight and Obesity and Metabolic Syndrome, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 2 inclusion and 9 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 14 Sep 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 Germany. 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?
Cardiorespiratory Fitness (CRF) (time frame: 12 weeks (baseline to 12 week follow-up assessment)). 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 NCT03306069, which also lists 1 linked publication.
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 14 Sep 2020.