Habit Formation in Older Adults: Feasibility Study

Older Adults Clinical Trial

Official title:

Forming New Habits: A Feasibility Study on an Intervention to Decrease Sedentary Behaviors in Medically Stable Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04037033
• Other study ID #: UMCIRB 19-001365
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: March 6, 2020

Study information

• Verified date: February 2021
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 6, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Older Adults

Intervention

Behavioral:
• Everyday Meaningful Activities (EMA) intervention
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.

Locations

Country	Name	City	State
United States	East Carolina University	Greenville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
East Carolina University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	The recruitment rate for medically stable older adults in the community for this study	Through study completion, an average of 1 year
Primary	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
Primary	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
Primary	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
Primary	Reliability of participants' subjective reports	The reliability of participants' subjective reports of exact times for performing active lifestyle behaviors	For 6 weeks
Secondary	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.	1) intervention session 1 at Week 1; 2) intervention session 4 at Week 4, and 3) posttest at Week 7
Secondary	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.	1) intervention session 1 at Week 1, and 2) posttest at Week 7