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Trial record 43 of 1366 for:    rural

Examining Reach and Implementation of an Evidence-based Weight Loss Program in Rural Primary Care

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ClinicalTrials.gov Identifier: NCT03690557
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Gwenndolyn Porter, University of Nebraska

Brief Summary:
The majority of American adults do not meet recommended guidelines for healthy eating or physical activity and are overweight or obese, which puts them at risk for chronic disease, poor quality of life, and increased personal and public health care costs. Despite the development and success of a number of evidence-based weight management interventions, these programs have lacked systematic and consistent translation in clinical practice or community services. Further, few of these interventions have been tested in rural populations, where there is a disproportionally high number of obese individuals, and resources to support such programs are lacking. Primary care clinics have the necessary resources to support such programs, and might be the ideal setting to intervene and address concerns of weight loss and management in rural areas. The intent of the proposed project is to increase the capacity of primary care in rural Nebraska to translate evidence-based weight management approaches into practice, improve the speed of uptake and the likelihood of sustainability, and reach a large and representative group of individuals. To achieve this, the investigators will 1) conduct a limited effectiveness and feasibility study to determine impact on weight loss of 100 overweight and obese adult patients in a rural Nebraska primary care clinic, and 2) test multiple strategies for recruitment to determine best practices for program reach. The primary outcome for program effectiveness is percent body weight loss, and the primary outcome for program feasibility is reach, defined as the proportion of individuals who enroll in the program per each recruitment strategy. The proposed project provides a means of implementing an evidence-based weight loss program in rural Nebraska, has the capacity to create meaningful change in patient weight status, and has the potential to influence future efforts to translate evidence-based weight management programs into rural primary care practice.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: IncentaHealth Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Examining Reach and Implementation of an Evidence-based Weight Loss Program in Rural Primary Care
Actual Study Start Date : October 24, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IncentaHealth
All patients who decide to join the weight loss program will be enrolled in the commercially-available IncentaHealth program - a comprehensive, evidence-based, behavioral weight management program designed to help patients initiate and maintain weight loss. The program is delivered completely online, via website, emails, mobile app, and (if requested by the participant) text messaging over 12 months. Each participant will be given a digital scale that wirelessly syncs with a smartphone app. Participants' weights are automatically uploaded to the Incentahealth online portal. In the informed consent process, participants will need to agree to release their weight data to researchers at the University of Nebraska Medical Center in order to participate in this program.
Behavioral: IncentaHealth
IncentaHealth is a comprehensive, behavioral weight management program designed to help individuals initiate and maintain weight loss. Individuals participate in the IncentaHealth program from their homes, receive program information electronically through daily emails and through a smartphone app for the duration of the study, and have the option to receive text messages and speak with health coaches over the telephone. Participants in this study will be enrolled in the IncentaHealth program for 12 months, and will engage with health coaching, tracking of body weight, and are provided a number of resources for healthy living throughout the 12 months.




Primary Outcome Measures :
  1. Percent of Initial Body Weight Lost/Gained [Effectiveness] [ Time Frame: Baseline, 6, and 12 months ]
    Change in weight, measured in percent of body weight

  2. Enrollment Rate per Each Recruitment Strategy [Reach] [ Time Frame: In two-week intervals until recruitment cap is met ]
    Proportion of individuals who enroll in the program per each recruitment strategy


Secondary Outcome Measures :
  1. Clinically Meaningful Weight Loss [ Time Frame: Baseline, 6, and 12 months ]
    Yes/no did the participant lose 5% of their initial body weight


Other Outcome Measures:
  1. Change in Weight Loss Self-Efficacy Questionnaire Scores [ Time Frame: Baseline and 12 months ]
    Changes in scores of self-efficacy for weight loss using the Weight Loss Self-Efficacy subscale as described in Wilson et al, 2016. Scores range from 0 (least confident) to 100 (most confident). An increase in score from baseline to 12 months indicates an increase in self-efficacy for weight loss.

  2. Change in Physical Activity Self-Efficacy Questionnaire Scores [ Time Frame: Baseline and 12 months ]
    Changes in scores of self-efficacy for physical activity using the Physical Activity Self-Efficacy subscale as described in Wilson et al, 2016. Scores range from 0 (least confident) to 100 (most confident). An increase in score from baseline to 12 months indicates an increase in self-efficacy for physical activity.

  3. Change in Healthful Eating Self-Efficacy Questionnaire Scores [ Time Frame: Baseline and 12 months ]
    Changes in scores of self-efficacy for healthful eating using the Healthful Eating Self-Efficacy subscale as described in Wilson et al, 2016. Scores range from 0 (least confident) to 100 (most confident). An increase in score from baseline to 12 months indicates an increase in self-efficacy for healthful eating.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient of Butler County Clinic in David City, Nebraska
  2. BMI ≥25 (determined by patients electronic medical record measurement)
  3. Aged 19 or older
  4. Own an Apple or Android smartphone
  5. Have an active email address and have an understanding of how to navigate the internet
  6. Able to engage in physical activity and modify eating habits
  7. Approved to participate by primary care provider
  8. Capable of providing consent to participate

Exclusion Criteria:

  1. Not meeting all inclusion criteria
  2. Currently scheduled for bariatric surgery or had bariatric surgery within the past 3 years
  3. Currently undergoing treatment for cancer
  4. Currently on a prescribed medical diet
  5. Diagnosed with an eating disorder
  6. Currently participating in another weight management activity or interventional research trial
  7. Had a heart attack or stroke within the past 6 months or currently in cardiac rehabilitation
  8. Currently on dialysis or an active organ transplant list
  9. Currently pregnant or planning to become pregnant in the next 12 months
  10. Planning to move outside of the recruitment area in the next 12 months

Information from the National Library of Medicine

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): NCT03690557


Contacts
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Contact: Gwenndolyn Porter, MS 4025591082 gwenndolyn.porter@unmc.edu

Locations
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United States, Nebraska
Butler County Clinic Recruiting
David City, Nebraska, United States, 68632
Contact: Gwenn Porter    402-559-1082      
Sponsors and Collaborators
University of Nebraska
American Heart Association
Investigators
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Principal Investigator: Gwenndolyn Porter, MS University of Nebraska

Publications:
Rural 2010 Health Goals and Objectives for Nebraska: Progress Report.; 2008. http://dhhs.ne.gov/Documents/Rural_Prog_Rpt.pdf. Accessed July 21, 2016.
Huang TT-K, Grimm B, Hammond RA. A systems-based typological framework for understanding the sustainability, scalability, and reach of childhood obesity interventions. Child Heal Care. 2011;40(3):253-266. doi:10.1080/02739615.2011.590399
Cancer Prevention and Control Research Network. Putting Public Health Evidence in Action. Produced by the Centers for Disease Control and Prevention and the National Cancer Institute. Retreived from http://cpcrn.org/pub/evidence-in-action/, October 2017.

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Responsible Party: Gwenndolyn Porter, Graduate Research Assistant, University of Nebraska
ClinicalTrials.gov Identifier: NCT03690557     History of Changes
Other Study ID Numbers: 581-18-EP
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gwenndolyn Porter, University of Nebraska:
Delivery of Health Care
Rural Health
Primary Health Care
Outcomes and Process Assessment (Health Care)
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms