Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619001111167
Ethics application status
Approved
Date submitted
1/08/2019
Date registered
12/08/2019
Date last updated
12/08/2019
Date data sharing statement initially provided
12/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
EatSmart: Supporting healthy eating on a budget among people with Type 2 diabetes
Scientific title
Feasibility and effects on fruit and vegetable intakes of EatSmart, an eHealth intervention supporting healthy eating on a budget among people with Type 2 diabetes
Secondary ID [1] 298864 0
Nil
Universal Trial Number (UTN)
U1111-1237-7038
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 313821 0
Condition category
Condition code
Metabolic and Endocrine 312227 312227 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a 12-week web- and text-based program providing theory- and evidence-based behaviour change support for heathy eating. The approach is informed by Social Cognitive Theory (Bandura, 2004) and builds on previous work by the investigators (e.g. Ball et al., AJCN 2016). It was designed by the investigatory team, who have research expertise in behaviour change, dietetics, diabetes care, and technology-delivered interventions, and utilised input from clinicians (Endocrinologists, Diabetes Nurse Educators) and from people living with Type 2 diabetes.
The program is designed to provide participants with skills and knowledge related to healthy food purchasing and preparation, including budgeting, menu/meal-planning, food shopping tips, and cooking/meal preparation skills. It targets the following determinants of diet: knowledge and skills; self-efficacy/confidence; and perceived barriers (budget/affordability, family preferences, time, taste, skills). It engages participants in effective behaviour change techniques, including setting goals for purchasing and consuming key food groups; self-monitoring consumption; engaging social support from family and friends; and problem-solving key barriers to healthy eating.
Participants will have access to the trial website, which includes six skill-based modules (covering areas including how to make a healthy eating plan; smart food shopping; time saving meal strategies; food storage, cooking, reducing waste; and modifying recipes). Access to the modules will be provided sequentially, on a two-weekly basis. Over the three month intervention, participants will also receive three text messages/week (36 in total) which provide support, feedback and encouragement to review goals, continue to engage with different components of the website and eat healthily.
There may be interaction between participants or between participants and clinicians, only as part of usual care during the intervention period (ie not an intervention component).
Engagement with the program will be assessed as a marker of fidelity via both self-report survey items and through website analytics (logins, duration of use).
Intervention code [1] 315130 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320874 0
Daily fruit consumption assessed by a short dietary intake question, adapted from that used in Australia's National Nutrition Survey (1995), which was shown to discriminate between groups with different fruit intakes assessed by 24-h recall
Timepoint [1] 320874 0
Baseline and week 12
Primary outcome [2] 320875 0
Daily vegetable consumption assessed by a short dietary intake question, adapted from that used in Australia's National Nutrition Survey (1995), which was shown to discriminate between groups with different vegetable intakes assessed by 24-h recall
Timepoint [2] 320875 0
Baseline and week 12
Secondary outcome [1] 373188 0
Daily fruit consumption assessed by a short dietary intake question, adapted from that used in Australia's National Nutrition Survey (1995), which was shown to discriminate between groups with different fruit intakes assessed by 24-h recall
Timepoint [1] 373188 0
Baseline and week 38
Secondary outcome [2] 373189 0
Daily vegetable consumption assessed by a short dietary intake question, adapted from that used in Australia's National Nutrition Survey (1995), which was shown to discriminate between groups with different vegetable intakes assessed by 24-h recall
Timepoint [2] 373189 0
Baseline and week 38
Secondary outcome [3] 373190 0
Discretionary (non-core) food intake, assessed by self-report Food Frequency Questionnaire based on that used in the ShopSmart study (Ball et al., BMC Public Health 2013)
Timepoint [3] 373190 0
Baseline, week 12, week 38
Secondary outcome [4] 373191 0
Soft drink (full calorie) consumption, assessed by a single self-report item based on that used in the ShopSmart study (Ball et al., BMC Public Health 2013)
Timepoint [4] 373191 0
Baseline, week 12, week 38
Secondary outcome [5] 373192 0
Soft drink (low calorie) consumption, assessed by a single self-report item based on that used in the ShopSmart study (Ball et al., BMC Public Health 2013)
Timepoint [5] 373192 0
Baseline, week 12, week 38
Secondary outcome [6] 373193 0
Fruit juice consumption, assessed by a single self-report item, developed for this study based on similar questions used in the ShopSmart study (Ball et al., BMC Public Health 2013)
Timepoint [6] 373193 0
Baseline, week 12, week 38
