ObesitySTOPNCT02100995
Simultaneously Targeting Obesity and Pain: The STOP Trial
A study testing Intervention Simultaneously Targeting Obesity and Pain, Weight Loss/Weight Self-Management and Chronic Pain Self-Management in people with Obesity and Chronic Pain, run by University of the Sciences in Philadelphia at 1 site in United States.
Trial summary
The purpose of this study is to determine whether an integrated behavioral treatment approach can help overweight or obese individuals who also have chronic pain reduce their weight and manage their pain symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Chronic Pain
- What is being tested?
- Intervention Simultaneously Targeting Obesity and Pain, Weight Loss/Weight Self-Management and Chronic Pain Self-Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jan 2017
- 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
- Adults aged ≥ 18
- Body mass index (BMI) ≥ 25
- Chronic, non-cancer pain (pain at a level ≥ 4 on a scale of 0-10 on a majority of the days for 6 months or more prior to study participation)
Who cannot join
- Have an unstable medical or psychiatric condition
- Meet criteria for current substance abuse or dependence
- Meet the criteria for bulimia
- Non-fluent in spoken or written English
- Currently pregnant, pregnant within the past 6 months, trying to get pregnant in the next 3 months
- Demonstrate significant cognitive or sensorimotor impairment precluding treatment engagement
Show all 9Show fewer
- Already participating in a similar structured diet or exercise program or pain self-management program or plans to begin such a program outside the study during the next month
- At risk for significant adverse cardiovascular events with moderate activity
- Plans to relocate within the upcoming 12 months
Trial locations and contacts
1 site in 1 country.
Research Assistant(s) contact
United States1 site, 1 recruiting
- Recruiting
University of the Sciences
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Clinical Trial of an Integrated Behavioral Self-management Intervention Simultaneously Targeting Obesity and Pain: The STOP Trial
The purpose of this study is to determine whether an integrated behavioral treatment approach can help overweight or obese individuals who also have chronic pain reduce their weight and manage their pain symptoms. The goal of this research is to develop better treatments for individuals with chronic pain and overweight or obesity. All participants in this study will receive treatment for weight management and/or pain symptoms. Participants will be assigned at random (like we picked it blindly out of a hat) to receive either: (1) Standard behavioral treatment for weight loss; or (2) Standard behavioral treatment for pain management; or (3) Integrated behavioral treatment for weight loss and pain.
- Conditions
- Obesity, Chronic Pain
- Being tested
- Intervention Simultaneously Targeting Obesity and Pain, Weight Loss/Weight Self-Management, Chronic Pain Self-Management
- Medical subject headings
- Obesity, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Simultaneously Targeting Obesity and PainBehavioural
Weight Loss/Weight Self-ManagementBehavioural
Chronic Pain Self-ManagementBehavioural
| Study group | Role | What they receive |
|---|---|---|
| STOP Intervention | Experimental | The STOP treatment includes content designed to simultaneously and explicitly target both chronic pain and obesity. Treatment components are drawn from evidence-based interventions for chronic pain and obesity, separately. Receives: Behavioral: Intervention Simultaneously Targeting Obesity and Pain |
| Standard Care Weight (SCW) | Active comparator | The weight loss intervention includes content focused around nutrition and eating habits, stimulus control and behavioral change, and physical activity. This content has been chosen because of its demonstrated effectiveness and importance in behavioral interventions to reduce weight. Receives: Behavioral: Weight Loss/Weight Self-Management |
| Standard Care Pain (SCP) | Active comparator | The chronic pain intervention is focused around reconceptualization of pain, decreasing catastrophizing, and increasing self-efficacy for pain. This content has been chosen because of its demonstrated effectiveness and importance in non-pharmacological interventions to improve pain management. Receives: Behavioral: Chronic Pain Self-Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight from baseline to 12-months
Body weight measured using a calibrated digital scale during assessment visits.
Measured: Baseline, up to 12 months
Change in pain intensity from baseline to 12 months
Pain intensity as measured on a numeric ratings scale (NRS) of 0 (no pain) to 10 (worst pain imaginable).
Measured: Baseline, up to 12 months
Secondary outcomes (2)
Change in pain disability from baseline to 12 months
As measured by West Haven Yale Multidimensional Pain Inventory (WHYMPI).
Measured: Baseline, up to 12 months
Change in quality of life from baseline to 12 months
As measured by the SF-36.
