Simultaneously Targeting Obesity and Pain: The STOP Trial

NCT ID: NCT02100995

Last Updated: 2016-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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STOP Intervention

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.

Group Type EXPERIMENTAL

Intervention Simultaneously Targeting Obesity and Pain

Intervention Type BEHAVIORAL

Standard Care Weight (SCW)

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.

Group Type ACTIVE_COMPARATOR

Weight Loss/Weight Self-Management

Intervention Type BEHAVIORAL

Standard Care Pain (SCP)

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.

Group Type ACTIVE_COMPARATOR

Chronic Pain Self-Management

Intervention Type BEHAVIORAL

Interventions

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Intervention Simultaneously Targeting Obesity and Pain

Intervention Type BEHAVIORAL

Weight Loss/Weight Self-Management

Intervention Type BEHAVIORAL

Chronic Pain Self-Management

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of the Sciences in Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Amy Janke

Assistant Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth A Janke, PhD

Role: PRINCIPAL_INVESTIGATOR

University of the Sciences in Philadelphia

Locations

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University of the Sciences

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Madelyn Ruggieri

Role: CONTACT

215-596-7185

Research Assistant(s)

Role: CONTACT

References

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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.

Reference Type DERIVED
PMID: 24943851 (View on PubMed)

Other Identifiers

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SAP# 4100057688

Identifier Type: -

Identifier Source: org_study_id

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