NCT04128553

Brief Summary

Older adults constitute the age group that leads the most sedentary life in society and is mostly affected by physical inactivity. This study was conducted to determine how nurse-led Motivational Interviewing (MI) based on the Trans-Theoretical Model (TTM) affected promoting physical activity in older adults. A randomised controlled trial. The population of this trial was composed of seniors aged between 65 and74 living in a family health center area in Yozgat, Turkey (N=1630). The study sample, estimated via power analysis (d=0.30; 1-β=0.80; α=0.05), constituted 117 older adults (Intervention Group (IG) n=58; Control Group (CG) n=59) who met the inclusion criteria. The data were gathered via a questionnaire, TTM-Scales, Physical Activity Scale for Elderly (PASE), KATZ-ADL by an independent researcher who was blinded to the study groups. A pedometer (JP-600) for each senior was used to calculate the average weekly step counts. The data were analyzed via IBM-SPSS version 23.0. Descriptive statistics, student's t-test, paired-samples t-test, Mann Whitney-U, the Wilcoxon Sign, Friedman, Pearson chi-square, and Fisher-Freeman-Halton exact tests were used to analyze the data. Cohen's d and dz formulas were used to calculate the effect sizes. MI sessions were held every two weeks in IG. No intervention was applied in CG. Significant progress was found in the change stages of IG compared to CG. The mean of step counts was significant in favour of IG, and the effect size was d=0.641. PASE total score increased significantly in IG, and the effect size was dz=0.202. This trial indicated that after the TTM-based MI, the change stages of the older adults improved, and their exercising behaviours promoted. In conclusion, TTM and MI are recommended to be used by the nurses toimprove healthy lifestyle behaviours in older adults, and studies to increase physical activity levels in this population should be conducted for a longer period, and studies with larger sample groups are recommended.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2019

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

October 11, 2019

Last Update Submit

July 27, 2022

Conditions

Keywords

older adultmotivational interviewingTranstheoretical modelphysical activitynursing

Outcome Measures

Primary Outcomes (1)

  • Measurement of stages of change

    The transtheoretical model construes change as a process involving progress through a series of five stages. Precontemplation is the stage in which people are not intending to take action in the foreseeable future, usually measured as the next 6 months. Contemplation is the stage in which people are intending to change in the next 6 months. Preparation is the stage in which people are intending to take action in the immediate future, usually measured as the next month. Action is the stage in which people have made specific overt modifications in their life styles within the past 6 months. Maintenance is the stage in which people are working to prevent relapse but they do not apply change processes as frequently as do people in action. It is expected that there will be progress in the levels of stages of change exercise behaviors of the elderly who have been conducted motivational interviews based on transtheoretical model.

    Twenty-five weeks

Secondary Outcomes (2)

  • Assessment of physical activity level-Physical Activity Scale for the Elderly

    Twenty-five weeks

  • Assessment of physical activity level-Pedometer monitoring

    Twenty-five weeks

Study Arms (2)

Intervention motivational interview group

EXPERIMENTAL

Face-to-face motivational interviews lasted for an average of 30 minutes. After the MI, the exercise information guideline prepared by the researcher and the TTM-based MI guideline according to the stages were given to the older adults. During the MI, a form prepared by the researcher was used to note the content of the interview. At the end of MI, the next appointment was planned. In addition, the older adults were given a chart prepared by the researcher to note their walk. On the other hand, the phone-based motivation interviews lasted an average of five to seven minutes. Before the telephone interview, it was determined which stage of change the older adult was in. Then a motivational interview was held according to the stage.

Behavioral: Intervention motivational interview group

Control

NO INTERVENTION

The Control Group (CG) was only followed up at the beginning and end of the study, no intervention was made. The CG received standard care. Although the family health staff do not give routine and standard training about the benefits of exercising in the FHC to the elderly, they give information when necessary.

Interventions

Motivational interviewing (MI) a client-centered, goal-oriented method for enhancing intrinsic motivation to change by exploring and resolving ambivalence. Motivational interviewing is underpinned by a series of principles that emphasise a collaborative therapeutic relationship in which the autonomy of the patient is respected and the patient's intrinsic resources for change are elicited by the therapist. In the present study, an effort was made to help the IG to realize the dilemmas of individuals in the precontemplation stage about exercising, and individuals in the contemplation stage to produce their own solutions. In this direction, techniques such as decision balance, importance, and trust technique were applied, thus enabling them to reveal their feelings, thoughts, and reactions regarding the benefits/harms of doing/not doing exercise. They were supported to raise awareness about the consequences and solutions of the causes.

Intervention motivational interview group

Eligibility Criteria

Age65 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • aged seniors, who will voluntarily participate in the study
  • Seniors, at least literate or elementary school graduated
  • Seniors, at the pre-contemplation or contemplation stages of exercise behavior change
  • No cognitive impairment which affects the interpersonal communication
  • No muscle-joint problems to be a barrier for the physical activity
  • No neuropsychiatric disorder

You may not qualify if:

  • Individuals whose age are less than 65 and bigger than 75.
  • Seniors whose Mini Mental State Test (MMT) scores under 24 points (Mild Cognitive Impairment)
  • Seniors whose Geriatric Depression Scale (GDS) scores above 5 points
  • Seniors diagnosed with Cancer, Insulin-dependent Type-2 Diabetes Mellitus, Uncontrolled-Hypertension, Heart Failure, Chronic Obstructive Pulmonary Disease (COPD) and Asthma
  • Termination Criteria:
  • Termination criteria are changing in the mental status of the senior during the follow-ups, requesting for leaving the research at any stage and any situation that requires hospitalization needs of the senior.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Yeter KİTİŞ, Prof.

    Gazi University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
No researcher and participant blindness were performed. The data were collected and recorded by an independent researcher who was trained by the researcher and did not know the groups. The statistics were performed by an independent statistician.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 11, 2019

First Posted

October 16, 2019

Study Start

April 20, 2019

Primary Completion

November 20, 2019

Study Completion

November 20, 2019

Last Updated

August 1, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

It has not yet been decided with the responsible investigator whether the IPD will be shared.

Locations