Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001261707
Ethics application status
Approved
Date submitted
13/09/2022
Date registered
21/09/2022
Date last updated
2/05/2024
Date data sharing statement initially provided
21/09/2022
Date results information initially provided
2/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Comparison of Goal-Oriented Guided Mental Imagery versus Goal Setting Interventions on Physical Activity Levels in Young, Inactive Adults with Overweight or Obesity Living in Australia
Scientific title
A Comparison of Goal-Oriented, Guided Imagery versus SMART Goal Setting Interventions on Physical Activity Levels in Young, Inactive Adults with Overweight or Obesity: A Randomised Controlled Trial Pilot Study
Secondary ID [1] 307772 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
overweight 327347 0
obesity 327663 0
Condition category
Condition code
Public Health 324474 324474 0 0
Health promotion/education
Diet and Nutrition 324747 324747 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Goal -oriented guided imagery

Materials:
Participants in the goal-oriented guided mental imagery condition will be provided with imagery script recordings (audio) and an information sheet to explain how to perform guided mental imagery. The current study will utilise a modified version of Giacobbi and colleagues’ (2018) guided imagery script. The current study has two imagery scripts: a cardiorespiratory exercise script (practised at least four times a week) and a resistance training script (practised at least twice a week) The recording of the first imagery script (3 minutes 25 seconds) focuses on performing cardiorespiratory exercise and the recording of the second script (3 minutes 38 seconds) requests participants to create vivid and realistic images relating to resistance training. Participants will also be given a general exercise imagery script to allow for modification of the specific cardiorespiratory activities they could imagine while maintaining the following five specific scenarios: (1) imagining a place to exercise; (2) a slow-paced warm-up exercise of the participants’ choice; (3) images of a progressively more intense exercise; (4) imagining oneself coping with a vigorous activity; and (5) images encouraging participants to monitor exercise technique. Participants will be asked to perform guided mental imagery in a quiet environment prior to commencing the exercise. Participants will be asked to record if they had performed guided imagery each day in the online logbook provided by the researcher.

All participants will receive by mail a set of two resistance bands, comprising two resistance levels (light and medium) to be used for the resistance exercise sessions during the 6-week exercise program. Participants will also be asked to complete an online logbook, specifically designed for participants to log their cardiorespiratory exercise session length (time) and their ratings of perceived exertion, which will be used to calculate their metabolic equivalent of task (MET).

All participants will receive an information sheet specifically designed on types of cardiorespiratory exercise routines they might follow. This will ensure that participants have the autonomy to incorporate their preferred modes of cardiorespiratory exercise over the 6-week intervention.



Procedure:

Baseline testing
Participants who are safe to proceed (or have subsequently provided medical approval to proceed) will attend a second, one-to-one virtual meeting (one hour duration) for baseline testing. During the baseline testing session, they will be tested on their muscular endurance. Muscular endurance will be assessed both pre- (baseline) and post-training (after the 6-week exercise program). The muscular endurance tests will comprise four types of exercise: (1) isometric, squat hold, (2) prone bridge hold, (3) push-ups to failure, and (4) curl-ups to failure.

Participants will be allocated to either one of the two interventions

Moderate intensity cardiorespiratory exercise should be performed at least four days a week, at any time of the day, for at least 30 minutes per session. Participants can engage in their own choice of cardio such as cycling, jogging, walking, or running. Participants will receive reminders to complete their cardiorespiratory exercise via Outlook. The reminders will include the type of exercise participants had opted for initially and their goals (either audio or written) to be reviewed prior to performing their exercise individually. The moderate-intensity cardiorespiratory exercise intensity will be measured using the metabolic equivalent of task minutes and Borg RPE


The resistance training program will include two training sessions per week (12 sessions in total over six weeks) lasting 30 minutes each. These sessions will be split into two, three-week blocks over six weeks delivered by the researcher. The resistance exercise sessions( Ee.g., Neutral Grip Band Biceps curls, Diagonal Band pull apart) will progressively become more difficult as the participants adapt to the initial training stimuli.


