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Effectiveness of a Brief Internet-delivered Behaviour Change Intervention Among Healthy Middle-aged Adults

NCT ID: NCT05033184

Last Updated: 2023-12-07

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-08-31

Brief Summary

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Previous studies have demonstrated the need to move beyond the common misconception of midlife as a time of crisis so that further understandings of the midlife as a time of opportunity for the maintenance and improvement of health can be developed. Several psychosocial factors such as resilience, emotion regulation, perceived social support, and control beliefs have been identified as having a role in the adoption of healthier lifestyle habits in middle age which, in turn, may decrease the risk of a developing or worsening chronic disease. Several behaviour change interventions have also been proposed in the literature. As Canada's population ages, it is important that brief behaviour change interventions, and the psychosocial factors that facilitate such behaviour changes, be identified as a way to promote better health during the midlife years so as to improve the experience of aging. The present study is aimed at evaluating the influence of psychosocial factors on the adoption of healthy lifestyle habits. Specifically, this study aims to examine whether differing experiences of social support, resilience, emotion regulation, and control beliefs influence physical activity levels following a brief behaviour change intervention. Participants will be asked to complete a demographics questionnaire followed by a series of measures to determine the individual's perceived levels of social support, resilience, emotion regulation, and control beliefs. After completing this set of questionnaires, participants will be randomly assigned to either an experimental or a control condition. Participants in the experimental condition will be asked to complete the Brief Action Planning exercise as a way to identify a goal related to health behaviours. Participants in the control condition will be asked to identify a goal related to health behaviours without being introduced to the Brief Action Planning exercise. Two weeks and four weeks following this intervention, individuals will be asked to indicate the degree to which they were able to achieve their health goal. It is expected that individuals in the experimental condition will experience greater improvement in physical activity levels compared to individuals in the control condition. The investigators also anticipate that improvements in physical activity levels in the experimental condition will be influenced by the psychosocial factors of social support, resilience, emotion regulation, and control beliefs. The potential significance of this study includes increasing awareness of the influence of psychosocial factors on health behaviours and the possible effectiveness of a brief behaviour change intervention among middle-aged adults. Potential interventions may be used in clinical settings or community programs in which middle-aged adults engage.

Detailed Description

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Conditions

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Health Behavior

Keywords

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Physical Activity Control Beliefs Emotion Regulation Resilience Social Support

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Brief Action Planning Exercise

Group Type EXPERIMENTAL

Brief Action Planning Exercise

Intervention Type BEHAVIORAL

The Brief Action Planning exercise is a previously developed goal-setting exercise which has been designed to incorporate aspects of motivational interviewing such as compassion, acceptance, evocation, and partnership. It is a tool that allows participants to identify an aspect of their life they would like to improve upon and guides them through the process of making a specific, measurable, achievable, realistic, and timely (SMART) goal. It also assesses their confidence in achieving this goal so as to assist with making alternative plans if confidence is low.

Goal Setting Exercise

Group Type ACTIVE_COMPARATOR

Goal Setting Exercise

Intervention Type BEHAVIORAL

The Goal Setting exercise allows participants to identify an aspect of their life they would like to improve upon without incorporating aspects of motivational interviewing components or providing any guidance on how to set this goal.

Interventions

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Brief Action Planning Exercise

The Brief Action Planning exercise is a previously developed goal-setting exercise which has been designed to incorporate aspects of motivational interviewing such as compassion, acceptance, evocation, and partnership. It is a tool that allows participants to identify an aspect of their life they would like to improve upon and guides them through the process of making a specific, measurable, achievable, realistic, and timely (SMART) goal. It also assesses their confidence in achieving this goal so as to assist with making alternative plans if confidence is low.

Intervention Type BEHAVIORAL

Goal Setting Exercise

The Goal Setting exercise allows participants to identify an aspect of their life they would like to improve upon without incorporating aspects of motivational interviewing components or providing any guidance on how to set this goal.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Residing in Saskatchewan, Canada
* Between the ages of 35 and 64 years
* Deemed eligible to increase physical activity levels by the Physical Activity Readiness Questionnaire for Everyone (Par-Q+; Canadian Society for Exercise Physiology, 2019)

Exclusion Criteria

* Residing outside of Saskatchewan, Canada
* Under the age of 35 years or over the age of 64 years
* Deemed ineligible to increase physical activity levels by the Physical Activity Readiness Questionnaire for Everyone (Par-Q+; Canadian Society for Exercise Physiology, 2019)
Minimum Eligible Age

35 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Regina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natasha L Gallant, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Regina

Locations

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University of Regina

Regina, Saskatchewan, Canada

Site Status

Countries

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Canada

References

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Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

Reference Type BACKGROUND
PMID: 12900694 (View on PubMed)

Warburton DER, Jamnik VK, Bredin SSD, Gledhill N on behalf of the PAR-Q+ Collaboration. The Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) and Electronic Physical Activity Readiness Medical Examination (ePARmed-X+). Health & Fitness Journal of Canada. 2011; 4(2): 3-23.

Reference Type BACKGROUND

Infurna FJ, Gerstorf D, Lachman ME. Midlife in the 2020s: Opportunities and challenges. Am Psychol. 2020 May-Jun;75(4):470-485. doi: 10.1037/amp0000591.

Reference Type BACKGROUND
PMID: 32378943 (View on PubMed)

Lachman ME, Teshale S, Agrigoroaei S. Midlife as a Pivotal Period in the Life Course: Balancing Growth and Decline at the Crossroads of Youth and Old Age. Int J Behav Dev. 2015 Jan 1;39(1):20-31. doi: 10.1177/0165025414533223.

Reference Type BACKGROUND
PMID: 25580043 (View on PubMed)

Gutnick D, Reims K, Davis C, Gainforth H, Jay M, Cole S. Brief action planning to facilitate behavior change and support patient self-management. Journal of Clinical Outcomes Management. 2014; (21)1: 17-29.

Reference Type BACKGROUND

Other Identifiers

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2021-074

Identifier Type: -

Identifier Source: org_study_id