Health Education and Lifestyle Training in Older Adults

NCT ID: NCT03432754

Last Updated: 2018-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-20

Study Completion Date

2015-04-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators conducted a mindfulness training intervention in older adults aimed at examining the effects of brief mindfulness training on mind wandering as well as the cognitive and affective functioning of older adults. Individuals completed pre- and post-assessments of mind wandering and cognitive functioning. Additionally, all participants completed neuropsychological measures and self-report questionnaires.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Age-related differences in sustained attention may be related to the prevalence and content of task unrelated thought or mind-wandering. Older adults report less mind-wandering in sustained tasks than younger adults, something that is surprising due to the reduced performance on tasks. It is clear that both cognitive and emotional processes underlie comprehension and sustained attention and relate to prevalence of task unrelated thought and performance. A complex process such as reading comprehension presents a challenge for improvement because of the wide range of changes that occur with age. Pharmacological therapies can target only a limited number of the many changes believed to underlie functional decline. One way that may mitigate these declines in performance in a broad way is mindfulness training. Thus, the investigators conducted a randomized study to assess the effects of mindfulness training relative to an active health education control group on mind wandering and controlled processing abilities in older adults. All individuals that contact the Clinical Neuroscience Laboratory (CNLab) with interest underwent a phone screening assessing inclusion/exclusion criteria.Those participants meeting I/E criteria were invited to participate in the study. During the first assessment session, written informed consent was obtained; additional inclusion/exclusion measures were administered; and self-report questionnaires and assessment measures were completed. Following the first assessment session, four training sessions took place. Participants were randomized into either the a mindfulness training intervention or a health education intervention. Subsequently, all participants were invited back for post-assessment session.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Older Adults

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This randomized control trial compared a mindfulness-based attention training (MBAT) group with an active control lifestyle education group. A total of 147 individuals underwent eligibility screening over the phone and in-person at an initial assessment session. Of those eligible, 75 participants volunteered to participate and were randomly assigned to groups. However, one of these participants did not complete the first assessment session and was randomized in error. Thus, 74 participants who completed the first assessment session and met all eligibility criteria were randomly assigned to either the MBAT group or the active control group (lifestyle education). Randomization was conducted by a study author using a computerized random number generator program (randomization.com), applying a varying block size of two and four and stratifying participants by gender. A total of 37 participants were allocated to the each of the two groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Randomization was conducted by the principle investigator (PI) and study coordinator using a computerized random number generator program (randomization.com). All experimenters (except the PI and study coordinator) were blinded to group assignments until study conclusion. To further reduce demand characteristics, participants were unaware of which group was considered the experimental intervention until debriefed by an experimenter after completing the study. Study binders were created to blind group assignment, and participants in each group were asked not to discuss the sessions with members of the other group or with the experimenter at their post-intervention assessment.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mindfulness-Based Attention Training

Four weekly group mindfulness attention training sessions of a 1.5-hour duration. Participants provided with audio recordings, readings, and homework assignments consisting of various mindfulness practices.

Group Type EXPERIMENTAL

Mindfulness-Based Attention Training

Intervention Type BEHAVIORAL

The mindfulness-based attention training is closely modeled after the traditional mindfulness-based stress reduction (MBSR) protocol, it incorporates formal MBSR practices such as breath exercises, body scans and long sitting meditations. Specifically, MBAT is an abbreviated version of MBSR with a focus on the cognitive components.

Lifestyle Education Group

Four weekly group lifestyle education sessions of a 1.5-hour duration. Homework consisting of reading, diet monitoring, stretching/toning exercises, and brainstorming new healthy living techniques/ideas.

Group Type ACTIVE_COMPARATOR

Lifestyle Education

Intervention Type BEHAVIORAL

The control group, which will be used to compare the effects of mindfulness training on emotional and cognitive functioning and mind wandering in older adults, will comprise of scientific health and lifestyle information. Lectures will be focused on concepts presented in the book "The Culprit and the Cure: Why lifestyle is the culprit behind America's poor health and how transforming that lifestyle can be the cure." Meetings will cover how to begin and maintain a more nutritious diet, classifying healthy choices across food groups, completing stretching/toning exercises, and reviewing homework.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mindfulness-Based Attention Training

The mindfulness-based attention training is closely modeled after the traditional mindfulness-based stress reduction (MBSR) protocol, it incorporates formal MBSR practices such as breath exercises, body scans and long sitting meditations. Specifically, MBAT is an abbreviated version of MBSR with a focus on the cognitive components.

Intervention Type BEHAVIORAL

Lifestyle Education

The control group, which will be used to compare the effects of mindfulness training on emotional and cognitive functioning and mind wandering in older adults, will comprise of scientific health and lifestyle information. Lectures will be focused on concepts presented in the book "The Culprit and the Cure: Why lifestyle is the culprit behind America's poor health and how transforming that lifestyle can be the cure." Meetings will cover how to begin and maintain a more nutritious diet, classifying healthy choices across food groups, completing stretching/toning exercises, and reviewing homework.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 60 to 74 years of age
* No prior exposure to mindfulness training
* No significant meditation experience
* Have never engaged in regular practices of yoga
* Capable of attending both assessment and training sessions
* Corrected (near and far) visual acuity of 20/40 or better
* Normal color vision
* No self-reported history of psychiatric, neurological, or chronic inflammatory conditions
* Absence of psychiatric medication use
* Native English Speaker
* Adequate performance on the Mini-Mental Status Examination (MMSE; \>23)
* Depression score on the Geriatric Depression Scale (GDS) below clinical level (\<10)

Exclusion Criteria

* Below 60 years of age or above 74 years of age
* Have exposure to or experience with any type of meditation or yoga regularly (one hour a week for at least 12 months)
* Any physical or pragmatic limitation that prohibits attendance at both sessions
* Corrected (near or far) visual acuity worse than 20/40
* All types of color blindness
* Presence of diagnosed neurological disorders (such as: Alzheimer's disease, Parkinson's disease or multiple sclerosis) or chronic inflammatory conditions
* Presence of any diagnosed psychiatric disorder such as depression, attention deficit hyperactivity disorder (ADHD), substance abuse
* Presence of psychiatric medication use such as Xanax, Wellbutrin, or Vivance
* Non-Native English Speaker or no fluency in English
* Inadequate performance on the Mini-Mental Status Examination (MMSE; \<23)
* Depression score on GDS indicative of clinical depression (\>10)
Minimum Eligible Age

60 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ruchika Prakash

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ruchika Prakash, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

References

Explore related publications, articles, or registry entries linked to this study.

Fountain-Zaragoza S, Londeree A, Whitmoyer P, Prakash RS. Dispositional mindfulness and the wandering mind: Implications for attentional control in older adults. Conscious Cogn. 2016 Aug;44:193-204. doi: 10.1016/j.concog.2016.08.003. Epub 2016 Aug 16.

Reference Type RESULT
PMID: 27541935 (View on PubMed)

Duraney EJ, Phansikar M, Prakash RS. Psychosocial Correlates of Adherence to Mind-Body Interventions. Prev Sci. 2025 Jul;26(5):839-848. doi: 10.1007/s11121-025-01810-1. Epub 2025 May 6.

Reference Type DERIVED
PMID: 40325320 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014B0337

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.