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

NCT03690557 | Completed

• 1 other identifier: 0581-18-EP
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Delivery of Health Care; Rural Health; Primary Health Care; Outcomes and Process Assessment (Health Care)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Clinically Meaningful Weight Loss

  Baseline, 6, and 12 months

Other Outcomes (3)

• Change in Weight Loss Self-Efficacy Questionnaire Scores

  Baseline and 12 months

• Change in Physical Activity Self-Efficacy Questionnaire Scores

  Baseline and 12 months

• Change in Healthful Eating Self-Efficacy Questionnaire Scores

  Baseline and 12 months

Study Arms (1)

IncentaHealth

EXPERIMENTAL

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

Interventions

IncentaHealth BEHAVIORAL

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.

IncentaHealth

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• American Heart Association: collaborator

Study Sites (1)

Butler County Clinic

David City, Nebraska, 68632, United States

Location

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MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gwenndolyn C Porter, MS

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 1, 2018
• Study Start: October 24, 2018
• Primary Completion: May 21, 2020
• Study Completion: December 31, 2020
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)