Older AdultsNCT04037033
Habit Formation in Older Adults: Feasibility Study
A study testing Everyday Meaningful Activities (EMA) intervention in people with Older Adults, run by East Carolina University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults
- What is being tested?
- Everyday Meaningful Activities (EMA) intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 6 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- upper or lower extremity fracture in the previous 3 months
- current symptomatic hernia
- current symptomatic hemorrhoids
- cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University
Greenville, North Carolina, 57834
About this study
Official title: Forming New Habits: A Feasibility Study on an Intervention to Decrease Sedentary Behaviors in Medically Stable Older Adults
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.
Read more
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.
- Conditions
- Older Adults
- Being tested
- Everyday Meaningful Activities (EMA) intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everyday Meaningful Activities (EMA) interventionBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The recruitment rate for medically stable older adults in the community for this study
Measured: 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
Measured: 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
Measured: 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
Measured: For 6 weeks
Reliability of participants' subjective reports
The reliability of participants' subjective reports of exact times for performing active lifestyle behaviors
Measured: For 6 weeks
Secondary outcomes (2)
Changes in the Self-Report Habit Index
The Self-Report Habit Index (SRHI) measures features of habits including repetition, automaticity, and expressing identity. This 12-item assessment assesses the strength of habits by differentiating habit strength from behavior frequency. The participants will choose two active lifestyle behaviors to incorporate into their daily lives. The SRHI will generate pretest and posttest data for each behavior. The items in the SRHI began with the stem "Behavior X is something…" and is then followed by 12 statements rated on a scale from 1 (very strongly agree) to 7 (very strongly disagree). A total score ranges from 1 to 84 with lower scores indicating stronger habits.
Measured: 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
The Sedentary Behavior Questionnaire (SBQ) is a self-report questionnaire about time spent in sedentary behaviors both on weekdays and weekends. There are 9 identical items on the weekday form and the weekend form. Participants will complete both forms at both time points. The SBQ is used to assess the participants' perceived sedentary time. A total score ranges from 0 to 54 for each (weekday and weekend), with higher scores indicating more sedentary behaviors.
Measured: 1) intervention session 1 at Week 1, and 2) posttest at Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start1 Aug 2019
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, pre-post design
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Joo Kim, East Carolina University
- Investigators
- Young Joo Kim, PhD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037033
- Sponsor's protocol ID
- UMCIRB 19-001365
- Status last verified
- Feb 2021
- First submitted
- 24 Jul 2019
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forming New Habits: A Feasibility Study on an Intervention to Decrease Sedentary Behaviors in Medically Stable Older Adults
- ClinicalTrials.gov ID
- NCT04037033
- Acronym / sponsor ID
- UMCIRB 19-001365
- Conditions
- Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Single group, pre-post design
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- acute or terminal illness
- myocardial infarction in the previous 6 months
- unstable cardiovascular disease
- unstable metabolic disease
- neuromusculoskeletal disorders that severely impact voluntary movement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Everyday Meaningful Activities (EMA) interventionThe 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. | Behavioural | – |
Primary outcome
Recruitment rate
Time frame: Through study completion, an average of 1 year
The recruitment rate for medically stable older adults in the community for this study
Appropriateness of the Rapid Assessment Disuse Index (RADI)
Time frame: During screening
The appropriateness of the Rapid Assessment Disuse Index (RADI) for screening sedentary behavior in older adults over the phone
Appropriateness of the Short Blessed Test
Time frame: During screening
the appropriateness of the Short Blessed Test for screening sufficient cognitive ability in older adults over the phone
Appropriateness of video conferencing through WebEx on an iPad
Time frame: For 6 weeks
The appropriateness of video conferencing through WebEx on an iPad as an acceptable delivery method of selected intervention sessions
Reliability of participants' subjective reports
Time frame: For 6 weeks
The reliability of participants' subjective reports of exact times for performing active lifestyle behaviors
2 secondary outcomes
Changes in the Self-Report Habit Index
Time frame: 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
Time frame: 1) intervention session 1 at Week 1, and 2) posttest at Week 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Joo Kim, PhD principal investigator
East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Everyday Meaningful Activities (EMA) intervention in people with Older Adults, run by East Carolina University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.