Obesity Clinical Trial
Official title:
Examining Reach and Implementation of an Evidence-based Weight Loss Program in Rural Primary Care
Verified date | September 2023 |
Source | University of Nebraska |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 98 |
Est. completion date | December 31, 2020 |
Est. primary completion date | May 21, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Butler County Clinic | David City | Nebraska |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska | American Heart Association |
United States,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Weight Loss Self-Efficacy Questionnaire Scores | 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. | Baseline and 12 months | |
Other | Change in Physical Activity Self-Efficacy Questionnaire Scores | 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. | Baseline and 12 months | |
Other | Change in Healthful Eating Self-Efficacy Questionnaire Scores | 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. | Baseline and 12 months | |
Primary | Percent of Initial Body Weight Lost/Gained [Effectiveness] | Change in weight, measured in percent of body weight | Baseline, 6, and 12 months | |
Primary | 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 | Clinically Meaningful Weight Loss | Yes/no did the participant lose 5% of their initial body weight | Baseline, 6, and 12 months |
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