Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001070729
Ethics application status
Approved
Date submitted
27/07/2022
Date registered
2/08/2022
Date last updated
20/07/2023
Date data sharing statement initially provided
2/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
TEXT4HealthyHeart - texting for Cardiac Rehabilitation
Scientific title
The effect of a text message program (TEXT4HealthyHeart) on reducing overweight and obesity for adults referred to the Shoalhaven Cardiac Rehabilitation Program.
Secondary ID [1] 307663 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease 327189 0
Cardiovascular Event 327190 0
Cardiac Rehabilitation 327191 0
Overweight 327203 0
Obesity 327204 0
Condition category
Condition code
Cardiovascular 324326 324326 0 0
Coronary heart disease
Cardiovascular 324327 324327 0 0
Normal development and function of the cardiovascular system
Public Health 324342 324342 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project examines the effect of a text message program (TEXT4HealthyHeart) on reducing overweight and obesity for people referred to a Cardiac Rehabilitation Program (CRP). Despite the established health benefits of CRP participation, the majority of people with cardiovascular diseases are overweight and inactive. Furthermore, not all of those referred to a CRP after a cardiovascular event choose to participate. A review of interventions designed to ameliorate this trend revealed the use of text message programs which have shown beneficial outcomes for people with coronary heart disease (CHD).

Participants will receive specifically selected automatic daily text messages for 6 months on weight reduction, nutrition and physical activity, which have been developed in previous studies. Text messages will take less than a minute to read, and replies will not be received however participants will be able to discuss any relevant matters with their Cardiac Rehabilitation CNC. Participants will also receive a step recording calendar and will be supplied with a step counting device if they do not have one. Objective and self-report measures will be collected directly from the participant at baseline, 3 months and at 6 months.

The delivery of the text messages as well as collection of objective data will be overseen by the site CRP Clinical Nurse Consultant (CNC), who has specific expertise and training in cardiac rehabilitation programs.
Intervention code [1] 324130 0
Rehabilitation
Intervention code [2] 324131 0
Prevention
Intervention code [3] 324132 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332132 0
Change in Weight, measured on digital scales
Timepoint [1] 332132 0
Baseline, 3 and 6 months (primary endpoint) post-commencement of intervention
Primary outcome [2] 332134 0
Acceptability of the text message program via a study-specific questionnaire
Timepoint [2] 332134 0
3 and 6 months (primary endpoint) post-commencement of intervention
Primary outcome [3] 332135 0
Change in level of physical activity as measured through a step counter and activity diary, plus recorded responses in study-specific questionnaire
Timepoint [3] 332135 0
Baseline, 3 and 6 months (primary endpoint) post-commencement of intervention
Secondary outcome [1] 412318 0
Change in waist circumference, measured by tape measure (this is a primary outcome)
Timepoint [1] 412318 0
Baseline, 3 and 6 months (primary endpoint) post-commencement of intervention
Secondary outcome [2] 412362 0
Change in BMI - height measured with stadiometer and weight on digital scales (this is a primary outcome)
Timepoint [2] 412362 0
Baseline, 3 and 6 months (primary endpoint) post-commencement of intervention
Secondary outcome [3] 412363 0
Change in blood pressure as measured by CRP CNC or with home blood pressure device (method of measurement also recorded) (this is a primary outcome).
Timepoint [3] 412363 0
Baseline, 3 and 6 months (primary time point) post-commencement of intervention
Secondary outcome [4] 412472 0
Change in nutrition habits, measured as the recorded responses in study-specific questionnaire (this is a primary outcome
Timepoint [4] 412472 0
Baseline, 3 and 6 months (primary time point) post-commencement of intervention

Eligibility
Key inclusion criteria
• People referred to the study CRP
• People greater than or equal to 18 years of age
• People who are able to read and understand a text message
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• People referred to the CRP who reside outside of the Local Health District and cannot attend the study site CRP
• People for whom exercise is medically contraindicated until medical exercise clearance consent is granted
• People who live in a residential aged care facility
• People with significant cognitive impairment due to factors such as dementia, mental illness and intellectual disability.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will in the first instance be assessed descriptively using means, medians, percentages and frequencies for categorical data, along with means and standard deviations for continuous data.
Further statistical evaluation will be conducted where deemed appropriate upon encountering the data using inter alia, regression analysis for correlation and likelihood ratios

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/08/2022
Actual
18/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
227
Accrual to date
47
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311932 0
Government body
Name [1] 311932 0
Illawarra Shoalhaven Local Health District
Country [1] 311932 0
Australia
Primary sponsor type
Government body
Name
Illawarra Shoalhaven Local Health District
Address
67-71 King Street District Executive Office Suite 2, Level 2, Warrawong NSW 2505
Country
Australia
Secondary sponsor category [1] 313413 0
None
Name [1] 313413 0
Address [1] 313413 0
Country [1] 313413 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311365 0
Illawarra Shoalhaven Local Health District Low & Negligible Risk Review Committee
Ethics committee address [1] 311365 0
67-71 King Street District Executive Office Suite 2, Level 2, Warrawong NSW 2505
Ethics committee country [1] 311365 0
Australia
Date submitted for ethics approval [1] 311365 0
30/06/2022
Approval date [1] 311365 0
01/07/2022
Ethics approval number [1] 311365 0
ISLHD/LNR/2022-188

Summary
Brief summary
This study aims to test the acceptability and feasibility of a text message program (TEXT4HealthyHeart) on reducing overweight and obesity for people referred to the Shoalhaven CRP, as well as to assess the preliminary effect of TEXT4HealthyHeart on body mass index (BMI), waist circumference, blood pressure, heart rate, nutrition and physical activity including step count.
Participants will receive specifically selected automatic daily text messages for 6 months on weight reduction, nutrition and physical activity. They will also receive a step recording calendar and will be supplied with a step counting device if they do not have one. Objective and self-report measures will be collected directly from the participant at baseline, 3 months and at 6 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120842 0
Ms Rachael Turner
Address 120842 0
Nowra Community Health Centre,
5-7 Lawrence Ave, Nowra NSW 2541
Country 120842 0
Australia
Phone 120842 0
+61 02 4424 6387
Fax 120842 0
Email 120842 0
Rachael.Turner1@health.nsw.gov.au
Contact person for public queries
Name 120843 0
Ms Rachael Turner
Address 120843 0
Nowra Community Health Centre,
5-7 Lawrence Ave, Nowra NSW 2541
Country 120843 0
Australia
Phone 120843 0
+61 02 4424 6387
Fax 120843 0
Email 120843 0
Rachael.Turner1@health.nsw.gov.au
Contact person for scientific queries
Name 120844 0
Ms Rachael Turner
Address 120844 0
Nowra Community Health Centre,
5-7 Lawrence Ave, Nowra NSW 2541
Country 120844 0
Australia
Phone 120844 0
+61 02 4424 6387
Fax 120844 0
Email 120844 0
Rachael.Turner1@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not necessary for this trial and release of individual records not approved under ethics


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16749Study protocol  ISLHD-ResearchGovernance@health.nsw.gov.au
16750Informed consent form  ISLHD-ResearchGovernance@health.nsw.gov.au
16751Ethical approval  ISLHD-ResearchGovernance@health.nsw.gov.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.