Who will deliver the program?
The student investigator will deliver the program. The student investigator is accredited with level one strength and conditioning.

Mode of delivery:
The 6-week exercise program is delivered over the internet. The program is supported by telehealth.
For both the initial and baseline testing, participants will have their virtual meeting the student investigator individually via Microsoft Teams. The resistance training will be conducted in groups of 5-6.

Number of times the intervention will be provided (Duration, intensity, dose of intervention):

Participants allocated to goal oriented guided imagery would be given a cardiorespiratory exercise script (practiced at least four times a week) and resistance training script (practiced at least twice a week), amounting to participants using guided imagery six times per week in total, equivalent to the goal setting condition. Participants will be asked to complete the guided imagery sessions 5 minutes prior to each exercise session. Participants will not be asked to aim for a target RPE for these exercises.

Participants allocated to goal setting condition will be asked to read their goals at least 6 days out of 7 days in a week.

Participants both allocated to goal oriented guided imagery or goal setting condition will be exposed to cardiorespiratory exercise, which would be performed at least four days a week, at any time of the day, for at least 30 minutes per session. The resistance training would be twice a week (12 sessions in total over six weeks) lasting 30 minutes each. Participants will be asked to complete the guided imagery sessions just before the resistance training session.

Location

The cardiorespiratory exercise would be performed by the participants their own at their place of choice.

The resistance exercise sessions will be conducted over a group videoconference call by the researcher (Microsoft Teams) at a pre-scheduled time; hence all these workouts will be performed online, at participants’ place of choice. The

intervention is personalised:
Participants allocated to goal-oriented guided imagery will be given a general exercise imagery script to allow for modification of the specific cardiorespiratory or resistance training activities.

The resistance exercise sessions will progressively become more difficult as the participants adapt to the initial training stimuli. Following the initial training week, which will be deliberately sub-maximal and relatively low in intensity, we will aim to make the level of difficulty for each exercise approximately 7 out of 10 on the RPE scale. This is to ensure the resistance training sessions are challenging and provide appropriate adaptation. To achieve this, the repetitions (reps) and sets will be progressively overloaded until each participant reaches a maximum volume of three sets for 15 repetitions. Based on previous experience, once a participant performs more than three sets of 15 repetitions per set, boredom quickly sets in. Thus, once the maximum reps and sets volume has been achieved, there will be an incremental change of resistance bands (e.g., change from light to medium). For the resistance training sessions, the researcher will use the participants’ RPE scores for each exercise to adjust the number of reps either up or down by two. If the RPE was rated 9 or above, then the number of reps would be reduced by two reps. If the RPE was rated 7 or below, then the number of reps would be increased by two reps. If the participant was only able to complete the minimum target and had an RPE of 9 or more, then their number of reps would not be changed until their RPE score was 7 or below. The minimum exercise target is three sets of each exercise, and there are 10 exercises altogether. Muscular endurance is expected to change over the course of the resistance training program.

Strategies for improving adherence:
The student investigator will have weekly check-in sessions with each participant via video-conference calls in Microsoft Teams to ensure they adhere to the exercise programme and continue to receive support through feedback on their activity level.

Participants will also receive reminders via Outlook for their cardiorespiratory and resistance training.

Intervention code [1] 324234 0
Treatment: Other
Intervention code [2] 324450 0
Behaviour
Comparator / control treatment
Goal Setting Intervention. The participants in the goal-setting condition will be provided with two ‘SMART’ goal phrases. The two goals will be used to measure adherence to the exercise program and overall improvements made regarding physical activity over the six-week exercise program. Participants will be asked to read their goals at least six days out of seven days a week. Participants will be asked to view their goals for the day prior to exercising.


The participants in the goal-setting condition will be provided with two ‘SMART’ goal phrases. Each goal phrase will be written by the researcher to be Specific, Realistic, Achievable, Measurable, Time-bound, and relevant to the exercise program. Participants will be asked to record their goals and if they completed the daily goal in the online logbook provided, to track their goal setting and adherence. The SMART goal for the cardiorespiratory activity will be, “I will perform at least 150 minutes of moderate-intensity physical activity per week”. The SMART goal for resistance training will simply be, “I will perform half an hour of all resistance training set by the trainer for today’s session”.

