Partnership Optimizes Weight Management in Primary Care (PROMISE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02959021|
Recruitment Status : Active, not recruiting
First Posted : November 8, 2016
Last Update Posted : July 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: weight loss intervention - self directed Behavioral: weight loss intervention - peer coach||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||375 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Primary Care Obesity Management in the Southeast_PROMISE|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||March 2021|
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 - 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.
Behavioral: weight loss intervention - peer coach
- body weight [ Time Frame: 6, 12, and 18 months ]change in body weight (kg) from baseline to follow-up assessments
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959021
|United States, Alabama|
|University of Alabama in Birmingham|
|Birmingham, Alabama, United States, 35233|
|Principal Investigator:||Gareth Dutton, PhD||University of Alabama at Birmingham|