ObesityNCT03690557
Examining Reach and Implementation of an Evidence-based Weight Loss Program in Rural Primary Care
A study testing IncentaHealth in people with Obesity, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- IncentaHealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- IncentaHealth
- Keywords
- Delivery of Health Care, Rural Health, Primary Health Care, Outcomes and Process Assessment (Health Care)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncentaHealthBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: IncentaHealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Initial Body Weight Lost/Gained [Effectiveness]
Change in weight, measured in percent of body weight
Measured: Baseline, 6, and 12 months
Enrollment Rate per Each Recruitment Strategy [Reach]
Proportion of individuals who enroll in the program per each recruitment strategy
Measured: In two-week intervals until recruitment cap is met
Secondary outcomes (1)
Clinically Meaningful Weight Loss
Yes/no did the participant lose 5% of their initial body weight
Measured: Baseline, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start24 Oct 2018
- Primary completion21 May 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Gwenndolyn C Porter, MS, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690557
- Sponsor's protocol ID
- 0581-18-EP
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2018
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Befort CA, Nazir N, Perri MG. Prevalence of obesity among adults from rural and urban areas of the United States: findings from NHANES (2005-2008). J Rural Health. 2012 Fall;28(4):392-7. doi: 10.1111/j.1748-0361.2012.00411.x. Epub 2012 May 31.
PubMed 23083085Perri MG, Limacher MC, Durning PE, Janicke DM, Lutes LD, Bobroff LB, Dale MS, Daniels MJ, Radcliff TA, Martin AD. Extended-care programs for weight management in rural communities: the treatment of obesity in underserved rural settings (TOURS) randomized trial. Arch Intern Med. 2008 Nov 24;168(21):2347-54. doi: 10.1001/archinte.168.21.2347.
PubMed 19029500Perri MG, Sears SF Jr, Clark JE. Strategies for improving maintenance of weight loss. Toward a continuous care model of obesity management. Diabetes Care. 1993 Jan;16(1):200-9. doi: 10.2337/diacare.16.1.200.
PubMed 8422776Perri MG, McAdoo WG, Spevak PA, Newlin DB. Effect of a multicomponent maintenance program on long-term weight loss. J Consult Clin Psychol. 1984 Jun;52(3):480-1. doi: 10.1037//0022-006x.52.3.480. No abstract available.
PubMed 6747068Glasgow RE, Goldstein MG, Ockene JK, Pronk NP. Translating what we have learned into practice. Principles and hypotheses for interventions addressing multiple behaviors in primary care. Am J Prev Med. 2004 Aug;27(2 Suppl):88-101. doi: 10.1016/j.amepre.2004.04.019.
PubMed 15275677Ely AC, Befort C, Banitt A, Gibson C, Sullivan D. A qualitative assessment of weight control among rural Kansas women. J Nutr Educ Behav. 2009 May-Jun;41(3):207-11. doi: 10.1016/j.jneb.2008.04.355.
PubMed 19411055Ard JD. Unique perspectives on the obesogenic environment. J Gen Intern Med. 2007 Jul;22(7):1058-60. doi: 10.1007/s11606-007-0243-z. No abstract available.
PubMed 17520309Swinburn B, Egger G. The runaway weight gain train: too many accelerators, not enough brakes. BMJ. 2004 Sep 25;329(7468):736-9. doi: 10.1136/bmj.329.7468.736.
PubMed 15388619Rural 2010 Health Goals and Objectives for Nebraska: Progress Report.; 2008. http://dhhs.ne.gov/Documents/Rural_Prog_Rpt.pdf. Accessed July 21, 2016.
Guh DP, Zhang W, Bansback N, Amarsi Z, Birmingham CL, Anis AH. The incidence of co-morbidities related to obesity and overweight: a systematic review and meta-analysis. BMC Public Health. 2009 Mar 25;9:88. doi: 10.1186/1471-2458-9-88.
PubMed 19320986Olshansky SJ, Passaro DJ, Hershow RC, Layden J, Carnes BA, Brody J, Hayflick L, Butler RN, Allison DB, Ludwig DS. A potential decline in life expectancy in the United States in the 21st century. N Engl J Med. 2005 Mar 17;352(11):1138-45. doi: 10.1056/NEJMsr043743.
PubMed 15784668Donnelly JE, Hill JO, Jacobsen DJ, Potteiger J, Sullivan DK, Johnson SL, Heelan K, Hise M, Fennessey PV, Sonko B, Sharp T, Jakicic JM, Blair SN, Tran ZV, Mayo M, Gibson C, Washburn RA. Effects of a 16-month randomized controlled exercise trial on body weight and composition in young, overweight men and women: the Midwest Exercise Trial. Arch Intern Med. 2003 Jun 9;163(11):1343-50. doi: 10.1001/archinte.163.11.1343.
PubMed 12796071Rejeski WJ, Brubaker PH, Goff DC Jr, Bearon LB, McClelland JW, Perri MG, Ambrosius WT. Translating weight loss and physical activity programs into the community to preserve mobility in older, obese adults in poor cardiovascular health. Arch Intern Med. 2011 May 23;171(10):880-6. doi: 10.1001/archinternmed.2010.522. Epub 2011 Jan 24.
