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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • North Dakota State University Health, Nutrition, and Exercise Sciences

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Internet Wellness Intervention for Aging
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
10-weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
North Dakota State University

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

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 21, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 21, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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