NCT04461184

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2021

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

5 months

First QC Date

June 25, 2020

Last Update Submit

May 21, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    10-weeks

Study Arms (1)

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.

Behavioral: Internet Wellness Intervention for Aging

Interventions

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.

Internet wellness intervention for aging

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Dakota State University Health, Nutrition, and Exercise Sciences

Fargo, North Dakota, 58102, United States

Location

Related Publications (55)

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Related Links

MeSH Terms

Conditions

Obesity

Interventions

Aging

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 25, 2020

First Posted

July 8, 2020

Study Start

January 1, 2021

Primary Completion

May 21, 2021

Study Completion

May 21, 2021

Last Updated

May 25, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations