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

Study Overview
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Brief Summary
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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.

Detailed Description
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In the United States, the choice to eat energy-dense foods and engage in sedentary activities is attractive and convenient. More than two thirds of adults in the US are either overweight or obese, with rural residents experiencing a disproportionally higher prevalence of obesity, particularly in the state of Nebraska. Excess body weight carries with it a host of adverse conditions: type II diabetes, coronary heart disease, hypertension, some cancers, and early mortality. The high prevalence of obesity and its consequences have catalyzed the development of many weight management interventions that have been effective in helping individuals initiate weight loss and maintain a healthy weight. Despite their demonstrated efficacy, few of these programs have been systematically and consistently translated into typical clinical practice or community services. This translation is especially scarce in rural communities. Programs designed to improve weight loss that target rural communities can be a challenge to design and implement, due to the lack of resources available in rural communities to support such programs. However, primary care clinics may provide an ideal setting to implement effective diet, physical activity, and weight management support. Despite the lack of resources, most rural communities have a primary care provider who is trusted by patients to provide counseling on healthy behaviors. Furthermore, programs delivered through the private sector that engage patients and organizational decision makers, such as primary care providers, are hypothesized to be more sustainable. Primary care systems may offer a practical and sustainable method of implementing meaningful weight management interventions, but few weight management programs are currently available that can be readily adopted into rural primary care practice. To address the gap in translating programs into practice, the investigators will use the National Cancer Institutes (NCI) Putting Public Health Evidence in Action process, which provides steps for defining evidence-based programs, assessing resources and need in the community, and ultimately choosing an evidence based program for implementation. The investigators will modify the NCI process to include, but move beyond, simply considering the magnitude of weight loss as the primary factor in the selection process. Additionally, the investigators will address factors related to scalability, clinical uptake, and sustainability which are key for the translation of evidence-based interventions into practice. The RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework will be used to consider the impact at the individual and organizational levels of the weight management approaches. Reach (i.e., the participation rate of individuals from the target population and representativeness of those who participate) and effectiveness are the two factors considered to contribute to overall impact when translating evidence-based strategies into typical practice. These factors can be addressed by developing a system within primary care that provides opportunities for quick and representative accrual of participants, provides clinics with an evidence-based program, and provides a tracking and evaluating system to determine the potential population health impact of the intervention. 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.Effective weight loss programs are available, but the question of how best to deliver these interventions to the general public remains. The proposed study will help to improve the translation of evidence-based programs into typical clinical practice and determine best practices for patient recruitment and referral. This will be done through the completion of the following aims: Aim 1: Conduct a limited effectiveness and feasibility (including cost) study of the IncentaHealth intervention to determine impact on weight loss of 100 overweight and obese patients. The proportion of participants who experience a clinically meaningful weight loss (i.e., 5% initial body weight) at 6-months and cost per participant achieving this bench march will also be reported. Aim 2: Test methods to increase intervention reach using a 2X2 randomized recruitment design (in-visit referral vs electronic health record screening and mailed referral; active vs passive follow-up) within a rural primary care clinic in Nebraska. The completion of these aims has the potential to affect the health of rural Nebraskans and influence future efforts to translate evidence-based weight management programs into rural primary-care practice.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: IncentaHealth


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient of Butler County Clinic in David City, Nebraska BMI ≥25 (determined by patients electronic medical record measurement) Aged 19 or older Own an Apple or Android smartphone Have an active email address and have an understanding of how to navigate the internet Able to engage in physical activity and modify eating habits Approved to participate by primary care provider Capable of providing consent to participate Exclusion Criteria: Not meeting all inclusion criteria Currently scheduled for bariatric surgery or had bariatric surgery within the past 3 years Currently undergoing treatment for cancer Currently on a prescribed medical diet Diagnosed with an eating disorder Currently participating in another weight management activity or interventional research trial Had a heart attack or stroke within the past 6 months or currently in cardiac rehabilitation Currently on dialysis or an active organ transplant list Currently pregnant or planning to become pregnant in the next 12 months Planning to move outside of the recruitment area in the next 12 months

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IncentaHealth<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Initial Body Weight Lost/Gained [Effectiveness] | Change in weight, measured in percent of body weight | Baseline, 6, and 12 months | 
| Enrollment Rate per Each Recruitment Strategy [Reach] | Proportion of individuals who enroll in the program per each recruitment strategy | In two-week intervals until recruitment cap is met | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically Meaningful Weight Loss | Yes/no did the participant lose 5% of their initial body weight | Baseline, 6, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Outcomes and Process Assessment (Health Care), Delivery of Health Care, Rural Health, Primary Health Care