Aging Clinical Trial
Official title:
A Personalized Trial Pilot to Test Habit Formation Theory for Low Intensity Physical Exercise in Older Adults
Verified date | November 2022 |
Source | Northwell Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This personalized trial will evaluate the effects of five behavioral change techniques (BCTs) described in Habit Formation Theory (Goal setting, Action Planning, Self-Monitoring, Behavioral Practice/Rehearsal and Habit Formation) delivered by text message to enhance low-intensity walking by 2,000 more steps per day/5 days per week in healthy Northwell employees aged 45-75 years old.
Status | Completed |
Enrollment | 49 |
Est. completion date | May 31, 2022 |
Est. primary completion date | February 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years to 75 Years |
Eligibility | Inclusion Criteria: Men and women who: - Age 45 - 75 years old of age - Fluent in English - Employed in the Northwell Health system - Community-dwelling - Report they are in good general health, walk regularly and have never been informed by a clinician that it was not advisable/safe to participate in a low-intensity walking program - Owns and can regularly access a smartphone capable of receiving text messages - Owns and can regularly access an e-mail account Exclusion Criteria for Factors that May Limit Adherence to Interventions or Affect Conduct of the Trial - < 45 years old or > 75 years old - Unable to speak/comprehend English - Not employed in Northwell Health system - Have self-reported poor health, limited mobility and/or have been advised by a clinician not to increase their low-intensity walking - Pregnancy - Previous diagnosis of a serious mental health condition or psychiatric disorder, such as bipolar disorder |
Country | Name | City | State |
---|---|---|---|
United States | Center for Personalized Health | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health | Columbia University, National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Automaticity Score. | Automaticity of behavior is assessed by a 4-item questionnaire asking about the automaticity of participant's walking behavior using a 4-point Likert scale with responses ranging from "Strongly Disagree" to "Strongly Agree". Items are summed together to form a total score ranging from 0 to 12, with higher scores indicating that participant's new walking behaviors have become more habitual and automatic. Change in daily automaticity levels over the course of the intervention period will be examined until scores level out and reach a score of 8 or more on 7 consecutive days. Participants will be judged to have reached an asymptote at this point in time. The proportion of the sample that has achieved automaticity will be reported as a number with percentage [N(%)]. Time-to-event analyses will be conducting examining participant differences in reaching an asymptote for automaticity and overall time-to-event will represented using Kaplan-Meier curves. | Assessed daily via online survey for participants across the duration of the 10-week intervention. Daily assessments will be aggregated by week to generate weekly means for automaticity. | |
Primary | Participant Satisfaction With Personalized Trial Components. | Participants will rate their satisfaction with the Personalized Trial overall and with individual elements of the trial in a satisfaction survey developed for this trial. Participants will rate 9 items assessing satisfaction with methods and process of the trial on a 4-point Likert scale with responses ranging from "0 - Not at all satisfied" to "3 - Very satisfied". Higher scores indicate greater levels of satisfaction. Means and standard deviations will be reported for each element of satisfaction. | Assessed once after completion of the study at 12 weeks. | |
Secondary | Within-person Change in Daily Steps. | Participant steps will be assessed continuously using a Fitbit mobile device. Daily steps for participants will be aggregated by baseline and intervention phases to generate average daily steps in each phase. Changes in daily steps between baseline and intervention phases will be compared using Generalized Linear Mixed Model analyses. | Steps will be assessed continuously via worn activity tracker and step counts will be reported daily. | |
Secondary | Proportion of Days Adhering to Walking Habit. | This is assessed using a single yes/no item assessed daily asking participants "Did you walk according to your walking plan today?". For each participant, we will identify the proportion of days during the 10-week intervention where the participant adhered to the walking plan. Proportions of adherence will reported across all participants with means and standard deviations. | Assessed once after completion of the study at 12 weeks. | |
Secondary | Participant Attitudes and Opinions Towards Personalized Trials. | Participants will be asked via survey about their attitudes and opinions regarding the personalized trial implementation (e.g., Did the trial feel burdensome?). Participants will rate items on a 7-point Likert scale with responses ranging from "0 - Strongly Disagree" to "6 - Strongly Agree". Higher scores indicate greater levels of agreement. Scores on each item will be reported with means and standard deviations. | Assessed once after the completion of the intervention period. | |
Secondary | Participant Adherence to Self-Monitoring. | This will be measured via a single survey item delivered following a participant's scheduled walking time asking them to record the number of steps they took on their walk. Individuals who complete this item and record their steps will be judged to be adherent to self-monitoring of their walking behavior. Participant adherence will be aggregated over the course of the 10-week intervention and will be reported as proportion of days adherent to self-monitoring. Proportions of adherence will be reported across all participants with means and standard deviations. | Assessed daily via online survey for participants across the duration of the 10 week intervention. Daily responses will be aggregated across the intervention to determine an overall proportion of days adherent self-monitoring of behavior. |
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