Overweight and ObesityNCT03173755
Pain Discomfort Enjoyment Levels During Moderate Exercise
An observational study of Overweight and Obesity, run by Texas Tech University at 1 site in United States.
Trial summary
In order to better understand how pre-existing pain and also discomfort/enjoyment during exercise may influence physical activity and be related to body weight the investigators are seeking to examine these as they relate to overweight/obesity compared to normal weight individuals. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Overweight and Obesity
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2017to 31 May 2019
- 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 to 60 years
- All sexes
- Adult
Study population: The study will recruit participants from Lubbock Texas Community and surrounding regions.
Who may be able to join
- Age: 18-60 years.
- BMI ≥ 18.5 kg/m2.
- Typically exercise (moderate-intensity aerobic exercise - e.g. brisk walking) less than 150 minutes per week (last 3 months)
- No known contraindications for participating in up to 42 minutes of moderate intensity physical activity.
- Have not been told by a qualified healthcare provider to avoid moderate physical activity.
Who cannot join
- Unable/unwilling to provide informed consent.
- Having motor impairment.
- Currently diagnosed with diabetes mellitus, experiencing uncontrolled hypertension (i.e. systolic blood pressure (SBP) > 140 mmHg or diastolic blood pressure (DBP) > 90 mmHg), having a history of ischemic heart disease, cerebrovascular accidents, neurological disease or current/past severe psychiatric illness (e.g. severe depression, psychosis, schizophrenia) that required hospitalization, severe current untreated depression (i.e. score in the severe depression range on the Hospital Anxiety and Depression Scale; HADS), current suicidal ideation, and current or past suicide attempts.
- Women who are pregnant or nursing.
- Diagnosed history of eating disorders such as bulimia nervosa, anorexia nervosa.
- Diagnosed history of substance abuse or alcohol abuse.
Show all 11Show fewer
- Currently undergoing pain management treatment (pharmacologic and or behavioral).
- Currently taking anti-depressant medicines
- Have been instructed by a qualified healthcare provider to refrain from moderate physical activity at any time during the last 12 months (reasons other than minor orthopedic injury etc.).
- Any implanted medical devices (e.g. pacemaker).
- Currently smoking (within last 12 months).
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University - Department of Nutritional Sciences
Lubbock, Texas, 79409
About this study
Official title: Relationships of Pain, Discomfort and Enjoyment During Exercise to Weight Status and Diet Quality.
In order to better understand how pre-existing pain and also discomfort/enjoyment during exercise may influence physical activity and be related to body weight the investigators are seeking to examine these as they relate to overweight/obesity compared to normal weight individuals. Ultimately, the investigators think that people with obesity may have more and be more sensitive to pain and have lower discomfort tolerance that may lead them to experience exercise more negatively. In the real world, this could result in them stopping exercise sooner or avoiding exercise all together. Therefore it is important for the investigators to begin to understand this issue better. In addition, some preliminary studies in animals suggest that the quality of the diet may influence pain sensitivity. This has yet to be examined in humans. As such the investigators will examine whether self-reported diet quality and also some markers in participants' blood that can tell the investigators about the recent quality of a person's diet, are related to the measures of pain, enjoyment and discomfort during exercise.
- Conditions
- Overweight and Obesity
- Medical subject headings
- Overweight, 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 |
|---|---|---|
| People with normal weight | Not described | |
| people with overweight and obesity | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of self-report measurement of pain (Short Form McGill Pain Questionnaire) according to BMI.
Comparison of self-report measurement of pain (Short Form McGill Pain Questionnaire) according to BMI (weight and height will be combined to report BMI in kg/m2).
Measured: Baseline
Comparison of self-report measurement of pain (Subjective Pain Rating Scale) according to BMI.
Comparison of self-report measurement of pain (Subjective Pain Rating Scale) according to BMI (weight and height will be combined to report BMI in kg/m2).
Measured: Baseline
Comparison of physical activity-induced pain (Subjective Pain Rating Scale) according to BMI.
Comparison of physical activity-induced pain (Subjective Pain Rating Scale) according to BMI (weight and height will be combined to report BMI in kg/m2).
Measured: minute zero through minute 42 of single exercise testing session (pre- post- session)
Secondary outcomes (3)
Comparison of self-report measurement of pain (Short Form McGill Pain Questionnaire) according to diet quality index.
Comparison of self-report measurement of pain (Short Form McGill Pain Questionnaire) according to diet quality index (DQI; is a factor analytically derived composite score of 5 nutritional quality biomarkers <plasma alkylresorcinol, Omega-3 index, serum fatty acid composition, serum carotenoids, and serum selenium>.)
Measured: Baseline
Comparison of self-report measurement of pain (Subjective Pain Rating Scale) according to diet quality index.
