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Partnership Optimizes Weight Management in Primary Care (PROMISE)

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ClinicalTrials.gov Identifier: NCT02959021
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Gareth R. Dutton PhD, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE November 4, 2016
First Posted Date  ICMJE November 8, 2016
Last Update Posted Date May 22, 2019
Actual Study Start Date  ICMJE January 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2016)
body weight [ Time Frame: 6, 12, and 18 months ]
change in body weight (kg) from baseline to follow-up assessments
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02959021 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2016)
  • physical activity [ Time Frame: 6, 12, and 18 months ]
    Self-reported physical activity assessed via the Paffenbarger Physical Activity Questionnaire (PPAQ).
  • treatment adherence [ Time Frame: 6, 12, and 18 months ]
    Treatment adherence will be assessed by the number of treatment sessions and phone calls completed.
  • treatment burden [ Time Frame: 6, 12, and 18 months ]
    Behavioral burden of treatment will be assessed with self-report questionnaires including items about the perceived burden of behavioral targets such as self-monitoring, dietary changes, maintaining physical activity, and the impact of treatment on social relationships.
  • treatment satisfaction [ Time Frame: 6, 12, and 18 months ]
    Participants will complete self-report items assessing their attitudes and satisfaction regarding the weight loss intervention and weight loss achieved.
  • side effects [ Time Frame: 6, 12, and 18 months ]
    Symptom checklist including minor (e.g., constipation, dry mouth) and more severe events (e.g., cardiovascular events) will be administered to assess potential adverse side effects associated with treatment.
  • quality of life [ Time Frame: 6, 12, and 18 months ]
    Quality of life will be assessed through the validated Short-Form 12 (SF-12), which provides measures of health-related quality of life for physical and mental health.
  • physical and social functioning [ Time Frame: 6, 12, and 18 months ]
    Items from the Patient Reported Outcome Measurement Information System (PROMIS) will be administered, including the 8-item short forms for physical and social functioning.
  • mood [ Time Frame: 6, 12, and 18 months ]
    The Patient Health Questionnaire-8 (PHQ-8), a validated self-report measure of depressive symptoms experienced over the past two weeks, will be administered.
  • healthcare utilization [ Time Frame: 6, 12, and 18 months ]
    Self-reported utilization of health care services (hospitalizations, ER/physician office visits, prescription drugs, etc.) and out-of-pocket costs will be collected.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Partnership Optimizes Weight Management in Primary Care
Official Title  ICMJE Primary Care Obesity Management in the Southeast_PROMISE
Brief Summary The purpose of this study is to examine whether a primary care weight management intervention delivered by peer coaches produces greater weight loss than a self-directed program without peer coach support.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Behavioral: weight loss intervention - self directed
  • Behavioral: weight loss intervention - peer coach
Study Arms  ICMJE
  • Active Comparator: Self-directed treatment
    Participants randomly assigned to this arm will receive written and pre-recorded behavioral weight loss intervention materials (i.e., DVDs, online videos), and they will be instructed to work through the materials independently at their own pace. They will have continued physician contact as needed for routine medical care.
    Intervention: Behavioral: weight loss intervention - self directed
  • Experimental: Peer coach treatment
    Participants randomly assigned to this arm will receive a combination of in-person, group-based behavioral weight loss sessions plus individual, telephone contacts. Groups and phone calls will be facilitated by a peer coach interventionist. Similar to the self-directed condition, participants will receive written and pre-recorded intervention materials (i.e., DVDs, online videos). They will also have continued contact with their physician for routine medical care.
    Intervention: Behavioral: weight loss intervention - peer coach
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2016)
375
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 21-75 years
  • Body mass index (BMI) 30-50 kg/m2
  • Receiving primary care services at one of the practices participating in this study

Exclusion Criteria:

  • Uncontrolled hypertension (blood pressure >160/100 mm Hg at screening)
  • Any of the following other medical conditions: myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; NYHA Class III or IV congestive heart failure; type 1 diabetes; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); and chronic lung diseases that limit physical activity
  • Current use of any of the following medications: antipsychotic agents, monoamine oxidase inhibitors, systemic corticosteroids, or chemotherapeutic drugs; prescription weight loss medications (past six months)
  • Unwilling or unable to do any of the following: give informed consent; read/understand English; accept random assignment; travel to the intervention site
  • Likely to relocate out of the area in the next 2 years
  • Participation in another randomized research project
  • Weight loss > 10 pounds in past six months
  • History of bariatric surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Janice Phillips 205-975-7914 jmphillips@uabmc.edu
Contact: Renae Glover 205-996-2875 rglover@uabmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02959021
Other Study ID Numbers  ICMJE NIH R01DK106041
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: With the documented permission of the IRB, the PI may develop a transportable de-identified database, codebook, and mechanism by which data can be shared with qualified investigators. Interested investigators will be asked to complete a standardized request form stating the specific aims of the analyses, the analytic plan, available resources for completing the proposed project, proposed timeline, and goals (i.e., manuscripts, presentations, and/or grant applications). The PI and research team will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to complete the request, and whether data will be adequately protected and managed. If any of these issues are problematic, the PI and research team will attempt to negotiate a fair resolution with the interested investigators and NIH program staff.
Responsible Party Gareth R. Dutton PhD, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gareth Dutton, PhD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP