- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04461184
The Great Plains Internet Wellness Study for Aging
May 21, 2021 updated by: Ryan McGrath, North Dakota State University
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
14
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
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North Dakota
-
Fargo, North Dakota, United States, 58102
- North Dakota State University Health, Nutrition, and Exercise Sciences
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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
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Internet wellness intervention for aging
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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10-weeks
|
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.
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10-weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
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- Ghanvatkar S, Kankanhalli A, Rajan V. User Models for Personalized Physical Activity Interventions: Scoping Review. JMIR Mhealth Uhealth. 2019 Jan 16;7(1):e11098. doi: 10.2196/11098.
- Gardner B, Lally P, Wardle J. Making health habitual: the psychology of 'habit-formation' and general practice. Br J Gen Pract. 2012 Dec;62(605):664-6. doi: 10.3399/bjgp12X659466. No abstract available.
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- Salimi Y, Shahandeh K, Malekafzali H, Loori N, Kheiltash A, Jamshidi E, Frouzan AS, Majdzadeh R. Is Community-based Participatory Research (CBPR) Useful? A Systematic Review on Papers in a Decade. Int J Prev Med. 2012 Jun;3(6):386-93.
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Helpful Links
- Projections of the Size and Composition of the US Population: 2014 to 2060
- Obesity in Elderly
- Obesity in older adults
- Web-based physical activity interventions for older adults: A review.
- Statistical power analysis for the behavioral sciences.
- Self-determination theory: A macrotheory of human motivation, development, and health.
- United States Department of Health and Human Services
- United States Department of Health and Human Services. Centers for Diseasee Control and Prevention. Introduction to program evaluation for public health programs: a self-study guide
- l. Assessing sleep using hip and wrist actigraphy
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)
January 1, 2021
Primary Completion (Actual)
May 21, 2021
Study Completion (Actual)
May 21, 2021
Study Registration Dates
First Submitted
June 25, 2020
First Submitted That Met QC Criteria
July 1, 2020
First Posted (Actual)
July 8, 2020
Study Record Updates
Last Update Posted (Actual)
May 25, 2021
Last Update Submitted That Met QC Criteria
May 21, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- NorthDakotaSU
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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