The participant in goal setting condition will also will also undergo both the cardiorespiratory and resistance exercise sessions following the same schedule as the 'guided imagery' intervention arm.
Control group
Active

Outcomes
Primary outcome [1] 332301 0
Any change in physical activity will be assessed data recorded using an online logbook via Qualtrics. As this outcome appears to be assessed using a combination of mode of exercise, duration of exercise, and intensity of exercise using ratings of perceived exertion via Qualtrics. These details will enable the researchers to convert all cardiorespiratory exercise and resistance training sessions into Metabolic equivalent of task (MET) and metabolic minutes per week (which will be used to quantify physical activity levels each week). During resistance training, the research will take note of the participants’ perceived exertion for respiratory exercise for each exercise. This assessed outcome is the composite primary outcome.
Timepoint [1] 332301 0
The cardio will be assessed for 4 days a week and the resistance will be assessed twice weekly throughout the 6 weeks.
After each cardiorespiratory exercise session, Rating of perceived exertion (RPE) scale for cardiorespiratory exercise (Foster et al., 2001) will be utilised. In resistance training, the research will take note of the participants’ perceived exertion for respiratory exercise using OMNI-Resistance Exercise Scale (OMNI-RES) Robertson et al., 2003) for each exercise.

Secondary outcome [1] 412901 0
Motivation to exercise will be assessed using The Exercise Motivation Scale (The Exercise Motivation Scale (EMS), Li, 1999). The scale consists of 31 items, with eight subscales that measure the ‘exercise motivation’ construct ranging along the self-determination continuum: amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, intrinsic motivation to learn, intrinsic motivation to accomplish tasks, and intrinsic motivation to experience sensations.
Timepoint [1] 412901 0
It will be assessed both pre- (baseline) and post-training (after the 6-week exercise program).
Secondary outcome [2] 412903 0
Levels of enjoyment will be assessed using the Physical Activity Enjoyment Scale (PACES)(Kendzierski & DeCarlo, 1991). scale measures enjoyment of the session and includes 18 items, measured on a 7-point scale.
Timepoint [2] 412903 0
It will be assessed both pre- (baseline) and post-training (after the 6-week exercise program).
Secondary outcome [3] 412904 0
Exercise imagery will be assessed using Exercise Imagery Inventory-Revised Imagery (Exercise Imagery Inventory-Revised (EII-R), Giacobbi et al., 2010). EII-R consists of five subscales that measure exercise technique, routines (cognitive imagery), fitness and health outcomes, feelings associated with exercise, and images of self-efficacy (motivational imagery).
Timepoint [3] 412904 0
It will be assessed both pre- (baseline) and post-training (after the 6-week exercise program).
Secondary outcome [4] 412905 0
Muscular endurance using Muscular Endurance Test, which is specifically designed for the current study. The muscular endurance tests will comprise four types of exercise: (1) isometric, squat hold, (2) prone bridge hold, (3) push-ups to failure, and (4) curl-ups to failure. All tests scores will be assessed as a composite secondary outcome
Timepoint [4] 412905 0
It will be assessed both pre- (baseline) and post-training (after the 6-week exercise program).
Secondary outcome [5] 412906 0
Overall adherence to the exercise program will be assessed using International Physical Activity Questionnaire (Craig et al., 2003).These questions will ask respondents how much time they spent being physically active in the last 7 days.
Timepoint [5] 412906 0
It will be assessed both pre- (baseline) and post-training (after the 6-week exercise program).
Secondary outcome [6] 412907 0
The feasibility and acceptability of the intervention will be assessed using questions relating to their experience over the 6-week exercise program via telehealth. The group/ individual interview is conducted to will be used to gather information about the goal-oriented guided mental imagery group and goal-setting group. It is particularly important to comprehend the concerns and investigate the positive outcomes of both conditions. The interview will be conducted via video or audio using the online communication platform Microsoft Teams. Participants may choose the method of remote delivery (video or audio-only) using this platform.
Timepoint [6] 412907 0
One week post-completion of the 6-week exercise program.

