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Completed

NCT Number: NCT05379088

Activity Level Monitoring Study

The purpose of this study is to 1) evaluate the relationship of physical activity to quality of life and psychological functioning among adults with severe obesity (BMI>40) and 2) evaluate the effects of activity monitoring on changes in physical activity during a 6-week intervention interval.

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Key information

Conditions

Obesity Behavior Body Weight Morbid Obesity Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sedentary Behavior Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • BMI greater than or equal to 40
  • Sit or lie down greater than or equal to 9 hours per day

Exclusion criteria

  • Participating in regular exercise (any planned exercise)
  • Participating in a formal weight loss or exercise program
  • Planning to join a formal weight loss or exercise program in the next 2 months
  • Cannot stand up without assistance
  • Currently pregnant
  • Planning to get pregnant in the next 2 months
  • Given birth in past 9 months
  • Currently breast feeding
  • Weigh over 400 lbs
  • Highest level of education is below 8th grade
  • PHQ-9 score less than 15
  • Visual impairment that impairs ability to read
  • Any condition(s) that would make it challenging to follow instructions/directions
  • Cognitive disorder (e.g., dementia)

Treatment and study plan

Phone/zoom calls

Behavioral

Participants will complete weekly follow-up phone/zoom calls with a member of the research team. The phone/zoom calls will typically last 30-60 minutes. Participants will discuss barriers to activity and goals for upcoming weeks.

Primary outcomes

  1. Sedentary time

    Time frame: Change from baseline to 6 weeks

    Participants will wear activity monitors for the duration of the study. Sedentary time is operationalized as any recorded waking time spent sitting or lying down.

  2. Sit to stand transitions

    Time frame: Change from baseline to 6 weeks

    Participants will wear activity monitors for the duration of the study. The monitors will keep track of every time a participant goes from sitting to standing and vice versa.

  3. Self-report physical activity

    Time frame: Change from baseline to 6 weeks

    Participants will complete the Modified International Physical Activity Questionnaire - Short Form

  4. Physical function

    Time frame: Change from baseline to 6 weeks

    Participants will complete a 60-foot walk test and 30-second chair stand test.

  5. Health Related Quality of life

    Time frame: Change from baseline to 6 weeks

    Participants will complete the Medical Outcomes Survey, Short Form-36

Secondary outcomes

  1. Perceived stress

    Time frame: Change from baseline to 6 weeks

    Participants will complete the Perceived Stress Scale

  2. Psychological distress

    Time frame: Change from baseline to 6 weeks

    Participants will complete the Hospital and Anxiety Scale

  3. Insomnia

    Time frame: Change from baseline to 6 weeks

    Participants will complete the Insomnia Severity Index

  4. Sleep quality

    Time frame: Change from baseline to 6 weeks

    Participants will complete the Pittsburgh Sleep Quality Index

  5. Pain perception measure 1

    Time frame: Change from baseline to 6 weeks

    Participants will complete the McGill Pain Questionnaire

  6. Pain perception measure 2

    Time frame: Change from baseline to 6 weeks

    Participants will complete the Visual Analog Scale for Pain

  7. Weight Stigma measure 1

    Time frame: Change from baseline to 6 weeks

    Participants will complete the Stigma Situations Inventory

  8. Weight Stigma measure 2

    Time frame: Change from baseline to 6 weeks

    Participants will complete the Weight Bias Internalization Scale

  9. Weight Stigma measure 3

    Time frame: Change from baseline to 6 weeks

    Participants will complete the Body Appreciation Scale

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Acronym: ALMS

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 18, 2022
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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