Physical ActivityOSPAANCT06784804
Comparing Objective and Subjective Physical Activity Assessments in Obese Patients
An observational study of Physical Activity and Anorexia Nervosa, run by Paracelsus Medical University at 1 site in Austria.
Trial summary
The goal of this observational study is to analyze the validity of self-reported physical activities in obese patients with psychosomatic disorders in a clinical setting. The main question aims to answer: How valid are self-reported physical activity data (via the International Physical Activity Questionnaire… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Activity, Anorexia Nervosa, Bulimia Nervosa
- How many people
- 23 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2020to 30 Mar 2022
- Phase
- Observational
- 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
Study population: 23 patients at the Psychosomatic Clinic in Eggenburg (Austria) from May 2020 to March 2022 were recruited. Patients received standardized instructions about the study's purpose and the use of the SWA and IPAQ-SF. During the first two weeks, they followed standard clinic therapies, including exercise. Body fat was measured before activity monitoring began. The SWA was provided during week three or four, with instructions on use and activity logging. Patients also completed the IPAQ-SF for the prior week. They were advised to maintain normal activity patterns and record non-wearing periods. Blinding was not feasible. Patients provided written informed consent to participate and for the use of their data in research. The patients were informed in detail about the study procedures. Participants took part in the study voluntarily and had the option of withdrawing at any time. Their privacy and rights were carefully protected throughout the study..
Who may be able to join
- ≥ 18 years old
- body mass index (BMI) ≥ 30
- could read and speak German
- had a diagnosis of an eating disorder (ICD-10: F50.9 unspecified eating disorder, F50.2 bulimia nervosa)
- had a clinical stay of at least 4 weeks
- wore the SWA for at least 18 h·d-1, (41) including at least 4 days with one weekend day
Who cannot join
- inability to walk independently
- a nickel allergy
- valid wearing time of accelerometer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Objective vs. Subjective Physical Activity Assessment in a Clinical Setting of Patients With Obesity and Comorbid Eating Disorders
The goal of this observational study is to analyze the validity of self-reported physical activities in obese patients with psychosomatic disorders in a clinical setting. The main question aims to answer:
- How valid are self-reported physical activity data (via the International Physical Activity Questionnaire, IPAQ-SF) compared to actigraphy-based objective measurements (using the SenseWear® armband, SWA)?
Read more
Between 2020 and 2022, 23 patients with obesity (21 anorexia nervosa, 2 bulimia nervosa) were recruited from an Austrian psychosomatic clinic. Receiving routine care, participants were additionally asked to
- wear the SWA for seven days in the clinic
- complete the IPAQ-SF for the same reference period on the first weekday after SWA wearing time
The study then statistically compared total physical activity, measured in so called metabolic equivalents (MET minutes per week), and sitting time (minutes per day) between the two methods to determine the accuracy of the self-reported data.
Read the detailed description
This methodological study presents the effort of a collaboration between the Department of Sport and Exercise Science (Paris Lodron University, Salzburg), the Psychosomatic Clinic Eggenburg (Eggenburg, Lower Austria, Austria), and the Paracelsus Medical University (Salzburg, Austria). The empirical work was done by a Master Student as part of a scientific qualification work (M.A. Sports Physiotherapy MSc) and supervised by a member of the research team.
Rationale of the Study:
Accurate measurement of physical activity is essential for addressing obesity, treating eating disorders, and combating the broader obesity epidemic. However, effective treatment requires accurate activity assessments. Traditional self-reported questionnaires often fail to provide this accuracy, particularly in populations where physical or psychological factors impair recall accuracy.
For patients treated for obesity and psychosomatic eating disorders, recall impairments are likely further exacerbated by distorted perceptions of normal physical activity, as well as stress, shame, stigmatization, and guilt.
Moreover, we expect the extent of inaccuracy in self-reported activity duration, frequency or intensity to depend on the actual magnitude of activity.
No previous study has focused on this population or used concurrent validity analysis to compare subjective vs objective measures of physical activity while addressing potential proportional bias adequately.
Hence, valid measurement of physical activity is crucial for treating obesity, eating disorders, and combating the obesity epidemic.
In this methodological study, the investigators assess the concurrent validity of self-reported questionnaires and actigraph-based objective measurements of physical activity in patients with obesity and psychosomatic eating disorders in a clinical setting. As a secondary aim, this research will evaluate potential moderator effects of obesity level and sex. Given its role as an objective measure, the sensor-based actigraph was used as a criterion to validate the IPAQ. The investigators hypothesize that subjective self-reports from the IPAQ will overestimate total physical activity, but underestimate sitting time compared to objective actigraph data.
Applied methods:
A concurrent validity study was conducted at the Psychosomatic Clinic in Eggenburg (Austria) from May 2020 to March 2022. In total, 23 obese patients (17 female, 6 male; 42 ± 14 years; BMI 41 ± 6 kg·m-2, 21 diagnosed with anorexia nervosa (ICD-10: F50.9), 2 with bulimia nervosa (ICD-10: F50.2), were recruited from an Austrian psychosomatic clinic. Patients admitted during the study period were eligible if they were ≥ 18 years old, had a body mass index (BMI) ≥ 30, could read and speak German, had a diagnosis of an eating disorder (ICD-10: F50.9 unspecified eating disorder, F50.2 bulimia nervosa), had a clinical stay of at least 4 weeks, and wore the SWA for at least 18 h·d-1, (41) including at least 4 days with one weekend day.
Patients self-administered the International Physical Activity Questionnaire (IPAQ-SF) while wearing the SenseWear® armband (SWA) for 7 days during the 3rd to 4th week of their clinical stay. Outcome measures included total physical activity, assessed using metabolic equivalents (MET min·w-1) and sitting time (min·d-1).
Concurrent validity - SWA as a criterion - was assessed using regression analyses, and proportional bias was examined through regression and equality line similarity analyses.
Expected benefits:
Valid information about physical activity is key for treating adults with obesity and psychosomatic disorders. The study will add further evidence to the of validity of self-reported physical activity. For the first time, concurrent validity of the specific population of obese patients is studied. The study results will help to better and more precise measure and estimate physical activity in obese patients. This will be crucial to informing intervention and treatment programs in practice as well as shed further light on how to measure the patient reported activity level in the most accurate and valid way.
- Conditions
- Physical Activity, Anorexia Nervosa, Bulimia Nervosa, Obesity
- Keywords
- Concurrent validity, SenseWear Actigraph, IPAQ-SF, Exercise therapy, Obesity, Self-report bias
- Medical subject headings
- Motor Activity, Anorexia Nervosa, Bulimia Nervosa, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese patients with anorexia nervosa or bulimia nervosa | Patients admitted during the study period were eligible if they were ≥ 18 years old, had a body mass index (BMI) ≥ 30, could read and speak German, had a diagnosis of an eating disorder (ICD-10: F50.9 unspecified eating disorder, F50.2 bulimia nervosa), had a clinical stay of at least 4 weeks, and wore the SWA for at least 18 h·d-1, including at least 4 days with one weekend day. Participant characteristics were as follows: Sex (f/m) 23 (17/6) Age (f/m) 42.1 ± 13.6 BMI (kg·m-2) 40,5 ± 5.7 Body fat (%) 43.5 ± 6.8 Sleep efficiency 81 ± 8 SWA wearing time 1400 ± 43 Activity in min (>3 MET) 94 ± 37 Steps 9935 ± 3050 Clinical stay (d) 61 ± 16 Eating disorders Eating disorder, F50.9 (%) 91 Bulimia nervosa, F50.2 (%) 9 Psychosomatic disorders Depression, F33 (%) 26 Personality disorders, F60 (%) 17 Neurotic disorders, F4 (%) 30 Bipolar disorders F31 (%) 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MET (Metabolic equivalents) - Objective measure of physical activity in MET min/week (by SWA)
The lightweight (83 g) SenseWear® Armband Pro 3 (Bodymedia, Inc., Pittsburgh, PA, USA) is a multisensory device that includes a two-axis accelerometer, as well as sensors to measure galvanic skin responses, skin and ambient temperature or heat flux. The monitor was initialized based patient's gender, age, weight and height, and was adjusted to fit on the triceps muscle, halfway between the acromion and olecranon processes of the dominant arm. A proprietary algorithm converts raw data into estimates of total and active energy expenditure, resting metabolic rate, metabolic units, total number of steps, duration of physical activity, duration of sleep and resting time. Data are expressed both in kcal·min-1 and metabolic equivalents (METs). The time of physical activity is categorized into different ranges based on the metabolic equivalent (MET). Values <3 MET are classified as low, METs between 3 and 6 as moderate values ≥6 MET as vigorous activity.
Measured: Period: SWA was worn for at least four days within week 3 or week 4 of clinical stay
MET (Metabolic equivalent) - Subjective measure of physical activity in MET min/week (by IPAQ self-report)
The International Physical Activity Questionnaire Short Form (IPAQ-SF) provides a standardized measure of physical activity for individuals across different populations. The most used short form consists of seven items that assess physical activity (frequency, duration) over the past seven days, categorizing it into four types: vigorous intensity, moderate intensity, walking, and sitting. An average metabolic equivalents score (MET, min·w-1) was calculated to assess total physical activity as well as for each type of activity, separately. For walking activities, all types of walking were included and an average MET score was derived. The same procedure was carried out for medium intensity and high intensity activities. By calculating the number of activity days multiplied by the average duration per activity, statements about the energy consumption per week and the fitness level can be derived. The last seven days in which the SWA was worn were used as the reference period.
Measured: Single time point: Retrospective self-report on the first weekday after SWA wearing time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 May 2020
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paracelsus Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Kutschar, Paracelsus Medical University
- Investigators
- Hans-Peter Wiesinger, PhD, Principal investigator, Paracelsus Medical UniversityElmar Kaiser, Dr. med., Chief physician, Principal investigator, Psychosomatic Clinic EggenburgBettina Bannert, MA, Principal investigator, Psychosomatic Clinic Eggenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784804
- Sponsor's protocol ID
- OSPAA-Obesity
- Acronym
- OSPAA
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective vs. Subjective Physical Activity Assessment in a Clinical Setting of Patients With Obesity and Comorbid Eating Disorders
- ClinicalTrials.gov ID
- NCT06784804
- Acronym / sponsor ID
- OSPAA / OSPAA-Obesity
- Conditions
- Physical Activity, Anorexia Nervosa, Bulimia Nervosa, Obesity
- Keywords
- Concurrent validity, SenseWear Actigraph, IPAQ-SF, Exercise therapy, Obesity, Self-report bias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Paracelsus Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 20 Jan 2025 (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 goal of this observational study is to analyze the validity of self-reported physical activities in obese patients with psychosomatic disorders in a clinical setting. The main question aims to answer:
- How valid are self-reported physical activity data (via the International Physical Activity Questionnaire, IPAQ-SF) compared to actigraphy-based objective measurements (using the SenseWear® armband, SWA)?
Between 2020 and 2022, 23 patients with obesity (21 anorexia nervosa, 2 bulimia nervosa) were recruited from an Austrian psychosomatic clinic. Receiving routine care, participants were additionally asked to
- wear the SWA for seven days in the clinic
- complete the IPAQ-SF for the same reference period on the first weekday after SWA wearing time
The study then statistically compared total physical activity, measured in so called metabolic equivalents (MET minutes per week), and sitting time (minutes per day) between the two methods to determine the accuracy of the self-reported data.
Detailed description
This methodological study presents the effort of a collaboration between the Department of Sport and Exercise Science (Paris Lodron University, Salzburg), the Psychosomatic Clinic Eggenburg (Eggenburg, Lower Austria, Austria), and the Paracelsus Medical University (Salzburg, Austria). The empirical work was done by a Master Student as part of a scientific qualification work (M.A. Sports Physiotherapy MSc) and supervised by a member of the research team.
Rationale of the Study:
Accurate measurement of physical activity is essential for addressing obesity, treating eating disorders, and combating the broader obesity epidemic. However, effective treatment requires accurate activity assessments. Traditional self-reported questionnaires often fail to provide this accuracy, particularly in populations where physical or psychological factors impair recall accuracy.
For patients treated for obesity and psychosomatic eating disorders, recall impairments are likely further exacerbated by distorted perceptions of normal physical activity, as well as stress, shame, stigmatization, and guilt.
Moreover, we expect the extent of inaccuracy in self-reported activity duration, frequency or intensity to depend on the actual magnitude of activity.
No previous study has focused on this population or used concurrent validity analysis to compare subjective vs objective measures of physical activity while addressing potential proportional bias adequately.
Hence, valid measurement of physical activity is crucial for treating obesity, eating disorders, and combating the obesity epidemic.
In this methodological study, the investigators assess the concurrent validity of self-reported questionnaires and actigraph-based objective measurements of physical activity in patients with obesity and psychosomatic eating disorders in a clinical setting. As a secondary aim, this research will evaluate potential moderator effects of obesity level and sex. Given its role as an objective measure, the sensor-based actigraph was used as a criterion to validate the IPAQ. The investigators hypothesize that subjective self-reports from the IPAQ will overestimate total physical activity, but underestimate sitting time compared to objective actigraph data.
Applied methods:
A concurrent validity study was conducted at the Psychosomatic Clinic in Eggenburg (Austria) from May 2020 to March 2022. In total, 23 obese patients (17 female, 6 male; 42 ± 14 years; BMI 41 ± 6 kg·m-2, 21 diagnosed with anorexia nervosa (ICD-10: F50.9), 2 with bulimia nervosa (ICD-10: F50.2), were recruited from an Austrian psychosomatic clinic. Patients admitted during the study period were eligible if they were ≥ 18 years old, had a body mass index (BMI) ≥ 30, could read and speak German, had a diagnosis of an eating disorder (ICD-10: F50.9 unspecified eating disorder, F50.2 bulimia nervosa), had a clinical stay of at least 4 weeks, and wore the SWA for at least 18 h·d-1, (41) including at least 4 days with one weekend day.
Patients self-administered the International Physical Activity Questionnaire (IPAQ-SF) while wearing the SenseWear® armband (SWA) for 7 days during the 3rd to 4th week of their clinical stay. Outcome measures included total physical activity, assessed using metabolic equivalents (MET min·w-1) and sitting time (min·d-1).
Concurrent validity - SWA as a criterion - was assessed using regression analyses, and proportional bias was examined through regression and equality line similarity analyses.
Expected benefits:
Valid information about physical activity is key for treating adults with obesity and psychosomatic disorders. The study will add further evidence to the of validity of self-reported physical activity. For the first time, concurrent validity of the specific population of obese patients is studied. The study results will help to better and more precise measure and estimate physical activity in obese patients. This will be crucial to informing intervention and treatment programs in practice as well as shed further light on how to measure the patient reported activity level in the most accurate and valid way.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese patients with anorexia nervosa or bulimia nervosa | – | –Patients admitted during the study period were eligible if they were ≥ 18 years old, had a body mass index (BMI) ≥ 30, could read and speak German, had a diagnosis of an eating disorder (ICD-10: F50.9 unspecified eating disorder, F50.2 bulimia nervosa), had a clinical stay of at least 4 weeks, and wore the SWA for at least 18 h·d-1, including at least 4 days with one weekend day. Participant characteristics were as follows: Sex (f/m) 23 (17/6) Age (f/m) 42.1 ± 13.6 BMI (kg·m-2) 40,5 ± 5.7 Body fat (%) 43.5 ± 6.8 Sleep efficiency 81 ± 8 SWA wearing time 1400 ± 43 Activity in min (>3 MET) 94 ± 37 Steps 9935 ± 3050 Clinical stay (d) 61 ± 16 Eating disorders Eating disorder, F50.9 (%) 91 Bulimia nervosa, F50.2 (%) 9 Psychosomatic disorders Depression, F33 (%) 26 Personality disorders, F60 (%) 17 Neurotic disorders, F4 (%) 30 Bipolar disorders F31 (%) 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 23 patients at the Psychosomatic Clinic in Eggenburg (Austria) from May 2020 to March 2022 were recruited. Patients received standardized instructions about the study's purpose and the use of the SWA and IPAQ-SF. During the first two weeks, they followed standard clinic therapies, including exercise. Body fat was measured before activity monitoring began. The SWA was provided during week three or four, with instructions on use and activity logging. Patients also completed the IPAQ-SF for the prior week. They were advised to maintain normal activity patterns and record non-wearing periods. Blinding was not feasible. Patients provided written informed consent to participate and for the use of their data in research. The patients were informed in detail about the study procedures. Participants took part in the study voluntarily and had the option of withdrawing at any time. Their privacy and rights were carefully protected throughout the study..
Key inclusion criteria (6 listed)
- ≥ 18 years old
- body mass index (BMI) ≥ 30
- could read and speak German
- had a diagnosis of an eating disorder (ICD-10: F50.9 unspecified eating disorder, F50.2 bulimia nervosa)
- had a clinical stay of at least 4 weeks
Key exclusion criteria (3 listed)
- inability to walk independently
- a nickel allergy
- valid wearing time of accelerometer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MET (Metabolic equivalents) - Objective measure of physical activity in MET min/week (by SWA)
Time frame: Period: SWA was worn for at least four days within week 3 or week 4 of clinical stay
The lightweight (83 g) SenseWear® Armband Pro 3 (Bodymedia, Inc., Pittsburgh, PA, USA) is a multisensory device that includes a two-axis accelerometer, as well as sensors to measure galvanic skin responses, skin and ambient temperature or heat flux. The monitor was initialized based patient's gender, age, weight and height, and was adjusted to fit on the triceps muscle, halfway between the acromion and olecranon processes of the dominant arm. A proprietary algorithm converts raw data into estimates of total and active energy expenditure, resting metabolic rate, metabolic units, total number of steps, duration of physical activity, duration of sleep and resting time. Data are expressed both in kcal·min-1 and metabolic equivalents (METs). The time of physical activity is categorized into different ranges based on the metabolic equivalent (MET). Values <3 MET are classified as low, METs between 3 and 6 as moderate values ≥6 MET as vigorous activity.
MET (Metabolic equivalent) - Subjective measure of physical activity in MET min/week (by IPAQ self-report)
Time frame: Single time point: Retrospective self-report on the first weekday after SWA wearing time
The International Physical Activity Questionnaire Short Form (IPAQ-SF) provides a standardized measure of physical activity for individuals across different populations. The most used short form consists of seven items that assess physical activity (frequency, duration) over the past seven days, categorizing it into four types: vigorous intensity, moderate intensity, walking, and sitting. An average metabolic equivalents score (MET, min·w-1) was calculated to assess total physical activity as well as for each type of activity, separately. For walking activities, all types of walking were included and an average MET score was derived. The same procedure was carried out for medium intensity and high intensity activities. By calculating the number of activity days multiplied by the average duration per activity, statements about the energy consumption per week and the fitness level can be derived. The last seven days in which the SWA was worn were used as the reference period.
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 24 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Hans-Peter Wiesinger, PhD principal investigator
Paracelsus Medical University
Elmar Kaiser, Dr. med., Chief physician principal investigator
Psychosomatic Clinic Eggenburg
Bettina Bannert, MA principal investigator
Psychosomatic Clinic Eggenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Activity and Anorexia Nervosa, run by Paracelsus Medical University at 1 site in Austria.
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 6 inclusion and 3 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 24 Jan 2025. 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 Austria. 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?
MET (Metabolic equivalents) - Objective measure of physical activity in MET min/week (by SWA) (time frame: Period: SWA was worn for at least four days within week 3 or week 4 of clinical stay). 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 24 Jan 2025.