Eligibility
Key inclusion criteria
Participants eligible for the trial must comply with all the following criteria at randomisation:
• men between the ages of 18 and 34 years;
• overweight or obese but classified within only the following four Body Mass Index (BMI) categories: (a) Overweight – BMI greater than or equal to 25 to 29.9 kg/m^2; (b) Obesity – BMI greater than or equal to 30 kg/m^2; (c) Obesity class I – BMI 30 to 34.9 kg/m^2; or (d) Obesity class II – BMI 35 to 39.9 kg/m^2.
• individuals who fall under ‘low/moderately active’ in the physical activity category of the International Physical Activity Questionnaire;
• Male participants will be excluded if their waist circumference is less than 99 or greater than 125. Female participants will be excluded if their waist circumference is less than 80 or greater than 110.
• Adults residing in Australia;
no mobility impairment;
• free for at least six months of musculoskeletal injury requiring medical or allied health intervention or treatment; and
• free of ongoing use of pain medication for more than two episodes of one week, based on advice from allied health professional.
Minimum age
18 Years
Maximum age
34 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded based on the following
Obesity category class III includes morbidly obese individuals who are associated with very high risk of comorbidities, hence this class is excluded to ensure protection of individuals from potential harm.
In addition:
6) Participants will be excluded based on mobility impairment.
7) Participants will be excluded if they are not at least 6 months free of musculoskeletal injury requiring medical or allied health intervention or treatment; and free of ongoing use of pain medication for more than 2 episodes of one week as suggested by an allied health professional

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation ratio (i.e., the proportion of participants in each condition) is designed to be the same across both groups (i.e., 1:1). The protocol author will generate an identification number using the random number generator in Statistical Package for the Social Sciences (SPSS). This strategy utilises a process in which the randomisation sequence is unknown to the participants until they are assigned to the group. The researcher will assign the identification number to each participant. There will be no blinding of the researcher as all these roles will be performed by the protocol author. However, the researcher will ensure that the treatment of groups is standardised and will be using objective, reliable outcomes to assess the interventions.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
BMI, waist circumference, age and Depression Anxiety Stress Scale (DASS) will be used as covariates, to account for the effects of these variables in all analyses. A p-value of 0.05 (two-tailed) is adopted for all analyses. Hypotheses stated previously will be tested via a series of ANCOVAs and statistically significant effects from ANCOVAS will be followed up with simple effects analyses. To address the specific hypotheses the following analysis will be employed:
1. Achieve greater adherence to cardiorespiratory activity based on logbook entries (e.g., at least 150 minutes of moderate-intensity physical activity each week over six weeks).
2. Achieve greater adherence to resistance training sessions based on attendance (e.g., complete at least two resistance exercise sessions per week over six weeks).
3. Demonstrate a greater magnitude of improvement in their muscular endurance results (i.e., muscular endurance pre-baseline and post-week six assessment).
4. Demonstrate a greater magnitude of increase in physical activity levels (metabolic equivalents [MET] minutes) across the six-week training intervention based on logbook entries throughout the six weeks.
5. Attain greater intrinsic motivation based on the ‘Exercise Motivation Scale’ and experience a greater level of physical activity enjoyment based on the ‘Physical Activity Enjoyment Scale' (show an increase from pre- to post-the six-week program).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/08/2022
Date of last participant enrolment
Anticipated
31/01/2023
Actual
29/12/2023
Date of last data collection
Anticipated
14/04/2023
Actual
30/01/2024
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312047 0
University
Name [1] 312047 0
Swinburne University
Country [1] 312047 0
Australia
Primary sponsor type
University
Name
Swinburne university
Address
John St, Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 313551 0
None
Name [1] 313551 0
Address [1] 313551 0
Country [1] 313551 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311455 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [1] 311455 0
John St, Hawthorn VIC 3122
Ethics committee country [1] 311455 0
Australia
Date submitted for ethics approval [1] 311455 0
10/12/2021
Approval date [1] 311455 0
15/12/2021
Ethics approval number [1] 311455 0
20215672-8999

Summary
Brief summary
The prevalence of overweight and obesity in young men is increasing as physical activity levels decline, suggesting strategies to promote and enhance physical activity levels should be improved. Goal-oriented guided mental imagery is a technique that we believe may enhance physical activity levels among overweight and obese young male adults. It has been shown to be an effective strategy to enhance physical activity among women with overweight and obesity, compared to observing set written goals. Therefore, the purpose of this study is to compare the efficacy of goal-oriented guided mental imagery and traditional goal-setting techniques for increasing physical activity levels among inactive overweight and obese young male adults. This study will compare the effects of these interventions on exercise compliance (prescribed cardiorespiratory exercise and strength training sessions), weekly physical activity levels, intrinsic motivation, enjoyment of exercise, and muscular endurance during a 6-week telehealth exercise program. Focus group data will be collected at the end of the program to obtain qualitative feedback on the feasibility and sustainability of the interventions and exercise program for future use.

The research question for this study was derived using the acronym PICO (Population, Intervention, Comparison, Outcome).


The research question is: Does goal-oriented guided mental imagery provided to young inactive overweight or obese male adults result in increased physical activity levels compared to setting goals alone?
We hypothesize that compared to the goal-setting group, participants in the goal-oriented guided mental imagery group will:
1. Achieve greater adherence to cardiorespiratory activity based on logbook entries (e.g., at least 150 minutes of moderate-intensity physical activity each week over 6 weeks);
2. Achieve greater adherence to resistance training sessions based on logbook entries (e.g., complete at least two resistance exercise sessions per week over 6 weeks);
3. Have a greater magnitude of improvement in their muscular endurance results (i.e., muscular endurance pre- and post-assessment);
4. Have a greater magnitude of increase in physical activity levels (metabolic equivalents [MET] minutes) across the 6-week training intervention based on logbook entries.
5. Attain greater intrinsic motivation based on the ‘Exercise Motivation Scale’ and experience a greater level of physical activity enjoyment based on the ‘Physical Activity Enjoyment Scale'.

Trial website
Trial related presentations / publications
Public notes
Eligible participants will be invited to join a virtual meeting (on Microsoft Teams) with the student researcher to complete an initial assessment for the purpose of confirming eligibility to participate.
participants will be asked to provide their demographic information and complete the Adult Pre-Exercise Screening System (APSS; Norton, 2012) questionnaire, which measures (1) the individual’s current level of physical activity, (2) the presence of signs or symptoms and/or known cardiovascular, metabolic, or renal disease, and (3) desired exercise intensity. Participants will also complete the International Physical Activity Questionnaire (IPAQ; (Craig et al., 2003) which measures the amount of time spent being physically active in the last seven days.

Contacts
Principal investigator
Name 121154 0
Ms Tharushini Anandam
Address 121154 0
Swinburne University of Technology
John Street
Hawthorn 3122 VICTORIA
Australia
Country 121154 0
Australia
Phone 121154 0
+61402742771
Fax 121154 0
Email 121154 0
tanandam@swin.edu.au
Contact person for public queries
Name 121155 0
Miss Tharushini Anandam
Address 121155 0
Swinburne University of Technology
John Street
Hawthorn 3122 VICTORIA
Australia
Country 121155 0
Australia
Phone 121155 0
+61402742771
Fax 121155 0
Email 121155 0
tanandam@swin.edu.au
Contact person for scientific queries
Name 121156 0
Miss Tharushini Anandam
Address 121156 0
Swinburne University of Technology
John Street
Hawthorn 3122 VICTORIA
Australia
Country 121156 0
Australia
Phone 121156 0
+61402742771
Fax 121156 0
Email 121156 0
tanandam@swin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16931Ethical approval  tanandam@swin.edu.au 384524-(Uploaded-16-08-2022-13-31-57)-Study-related document.pdf
16933Informed consent form  tanandam@swin.edu.au 384524-(Uploaded-13-09-2022-14-45-12)-Study-related document.docx



Results publications and other study-related documents

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