PubMed 21263080Almeida FA, You W, Harden SM, Blackman KC, Davy BM, Glasgow RE, Hill JL, Linnan LA, Wall SS, Yenerall J, Zoellner JM, Estabrooks PA. Effectiveness of a worksite-based weight loss randomized controlled trial: the worksite study. Obesity (Silver Spring). 2015 Apr;23(4):737-45. doi: 10.1002/oby.20899. Epub 2015 Feb 12.
PubMed 25678325Estabrooks PA, Glasgow RE. Translating effective clinic-based physical activity interventions into practice. Am J Prev Med. 2006 Oct;31(4 Suppl):S45-56. doi: 10.1016/j.amepre.2006.06.019.
PubMed 16979469
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Reach and Implementation of an Evidence-based Weight Loss Program in Rural Primary Care
- ClinicalTrials.gov ID
- NCT03690557
- Acronym / sponsor ID
- 0581-18-EP
- Conditions
- Obesity
- Keywords
- Delivery of Health Care, Rural Health, Primary Health Care, Outcomes and Process Assessment (Health Care)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 21 May 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IncentaHealth | Experimental | Behavioral: IncentaHealthAll 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IncentaHealthIncentaHealth 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. | Behavioural | IncentaHealth |
Primary outcome
Percent of Initial Body Weight Lost/Gained [Effectiveness]
Time frame: Baseline, 6, and 12 months
Change in weight, measured in percent of body weight
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
1 secondary outcome
Clinically Meaningful Weight Loss
Time frame: Baseline, 6, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 23083085Befort CA, Nazir N, Perri MG. Prevalence of obesity among adults from rural and urban areas of the United States: findings from NHANES (2005-2008). J Rural Health. 2012 Fall;28(4):392-7. doi: 10.1111/j.1748-0361.2012.00411.x. Epub 2012 May 31.
- Background: PubMed 19029500Perri MG, Limacher MC, Durning PE, Janicke DM, Lutes LD, Bobroff LB, Dale MS, Daniels MJ, Radcliff TA, Martin AD. Extended-care programs for weight management in rural communities: the treatment of obesity in underserved rural settings (TOURS) randomized trial. Arch Intern Med. 2008 Nov 24;168(21):2347-54. doi: 10.1001/archinte.168.21.2347.
- Background: PubMed 8422776Perri MG, Sears SF Jr, Clark JE. Strategies for improving maintenance of weight loss. Toward a continuous care model of obesity management. Diabetes Care. 1993 Jan;16(1):200-9. doi: 10.2337/diacare.16.1.200.
- Background: PubMed 6747068Perri MG, McAdoo WG, Spevak PA, Newlin DB. Effect of a multicomponent maintenance program on long-term weight loss. J Consult Clin Psychol. 1984 Jun;52(3):480-1. doi: 10.1037//0022-006x.52.3.480. No abstract available.
- Background: PubMed 15275677Glasgow RE, Goldstein MG, Ockene JK, Pronk NP. Translating what we have learned into practice. Principles and hypotheses for interventions addressing multiple behaviors in primary care. Am J Prev Med. 2004 Aug;27(2 Suppl):88-101. doi: 10.1016/j.amepre.2004.04.019.
- Background: PubMed 19411055Ely AC, Befort C, Banitt A, Gibson C, Sullivan D. A qualitative assessment of weight control among rural Kansas women. J Nutr Educ Behav. 2009 May-Jun;41(3):207-11. doi: 10.1016/j.jneb.2008.04.355.
- Background: PubMed 17520309Ard JD. Unique perspectives on the obesogenic environment. J Gen Intern Med. 2007 Jul;22(7):1058-60. doi: 10.1007/s11606-007-0243-z. No abstract available.
- Background: PubMed 15388619Swinburn B, Egger G. The runaway weight gain train: too many accelerators, not enough brakes. BMJ. 2004 Sep 25;329(7468):736-9. doi: 10.1136/bmj.329.7468.736.
- BackgroundRural 2010 Health Goals and Objectives for Nebraska: Progress Report.; 2008. http://dhhs.ne.gov/Documents/Rural_Prog_Rpt.pdf. Accessed July 21, 2016.
- Background: PubMed 19320986Guh DP, Zhang W, Bansback N, Amarsi Z, Birmingham CL, Anis AH. The incidence of co-morbidities related to obesity and overweight: a systematic review and meta-analysis. BMC Public Health. 2009 Mar 25;9:88. doi: 10.1186/1471-2458-9-88.
- Background: PubMed 15784668Olshansky SJ, Passaro DJ, Hershow RC, Layden J, Carnes BA, Brody J, Hayflick L, Butler RN, Allison DB, Ludwig DS. A potential decline in life expectancy in the United States in the 21st century. N Engl J Med. 2005 Mar 17;352(11):1138-45. doi: 10.1056/NEJMsr043743.
- Background: PubMed 12796071Donnelly JE, Hill JO, Jacobsen DJ, Potteiger J, Sullivan DK, Johnson SL, Heelan K, Hise M, Fennessey PV, Sonko B, Sharp T, Jakicic JM, Blair SN, Tran ZV, Mayo M, Gibson C, Washburn RA. Effects of a 16-month randomized controlled exercise trial on body weight and composition in young, overweight men and women: the Midwest Exercise Trial. Arch Intern Med. 2003 Jun 9;163(11):1343-50. doi: 10.1001/archinte.163.11.1343.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwenndolyn C Porter, MS principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IncentaHealth in people with Obesity, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Initial Body Weight Lost/Gained [Effectiveness] (time frame: Baseline, 6, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03690557, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.