NCT04037033

Brief Summary

Sedentary behavior, which is characterized by too much sitting, is an epidemic in the United States. It is estimated that 4 out of every 10 Americans never engage in physical activity, and approximately 60% of an adult's non-sleeping hours are spent in sedentary behaviors. This equates to approximately 9-10 hours per day. As sedentary behavior increases, so do diagnoses of chronic illnesses such as diabetes, hypertension, cardiovascular disease, and kidney disease. Older adults are particularly at risk for sedentary behavior and the related chronic illnesses. The primary aim of this study is to investigate the feasibility of implementing the EMA intervention with medically stable older adults who are living in the community. The secondary aims of this study are to investigate the effectiveness of the Everyday Meaningful Activities (EMA) Intervention in forming active lifestyle behavior habits and in decreasing an individual's perceived sedentary time. This prospective study will examine the ability of medically stable older adults to decrease sedentary behavior by creating new, active lifestyle behavior habits using the Everyday Meaningful Activities intervention. The EMA Intervention is based in Habit Formation Theory. It is an individualized, client-centered intervention that aims to increase adherence to active lifestyle behaviors in older adults' lives. Participants will engage in the EMA Intervention that is designed to create new active lifestyle behavior habits by attaching these new active lifestyle behaviors to currently existing daily routines. During six intervention sessions over six weeks, participants will select two new active lifestyle behaviors to make habitual and will create action plans to create the habits. The first behavior will be implemented at the first intervention session, and the second behavior will be implemented at the fourth session. The participants will be assessed three times over their 8 to 10-week study participation. Participants should (1) be 65 years of age and older, (2) have intact cognition, (3) have no self-reported physical activity limitations, (4) have a sedentary lifestyle, and (5) have no acute illnesses or unstable medical conditions. The results of this study may provide evidence for the occupational therapy intervention to decrease sedentary behavior in older adults in the community. The results may also broaden the scope of occupational therapy practice through demonstrating the potential for occupational therapy services in preventive health care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2020

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

July 24, 2019

Last Update Submit

February 3, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • Recruitment rate

    The recruitment rate for medically stable older adults in the community for this study

    Through study completion, an average of 1 year

  • Appropriateness of the Rapid Assessment Disuse Index (RADI)

    The appropriateness of the Rapid Assessment Disuse Index (RADI) for screening sedentary behavior in older adults over the phone

    During screening

  • Appropriateness of the Short Blessed Test

    the appropriateness of the Short Blessed Test for screening sufficient cognitive ability in older adults over the phone

    During screening

  • Appropriateness of video conferencing through WebEx on an iPad

    The appropriateness of video conferencing through WebEx on an iPad as an acceptable delivery method of selected intervention sessions

    For 6 weeks

  • Reliability of participants' subjective reports

    The reliability of participants' subjective reports of exact times for performing active lifestyle behaviors

    For 6 weeks

Secondary Outcomes (2)

  • Changes in the Self-Report Habit Index

    1) intervention session 1 at Week 1; 2) intervention session 4 at Week 4, and 3) posttest at Week 7

  • Changes in Sedentary Behavior Questionnaire

    1) intervention session 1 at Week 1, and 2) posttest at Week 7

Interventions

The EMA intervention will include 6 intervention sessions. At session 1, the interventionist and participant will identify 2 meaningful active lifestyle behavior goals using COPM. Last, an action plan will be created for behavior 1. Participants will be asked to implement the action plan everyday. At session 2, the interventionist and participants will review the daily activity log and the action plan. At session 3, the interventionist and the participants will review the daily activity log and the action plan. At session 4, an action plan will be created for behavior 2. Participants will be asked to implement the action plan for behavior 2 everyday. At session 5, the participants and interventionists will discuss the participant's daily activity log and action plan. At session 6, the participants and interventionists will discuss the participant's daily activity log and action plan.

Eligibility Criteria

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

You may qualify if:

  • age 65 or older,
  • intact cognition as confirmed by the Montreal Cognitive Assessment blind version
  • no physical activity restrictions that can be self-reported
  • sedentary lifestyle as confirmed by the Rapid Assessment Disuse Index
  • live within 20 miles of the College of Allied Health Sciences at ECU
  • have access to the internet and/or a telephone for remote intervention sessions

You may not qualify if:

  • acute or terminal illness
  • myocardial infarction in the previous 6 months
  • unstable cardiovascular disease
  • unstable metabolic disease
  • neuromusculoskeletal disorders that severely impact voluntary movement
  • limb amputation
  • upper or lower extremity fracture in the previous 3 months
  • current symptomatic hernia
  • current symptomatic hemorrhoids
  • cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Carolina University

Greenville, North Carolina, 57834, United States

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Young Joo Kim, PhD

    East Carolina University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single group, pre-post design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 24, 2019

First Posted

July 30, 2019

Study Start

August 1, 2019

Primary Completion

March 6, 2020

Study Completion

March 6, 2020

Last Updated

February 5, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations