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

September 26, 2023 updated by: University of Nebraska
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • David City, Nebraska, United States, 68632
        • Butler County Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Initial Body Weight Lost/Gained [Effectiveness]
Time Frame: Baseline, 6, and 12 months
Change in weight, measured in percent of body weight
Baseline, 6, and 12 months
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
In two-week intervals until recruitment cap is met

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 months
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.
Baseline and 12 months
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.
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

American Heart Association

Investigators

  • Principal Investigator: Gwenndolyn C Porter, MS, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2018

Primary Completion (Actual)

May 21, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

September 25, 2018

First Submitted That Met QC Criteria

September 27, 2018

First Posted (Actual)

October 1, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0581-18-EP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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