Comparison of self-report measurement of pain (Subjective Pain Rating Scale) according to diet quality index (DQI is a factor analytically derived composite score of 5 nutritional quality biomarkers < plasma alkylresorcinol, Omega-3 index, serum fatty acid composition, serum carotenoids, and serum selenium>.)
Measured: Baseline
Comparison of objectively measured pain tolerance (Dolorimetry) according to BMI.
Comparison of objectively measured pain tolerance (Dolorimetry) according to BMI (weight and height will be combined to report BMI in kg/m2).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start29 Aug 2017
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Binks, Texas Tech University
- Investigators
- Martin Binks, PhD, Principal investigator, Texas Tech University - Department of Nutritional Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173755
- Sponsor's protocol ID
- TTUIRB2017-247
- Status last verified
- Sep 2019
- First submitted
- 26 May 2017
- Last updated
- 30 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships of Pain, Discomfort and Enjoyment During Exercise to Weight Status and Diet Quality.
- ClinicalTrials.gov ID
- NCT03173755
- Acronym / sponsor ID
- TTUIRB2017-247
- Conditions
- Overweight and Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 2 Jun 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.
In order to better understand how pre-existing pain and also discomfort/enjoyment during exercise may influence physical activity and be related to body weight the investigators are seeking to examine these as they relate to overweight/obesity compared to normal weight individuals. Ultimately, the investigators think that people with obesity may have more and be more sensitive to pain and have lower discomfort tolerance that may lead them to experience exercise more negatively. In the real world, this could result in them stopping exercise sooner or avoiding exercise all together. Therefore it is important for the investigators to begin to understand this issue better. In addition, some preliminary studies in animals suggest that the quality of the diet may influence pain sensitivity. This has yet to be examined in humans. As such the investigators will examine whether self-reported diet quality and also some markers in participants' blood that can tell the investigators about the recent quality of a person's diet, are related to the measures of pain, enjoyment and discomfort during exercise.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with normal weight | – | – |
| people with overweight and obesity | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- The study will recruit participants from Lubbock Texas Community and surrounding regions.
Key inclusion criteria (5 listed)
- Age: 18-60 years.
- BMI ≥ 18.5 kg/m2.
- Typically exercise (moderate-intensity aerobic exercise - e.g. brisk walking) less than 150 minutes per week (last 3 months)
- No known contraindications for participating in up to 42 minutes of moderate intensity physical activity.
- Have not been told by a qualified healthcare provider to avoid moderate physical activity.
Key exclusion criteria (11 listed)
- Unable/unwilling to provide informed consent.
- Having motor impairment.
- Currently diagnosed with diabetes mellitus, experiencing uncontrolled hypertension (i.e. systolic blood pressure (SBP) > 140 mmHg or diastolic blood pressure (DBP) > 90 mmHg), having a history of ischemic heart disease, cerebrovascular accidents, neurological disease or current/past severe psychiatric illness (e.g. severe depression, psychosis, schizophrenia) that required hospitalization, severe current untreated depression (i.e. score in the severe depression range on the Hospital Anxiety and Depression Scale; HADS), current suicidal ideation, and current or past suicide attempts.
- Women who are pregnant or nursing.
- Diagnosed history of eating disorders such as bulimia nervosa, anorexia nervosa.
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
Comparison of self-report measurement of pain (Short Form McGill Pain Questionnaire) according to BMI.
Time frame: Baseline
Comparison of self-report measurement of pain (Short Form McGill Pain Questionnaire) according to BMI (weight and height will be combined to report BMI in kg/m2).
Comparison of self-report measurement of pain (Subjective Pain Rating Scale) according to BMI.
Time frame: Baseline
Comparison of self-report measurement of pain (Subjective Pain Rating Scale) according to BMI (weight and height will be combined to report BMI in kg/m2).
Comparison of physical activity-induced pain (Subjective Pain Rating Scale) according to BMI.
Time frame: minute zero through minute 42 of single exercise testing session (pre- post- session)
Comparison of physical activity-induced pain (Subjective Pain Rating Scale) according to BMI (weight and height will be combined to report BMI in kg/m2).
3 secondary outcomes
Comparison of self-report measurement of pain (Short Form McGill Pain Questionnaire) according to diet quality index.
Time frame: Baseline
Comparison of self-report measurement of pain (Subjective Pain Rating Scale) according to diet quality index.
Time frame: Baseline
Comparison of objectively measured pain tolerance (Dolorimetry) according to BMI.
Time frame: Baseline
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 30 Sep 2019.
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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.
Martin Binks, PhD principal investigator
Texas Tech University - Department of Nutritional Sciences
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 Overweight and Obesity, run by Texas Tech University at 1 site in United States.
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 5 inclusion and 11 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 30 Sep 2019. 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 United States. 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?
Comparison of self-report measurement of pain (Short Form McGill Pain Questionnaire) according to BMI. (time frame: Baseline). The study lists 3 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 30 Sep 2019.