Internet Based Wellness ProgramNCT04461184
The Great Plains Internet Wellness Study for Aging
A study testing Internet Wellness Intervention for Aging in people with Internet Based Wellness Program and Obesity, run by North Dakota State University at 1 site in United States.
Trial summary
Obesity is a major public health concern in older adults, who are also one of the fastest growing populations in the United States. Engaging in healthy behaviors such as physical activity, a healthy diet, and adequate sleep have each shown to be influential in reducing obesity. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Internet Based Wellness Program, Obesity, Adult Population
- What is being tested?
- Internet Wellness Intervention for Aging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 21 May 2021
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Adults aged at least 65 years that can use the internet daily, have a body mass index of ≥ 30 kg/m2, and are apparently healthy (i.e., medically able to participate in physical activity as determined by the PAR-Q+) Will be eligible for the study.
Who cannot join
- Those with a surgical implant, who are unable to read or speak the English language fluently, with a severe cognitive impairment, and unable to wear an accelerometer on their waist will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Dakota State University Health, Nutrition, and Exercise Sciences
Fargo, North Dakota, 58102
About this study
Official title: The Great Plains Internet Wellness Study for Aging: The GP I-WAS Project
Obesity is a major public health concern in older adults, who are also one of the fastest growing populations in the United States. Engaging in healthy behaviors such as physical activity, a healthy diet, and adequate sleep have each shown to be influential in reducing obesity. The internet could be an effective tool for administering a wellness intervention for older adults. Our goal is to help older adults achieve healthy lifestyles that promote successful aging.
Read the detailed description
Obesity is a major public health concern in older adults, who are also one of the fastest growing populations in the United States. The health consequences associated with obesity in older adulthood are severe and include increased risk for chronic diseases, poor physical functioning and early mortality. Concurrently engaging in healthy behaviors such as physical activity, a healthy diet, and adequate sleep have each shown to be influential in reducing obesity. Despite evidence suggesting that these healthy behaviors reduce the risk for obesity, older adults have difficulty achieving such healthy lifestyles due to barriers such as geographical isolation from lack of transportation, motivation and education. The internet is an effective mode for relaying health information to a wide-ranging audience, including those that live in rural communities or are home bound. Further, internet usage among older adults continues to increase. Therefore, the internet could be an effective tool for administering a wellness intervention for older adults and incorporating community-based participatory research principles such as inviting stakeholders (i.e., older adults) in all phases of the research will magnify the impact of the research for the population in which it is intended to help. Our long-term goal is to help older adults achieve healthy lifestyles that promote successful aging. The overall objective of the proposed research, which is the next step in pursuit of that goal, is to improve healthy lifestyles in older adults by utilizing the internet for delivering a wellness intervention that is designed by both investigators and stakeholders. To propel toward accomplishing our overall objective, the following three specific aims will be pursued: 1) collaborate with stakeholders in all phases of the internet-based wellness intervention to gain knowledge on the perspectives of the older adult population, 2) assess the feasibility of an internet-based wellness intervention for obese older adults, and 3) determine if completing an internet based wellness intervention improves healthy behaviors among obese older adults. We will recruit 20 eligible older adults to participate in an internet-based wellness intervention. A prospective, within-participant design with multiple assessments across the 10-week study period and 1-month follow-up will allow us to optimize power with a smaller sample size and assess within-person change over time.
- Conditions
- Internet Based Wellness Program, Obesity, Adult Population
- Being tested
- Internet Wellness Intervention for Aging
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet Wellness Intervention for AgingBehavioural
Internet technologies have emerged as a platform for performing wellness interventions that also have wide outreach. Previous studies that have used the internet for delivering health interventions have found that older adults valued this platform, used it for researching health information and social communications. Likewise, the effectiveness of delivering health-related information intended for behavior change through the internet is equal to that of print-based delivery, thereby lowering costs and expanding reach. Thus, the internet provides a unique platform for conducting interventions. The internet based wellness intervention will be a low cost method focused on older adults to help increase intrinsic motivation through autonomy, competence, and relatedness (Intrinsic Motivation) to help increase daily physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Internet wellness intervention for aging | Experimental | Feasibility components will be evaluated with a 5-point Likert scale may include open ended items for more detailed feedback. Participants will be asked to visit NDSU at the beginning and end of the intervention, and at 1-month follow-up. After written informed consent, each participant will complete a descriptive questionnaire at the beginning of the intervention period, and a health-related questionnaire at the beginning and end of the intervention, and at follow-up that includes self-rated health, current smoking status, smoking history, alcohol use, morbid conditions, functional disability, and depression status. Standing height and waist circumference will be collected with a tape measure. Body weight and composition will be measured with the InBody 570. Anthropometric and body composition assessments will be collected pre, post, and follow up. Receives: Behavioral: Internet Wellness Intervention for Aging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase Physical Activity and Participation
Actigraph accelerometer and physical activity recall will be used to measure and record physical activity throughout the 10-week internet wellness intervention.
Measured: 10-weeks
Create a more balanced dietary intake based on nutrient dense foods
Participants will complete the Arizona Food Frequency Questionnaire (AFFQ) to assess dietary intake at the beginning and end of the intervention, and at 1-month follow-up. The AFFQ is a modified version of the Health Habits Questionnaire and has demonstrated strong reliability and validity for assessing dietary intake. In addition, each report will contain a personalized message from the dietitian to each participant. Intake of nutritionally dense foods (e.g., vegetables, lean proteins) and decreased intake of calorically dense foods (e.g., high sugar foods) will be compared to assess dietary change.
Measured: 10-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Jan 2021
- Primary completion21 May 2021
- Study completion21 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (55)Papers the sponsor has linked to this study.
- Other trials for Internet Based Wellness ProgramStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Dakota State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan McGrath, North Dakota State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461184
- Sponsor's protocol ID
- NorthDakotaSU
- Status last verified
- May 2021
- First submitted
- 25 Jun 2020
- Last updated
- 25 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hill JO, Catenacci V, Wyatt HR. Obesity: overview of an epidemic. Psychiatr Clin North Am. 2005 Mar;28(1):1-23, vii. doi: 10.1016/j.psc.2004.09.010. No abstract available.
PubMed 15733608Fakhouri TH, Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity among older adults in the United States, 2007-2010. NCHS Data Brief. 2012 Sep;(106):1-8.
PubMed 23102091Zamboni M, Mazzali G, Fantin F, Rossi A, Di Francesco V. Sarcopenic obesity: a new category of obesity in the elderly. Nutr Metab Cardiovasc Dis. 2008 Jun;18(5):388-95. doi: 10.1016/j.numecd.2007.10.002. Epub 2008 Apr 18.
PubMed 18395429Saint Onge JM, Krueger PM. Health Lifestyle Behaviors among U.S. Adults. SSM Popul Health. 2017 Dec;3:89-98. doi: 10.1016/j.ssmph.2016.12.009.
PubMed 28785602Hargens TA, Kaleth AS, Edwards ES, Butner KL. Association between sleep disorders, obesity, and exercise: a review. Nat Sci Sleep. 2013 Mar 1;5:27-35. doi: 10.2147/NSS.S34838. Print 2013.
PubMed 23620691Bales CW, Porter Starr KN. Obesity Interventions for Older Adults: Diet as a Determinant of Physical Function. Adv Nutr. 2018 Mar 1;9(2):151-159. doi: 10.1093/advances/nmx016.
PubMed 29659687Batsis JA, Zagaria AB. Addressing Obesity in Aging Patients. Med Clin North Am. 2018 Jan;102(1):65-85. doi: 10.1016/j.mcna.2017.08.007. Epub 2017 Oct 21.
PubMed 29156188Cohen SA, Greaney ML, Sabik NJ. Assessment of dietary patterns, physical activity and obesity from a national survey: Rural-urban health disparities in older adults. PLoS One. 2018 Dec 5;13(12):e0208268. doi: 10.1371/journal.pone.0208268. eCollection 2018.
PubMed 30517166Douthit N, Kiv S, Dwolatzky T, Biswas S. Exposing some important barriers to health care access in the rural USA. Public Health. 2015 Jun;129(6):611-20. doi: 10.1016/j.puhe.2015.04.001. Epub 2015 May 27.
PubMed 26025176Befort 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 23083085Bolin JN, Bellamy GR, Ferdinand AO, Vuong AM, Kash BA, Schulze A, Helduser JW. Rural Healthy People 2020: New Decade, Same Challenges. J Rural Health. 2015 Summer;31(3):326-33. doi: 10.1111/jrh.12116. Epub 2015 May 7.
PubMed 25953431Jones RB, Ashurst EJ, Atkey J, Duffy B. Older people going online: its value and before-after evaluation of volunteer support. J Med Internet Res. 2015 May 18;17(5):e122. doi: 10.2196/jmir.3943.
PubMed 25986724Marcus BH, Lewis BA, Williams DM, Dunsiger S, Jakicic JM, Whiteley JA, Albrecht AE, Napolitano MA, Bock BC, Tate DF, Sciamanna CN, Parisi AF. A comparison of Internet and print-based physical activity interventions. Arch Intern Med. 2007 May 14;167(9):944-9. doi: 10.1001/archinte.167.9.944.
PubMed 17502536Jonkman NH, van Schooten KS, Maier AB, Pijnappels M. eHealth interventions to promote objectively measured physical activity in community-dwelling older people. Maturitas. 2018 Jul;113:32-39. doi: 10.1016/j.maturitas.2018.04.010. Epub 2018 Apr 25.
PubMed 29903646Rogers MA, Lemmen K, Kramer R, Mann J, Chopra V. Internet-Delivered Health Interventions That Work: Systematic Review of Meta-Analyses and Evaluation of Website Availability. J Med Internet Res. 2017 Mar 24;19(3):e90. doi: 10.2196/jmir.7111.
PubMed 28341617
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Great Plains Internet Wellness Study for Aging: The GP I-WAS Project
- ClinicalTrials.gov ID
- NCT04461184
- Acronym / sponsor ID
- NorthDakotaSU
- Conditions
- Internet Based Wellness Program, Obesity, Adult Population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- North Dakota State UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 8 Jul 2020 (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.
Obesity is a major public health concern in older adults, who are also one of the fastest growing populations in the United States. Engaging in healthy behaviors such as physical activity, a healthy diet, and adequate sleep have each shown to be influential in reducing obesity. The internet could be an effective tool for administering a wellness intervention for older adults. Our goal is to help older adults achieve healthy lifestyles that promote successful aging.
Detailed description
Obesity is a major public health concern in older adults, who are also one of the fastest growing populations in the United States. The health consequences associated with obesity in older adulthood are severe and include increased risk for chronic diseases, poor physical functioning and early mortality. Concurrently engaging in healthy behaviors such as physical activity, a healthy diet, and adequate sleep have each shown to be influential in reducing obesity. Despite evidence suggesting that these healthy behaviors reduce the risk for obesity, older adults have difficulty achieving such healthy lifestyles due to barriers such as geographical isolation from lack of transportation, motivation and education. The internet is an effective mode for relaying health information to a wide-ranging audience, including those that live in rural communities or are home bound. Further, internet usage among older adults continues to increase. Therefore, the internet could be an effective tool for administering a wellness intervention for older adults and incorporating community-based participatory research principles such as inviting stakeholders (i.e., older adults) in all phases of the research will magnify the impact of the research for the population in which it is intended to help. Our long-term goal is to help older adults achieve healthy lifestyles that promote successful aging. The overall objective of the proposed research, which is the next step in pursuit of that goal, is to improve healthy lifestyles in older adults by utilizing the internet for delivering a wellness intervention that is designed by both investigators and stakeholders. To propel toward accomplishing our overall objective, the following three specific aims will be pursued: 1) collaborate with stakeholders in all phases of the internet-based wellness intervention to gain knowledge on the perspectives of the older adult population, 2) assess the feasibility of an internet-based wellness intervention for obese older adults, and 3) determine if completing an internet based wellness intervention improves healthy behaviors among obese older adults. We will recruit 20 eligible older adults to participate in an internet-based wellness intervention. A prospective, within-participant design with multiple assessments across the 10-week study period and 1-month follow-up will allow us to optimize power with a smaller sample size and assess within-person change over time.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internet wellness intervention for aging | Experimental | Behavioral: Internet Wellness Intervention for AgingFeasibility components will be evaluated with a 5-point Likert scale may include open ended items for more detailed feedback. Participants will be asked to visit NDSU at the beginning and end of the intervention, and at 1-month follow-up. After written informed consent, each participant will complete a descriptive questionnaire at the beginning of the intervention period, and a health-related questionnaire at the beginning and end of the intervention, and at follow-up that includes self-rated health, current smoking status, smoking history, alcohol use, morbid conditions, functional disability, and depression status. Standing height and waist circumference will be collected with a tape measure. Body weight and composition will be measured with the InBody 570. Anthropometric and body composition assessments will be collected pre, post, and follow up. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Adults aged at least 65 years that can use the internet daily, have a body mass index of ≥ 30 kg/m2, and are apparently healthy (i.e., medically able to participate in physical activity as determined by the PAR-Q+) Will be eligible for the study.
Key exclusion criteria (1 listed)
- Those with a surgical implant, who are unable to read or speak the English language fluently, with a severe cognitive impairment, and unable to wear an accelerometer on their waist will be excluded.
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 |
|---|---|---|
| Internet Wellness Intervention for AgingInternet technologies have emerged as a platform for performing wellness interventions that also have wide outreach. Previous studies that have used the internet for delivering health interventions have found that older adults valued this platform, used it for researching health information and social communications. Likewise, the effectiveness of delivering health-related information intended for behavior change through the internet is equal to that of print-based delivery, thereby lowering costs and expanding reach. Thus, the internet provides a unique platform for conducting interventions. The internet based wellness intervention will be a low cost method focused on older adults to help increase intrinsic motivation through autonomy, competence, and relatedness (Intrinsic Motivation) to help increase daily physical activity. | Behavioural | Internet wellness intervention for aging |
Primary outcome
Increase Physical Activity and Participation
Time frame: 10-weeks
Actigraph accelerometer and physical activity recall will be used to measure and record physical activity throughout the 10-week internet wellness intervention.
Create a more balanced dietary intake based on nutrient dense foods
Time frame: 10-weeks
Participants will complete the Arizona Food Frequency Questionnaire (AFFQ) to assess dietary intake at the beginning and end of the intervention, and at 1-month follow-up. The AFFQ is a modified version of the Health Habits Questionnaire and has demonstrated strong reliability and validity for assessing dietary intake. In addition, each report will contain a personalized message from the dietitian to each participant. Intake of nutritionally dense foods (e.g., vegetables, lean proteins) and decreased intake of calorically dense foods (e.g., high sugar foods) will be compared to assess dietary change.
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 25 May 2021.
- Background: PubMed 15733608Hill JO, Catenacci V, Wyatt HR. Obesity: overview of an epidemic. Psychiatr Clin North Am. 2005 Mar;28(1):1-23, vii. doi: 10.1016/j.psc.2004.09.010. No abstract available.
- Background: PubMed 23102091Fakhouri TH, Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity among older adults in the United States, 2007-2010. NCHS Data Brief. 2012 Sep;(106):1-8.
- Background: PubMed 18395429Zamboni M, Mazzali G, Fantin F, Rossi A, Di Francesco V. Sarcopenic obesity: a new category of obesity in the elderly. Nutr Metab Cardiovasc Dis. 2008 Jun;18(5):388-95. doi: 10.1016/j.numecd.2007.10.002. Epub 2008 Apr 18.
- Background: PubMed 28785602Saint Onge JM, Krueger PM. Health Lifestyle Behaviors among U.S. Adults. SSM Popul Health. 2017 Dec;3:89-98. doi: 10.1016/j.ssmph.2016.12.009.
- Background: PubMed 23620691Hargens TA, Kaleth AS, Edwards ES, Butner KL. Association between sleep disorders, obesity, and exercise: a review. Nat Sci Sleep. 2013 Mar 1;5:27-35. doi: 10.2147/NSS.S34838. Print 2013.
- Background: PubMed 29659687Bales CW, Porter Starr KN. Obesity Interventions for Older Adults: Diet as a Determinant of Physical Function. Adv Nutr. 2018 Mar 1;9(2):151-159. doi: 10.1093/advances/nmx016.
- Background: PubMed 29156188Batsis JA, Zagaria AB. Addressing Obesity in Aging Patients. Med Clin North Am. 2018 Jan;102(1):65-85. doi: 10.1016/j.mcna.2017.08.007. Epub 2017 Oct 21.
- Background: PubMed 30517166Cohen SA, Greaney ML, Sabik NJ. Assessment of dietary patterns, physical activity and obesity from a national survey: Rural-urban health disparities in older adults. PLoS One. 2018 Dec 5;13(12):e0208268. doi: 10.1371/journal.pone.0208268. eCollection 2018.
- Background: PubMed 26025176Douthit N, Kiv S, Dwolatzky T, Biswas S. Exposing some important barriers to health care access in the rural USA. Public Health. 2015 Jun;129(6):611-20. doi: 10.1016/j.puhe.2015.04.001. Epub 2015 May 27.
- 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 25953431Bolin JN, Bellamy GR, Ferdinand AO, Vuong AM, Kash BA, Schulze A, Helduser JW. Rural Healthy People 2020: New Decade, Same Challenges. J Rural Health. 2015 Summer;31(3):326-33. doi: 10.1111/jrh.12116. Epub 2015 May 7.
- Background: PubMed 25986724Jones RB, Ashurst EJ, Atkey J, Duffy B. Older people going online: its value and before-after evaluation of volunteer support. J Med Internet Res. 2015 May 18;17(5):e122. doi: 10.2196/jmir.3943.
- Projections of the Size and Composition of the US Population: 2014 to 2060Link provided by the sponsor.
- Obesity in ElderlyLink provided by the sponsor.
- Web-based physical activity interventions for older adults: A review.Link provided by the sponsor.
- Statistical power analysis for the behavioral sciences.Link provided by the sponsor.
- Self-determination theory: A macrotheory of human motivation, development, and health.Link provided by the sponsor.
- United States Department of Health and Human ServicesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet Wellness Intervention for Aging in people with Internet Based Wellness Program and Obesity, run by North Dakota State University 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 1 inclusion and 1 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 25 May 2021. 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?
Increase Physical Activity and Participation (time frame: 10-weeks). 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 NCT04461184, which also lists 55 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 25 May 2021.