Measured: Baseline, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Primary completionJan 2017 (estimated)
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of the Sciences in Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Amy Janke, University of the Sciences in Philadelphia
- Investigators
- Elizabeth A Janke, PhD, Principal investigator, University of the Sciences in Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100995
- Sponsor's protocol ID
- SAP# 4100057688
- Acronym
- STOP
- Status last verified
- Apr 2016
- First submitted
- 24 Mar 2014
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Janke EA, Fritz M, Hopkins C, Haltzman B, Sautter JM, Ramirez ML. A randomized clinical trial of an integrated behavioral self-management intervention Simultaneously Targeting Obesity and Pain: the STOP trial. BMC Public Health. 2014 Jun 18;14:621. doi: 10.1186/1471-2458-14-621.
PubMed 24943851
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of an Integrated Behavioral Self-management Intervention Simultaneously Targeting Obesity and Pain: The STOP Trial
- ClinicalTrials.gov ID
- NCT02100995
- Acronym / sponsor ID
- STOP / SAP# 4100057688
- Conditions
- Obesity, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University of the Sciences in PhiladelphiaUniversity, hospital or other
- Primary completion
- Jan 2017 (estimated)
- First posted
- 1 Apr 2014 (estimated)
- 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 purpose of this study is to determine whether an integrated behavioral treatment approach can help overweight or obese individuals who also have chronic pain reduce their weight and manage their pain symptoms. The goal of this research is to develop better treatments for individuals with chronic pain and overweight or obesity. All participants in this study will receive treatment for weight management and/or pain symptoms. Participants will be assigned at random (like we picked it blindly out of a hat) to receive either: (1) Standard behavioral treatment for weight loss; or (2) Standard behavioral treatment for pain management; or (3) Integrated behavioral treatment for weight loss and pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STOP Intervention | Experimental | Behavioral: Intervention Simultaneously Targeting Obesity and PainThe STOP treatment includes content designed to simultaneously and explicitly target both chronic pain and obesity. Treatment components are drawn from evidence-based interventions for chronic pain and obesity, separately. |
| Standard Care Weight (SCW) | Active comparator | Behavioral: Weight Loss/Weight Self-ManagementThe weight loss intervention includes content focused around nutrition and eating habits, stimulus control and behavioral change, and physical activity. This content has been chosen because of its demonstrated effectiveness and importance in behavioral interventions to reduce weight. |
| Standard Care Pain (SCP) | Active comparator | Behavioral: Chronic Pain Self-ManagementThe chronic pain intervention is focused around reconceptualization of pain, decreasing catastrophizing, and increasing self-efficacy for pain. This content has been chosen because of its demonstrated effectiveness and importance in non-pharmacological interventions to improve pain management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged ≥ 18
- Body mass index (BMI) ≥ 25
- Chronic, non-cancer pain (pain at a level ≥ 4 on a scale of 0-10 on a majority of the days for 6 months or more prior to study participation)
Key exclusion criteria (9 listed)
- Have an unstable medical or psychiatric condition
- Meet criteria for current substance abuse or dependence
- Meet the criteria for bulimia
- Non-fluent in spoken or written English
- Currently pregnant, pregnant within the past 6 months, trying to get pregnant in the next 3 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 |
|---|---|---|
| Intervention Simultaneously Targeting Obesity and Pain | Behavioural | STOP Intervention |
| Weight Loss/Weight Self-Management | Behavioural | Standard Care Weight (SCW) |
| Chronic Pain Self-Management | Behavioural | Standard Care Pain (SCP) |
Primary outcome
Change in weight from baseline to 12-months
Time frame: Baseline, up to 12 months
Body weight measured using a calibrated digital scale during assessment visits.
Change in pain intensity from baseline to 12 months
Time frame: Baseline, up to 12 months
Pain intensity as measured on a numeric ratings scale (NRS) of 0 (no pain) to 10 (worst pain imaginable).
2 secondary outcomes
Change in pain disability from baseline to 12 months
Time frame: Baseline, up to 12 months
Change in quality of life from baseline to 12 months
Time frame: Baseline, up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Derived from this study: PubMed 24943851Janke EA, Fritz M, Hopkins C, Haltzman B, Sautter JM, Ramirez ML. A randomized clinical trial of an integrated behavioral self-management intervention Simultaneously Targeting Obesity and Pain: the STOP trial. BMC Public Health. 2014 Jun 18;14:621. doi: 10.1186/1471-2458-14-621.
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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.
Research Assistant(s) contact
Elizabeth A Janke, PhD principal investigator
University of the Sciences in Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Simultaneously Targeting Obesity and Pain, Weight Loss/Weight Self-Management and Chronic Pain Self-Management in people with Obesity and Chronic Pain, run by University of the Sciences in Philadelphia 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 3 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: status not confirmed, as of the sponsor's last update on 15 Apr 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Madelyn Ruggieri (215-596-7185, hbrlab@usciences.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight from baseline to 12-months (time frame: Baseline, up to 12 months). 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?
On the ClinicalTrials.gov record for NCT02100995, 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 15 Apr 2016.