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Completed

NCT Number: NCT04037033

Habit Formation in Older Adults: Feasibility Study

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.

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Key information

Conditions

Older Adults

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East Carolina University

Greenville, North Carolina, 57834, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Everyday Meaningful Activities (EMA) intervention

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Reliability of participants' subjective reports

    Time frame: For 6 weeks

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

Secondary outcomes

  1. 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

    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.

  2. Changes in Sedentary Behavior Questionnaire

    Time frame: 1) intervention session 1 at Week 1, and 2) posttest at Week 7

    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.

Sponsors and collaborators

Lead sponsor

East Carolina University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 30, 2019
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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