Comparing Objective and Subjective Physical Activity Assessments in Obese Patients

NCT06784804 | Completed

• 1 other identifier: OSPAA-Obesity
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Physical Activity; Anorexia Nervosa; Bulimia Nervosa; Obesity

Keywords

Concurrent validity; SenseWear Actigraph; IPAQ-SF; Exercise therapy; Obesity; Self-report bias

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Single time point: Retrospective self-report on the first weekday after SWA wearing time

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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..

You may qualify if:

• ≥ 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

You may not qualify if:

• inability to walk independently
• a nickel allergy
• valid wearing time of accelerometer

Sponsors & Collaborators

• Paracelsus Medical University: lead

Study Sites (1)

Psychosomatic Clinic Eggenburg

Eggenburg, Lower Austria, 3730, Austria

Location

MeSH Terms

Conditions

Motor Activity; Anorexia Nervosa; Bulimia Nervosa; Obesity

Condition Hierarchy (Ancestors)

Behavior; Feeding and Eating Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hans-Peter Wiesinger, PhD

  Paracelsus Medical University

  PRINCIPAL INVESTIGATOR

• Elmar Kaiser, Dr. med., Chief physician

  Psychosomatic Clinic Eggenburg

  PRINCIPAL INVESTIGATOR

• Bettina Bannert, MA

  Psychosomatic Clinic Eggenburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof. Mag. Dr. Patrick Kutschar

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 20, 2025
• Study Start: May 1, 2020
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

AU (1)