Clinical trial NCT04037033: Habit Formation in Older Adults: Feasibility Study
Official title: Forming New Habits: A Feasibility Study on an Intervention to Decrease Sedentary Behaviors in Medically Stable Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group, pre-post design
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: Through study completion, an average of 1 year
measure: Appropriateness of the Rapid Assessment Disuse Index (RADI)
timeFrame: During screening
measure: Appropriateness of the Short Blessed Test
timeFrame: During screening
measure: Appropriateness of video conferencing through WebEx on an iPad
timeFrame: For 6 weeks
measure: Reliability of participants' subjective reports
timeFrame: For 6 weeks
Secondary outcomes:
measure: Changes in the Self-Report Habit Index
timeFrame: 1) intervention session 1 at Week 1; 2) intervention session 4 at Week 4, and 3) posttest at Week 7
measure: Changes in Sedentary Behavior Questionnaire
timeFrame: 1) intervention session 1 at Week 1, and 2) posttest at Week 7
Other outcomes:
Locations:
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
Study officials:
affiliation: East Carolina University
name: Young Joo Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References: