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Trial record 9 of 491 for:    PROMISE

Partnership Optimizes Weight Management in Primary Care (PROMISE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2016 by University of Alabama at Birmingham
Sponsor:
Information provided by (Responsible Party):
Gareth R. Dutton PhD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT02959021
First received: November 4, 2016
Last updated: NA
Last verified: November 2016
History: No changes posted
  Purpose
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.

Condition Intervention
Obesity
Behavioral: weight loss intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Primary Care Obesity Management in the Southeast_PROMISE

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • body weight [ Time Frame: 6, 12, and 18 months ] [ Designated as safety issue: No ]
    change in body weight (kg) from baseline to follow-up assessments


Secondary Outcome Measures:
  • physical activity [ Time Frame: 6, 12, and 18 months ] [ Designated as safety issue: No ]
    Self-reported physical activity assessed via the Paffenbarger Physical Activity Questionnaire (PPAQ).

  • treatment adherence [ Time Frame: 6, 12, and 18 months ] [ Designated as safety issue: No ]
    Treatment adherence will be assessed by the number of treatment sessions and phone calls completed.

  • treatment burden [ Time Frame: 6, 12, and 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Self-reported utilization of health care services (hospitalizations, ER/physician office visits, prescription drugs, etc.) and out-of-pocket costs will be collected.


Estimated Enrollment: 375
Study Start Date: January 2017
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: weight loss intervention
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.
Behavioral: weight loss intervention

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02959021

Contacts
Contact: Janice Phillips 205-975-7914 jmphillips@uabmc.edu
Contact: Renae Glover 205-996-2875 rglover@uabmc.edu

Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Gareth Dutton, PhD University of Alabama at Birmingham
  More Information

Responsible Party: Gareth R. Dutton PhD, Associate Professor of Medicine, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02959021     History of Changes
Other Study ID Numbers: R01DK106041 
Study First Received: November 4, 2016
Last Updated: November 4, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
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.

Keywords provided by University of Alabama at Birmingham:
weight loss
behavioral
primary care
lifestyle

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on December 09, 2016