- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04461184
The Great Plains Internet Wellness Study for Aging
21. Mai 2021 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
14
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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North Dakota
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Fargo, North Dakota, Vereinigte Staaten, 58102
- North Dakota State University Health, Nutrition, and Exercise Sciences
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
65 Jahre und älter (Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Increase Physical Activity and Participation
Zeitfenster: 10-weeks
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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
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Create a more balanced dietary intake based on nutrient dense foods
Zeitfenster: 10-weeks
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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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
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Nützliche 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
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Januar 2021
Primärer Abschluss (Tatsächlich)
21. Mai 2021
Studienabschluss (Tatsächlich)
21. Mai 2021
Studienanmeldedaten
Zuerst eingereicht
25. Juni 2020
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
1. Juli 2020
Zuerst gepostet (Tatsächlich)
8. Juli 2020
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
25. Mai 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
21. Mai 2021
Zuletzt verifiziert
1. Mai 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- NorthDakotaSU
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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