Secondary outcome [7] 373194 0
Water consumption, assessed by a single self-report item based on that used in the ShopSmart study (Ball et al., BMC Public Health 2013)
Timepoint [7] 373194 0
Baseline, week 12, week 38
Secondary outcome [8] 373195 0
Milk type consumed, assessed by a single self-report item used in Australia's National Nutrition Survey
Timepoint [8] 373195 0
Baseline, week 12, week 38
Secondary outcome [9] 373196 0
Type of bread consumed, assessed by self-report, based on an item from the READI study (Ball et al,, IJE 2013)
Timepoint [9] 373196 0
Baseline, week 12, week 38
Secondary outcome [10] 373197 0
Starchy vegetables consumed, assessed by a single self-report item developed for this study
Timepoint [10] 373197 0
Baseline, week 12, week 38
Secondary outcome [11] 373198 0
Legumes consumed, assessed by a single self-report item developed for this study
Timepoint [11] 373198 0
Baseline, week 12, week 38
Secondary outcome [12] 373199 0
Self-efficacy for healthy eating, assessed by a self-report scale based on that used in the ShopSmart study (Ball et al., BMC Public Health 2013)
Timepoint [12] 373199 0
Baseline, week 12, week 38
Secondary outcome [13] 373200 0
Self-efficacy for food preparation/cooking, assessed by a self-report scale based on that used in the ShopSmart study (Ball et al., BMC Public Health 2013)
Timepoint [13] 373200 0
Baseline, week 12, week 38
Secondary outcome [14] 373201 0
Barriers to healthy eating, assessed by self-report survey items based on those used in the ShopSmart study (Ball et al., BMC Public Health 2013)
Timepoint [14] 373201 0
Baseline, week 12, week 38
Secondary outcome [15] 373359 0
Perceptions of the website, assessed by self-report (process evaluation) survey items developed for this study
Timepoint [15] 373359 0
Week 12 and 38
Secondary outcome [16] 373360 0
Perceptions of the SMS messages, assessed by self-report (process evaluation) survey items developed for this study
Timepoint [16] 373360 0
Week 12 and 38
Secondary outcome [17] 373361 0
Self-reported use of program materials (process evaluation), based on self-report survey items developed for this study
Timepoint [17] 373361 0
Week 12 and 38
Secondary outcome [18] 373362 0
Self-reported changes to food purchasing, cooking and eating (single question - process evaluation), based on a self-report item developed for this study
Timepoint [18] 373362 0
Week 12 and 38
Secondary outcome [19] 373363 0
Overall program perceptions, assessed by self-report survey items developed for this study
Timepoint [19] 373363 0
Week 12 and 38
Secondary outcome [20] 373695 0
Program engagement, assessed by website analytics: website log-ins, duration and pages engaged with. These markers were designed to assess engagement for this study
Timepoint [20] 373695 0
Assessed at weeks 12 and 38, retrospectively to cover program and follow-up duration
Secondary outcome [21] 373696 0
Program engagement, assessed by website analytics: text messages read/engaged with. This marker was designed to assess engagement for this study
Timepoint [21] 373696 0
Week 12

Eligibility
Key inclusion criteria
Adults aged 18 to 75 years with Type 2 diabetes. Participants will need to have, and use a mobile phone, be familiar with receiving and reading text messages, and have either mobile data allowance to access the Internet, or a mobile device (phone, tablet) or computer with internet access, or be willing to use a computer with internet access at a public or hospital library. Participants will be socioeconomically disadvantaged, as determined by being in receipt of either a health-care card or a pension as the main source of income
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they cannot speak or read English, cannot use mobile text messaging or access the internet, are pregnant, breastfeeding, or if they have an eating disorder or clinical depression (because diabetes management is typically more complex in these cases).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable - only one intervention group (no control)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable - not a randomised controlled trial
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
This is a feasibility (pre-post-follow-up) study. Intervention effects will be assessed by comparison of pre-(baseline), post-(12 weeks) and follow-up (38 weeks) intervention measures (repeated measures t-tests and Analyses of Variance) of dietary intake, dietary self-efficacy and barriers. Measures of program appeal and usability will be analysed using descriptive statistics (frequencies, ranges) for quantitative indicators, and thematic analysis for open-ended questions.

Our experience suggests that a sample of n=60 (conservatively assuming up to 33% drop-out) is sufficient for generating rich qualitative and contextual data on intervention engagement, feasibility and appeal, and estimates of effect that will help inform future larger studies. Our clinical co-investigators have confirmed that this number is feasible, with around 80 patients/week - mostly with Type 2 diabetes - attending clinics.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/08/2019
Actual
Date of last participant enrolment
Anticipated
6/11/2019
Actual
Date of last data collection
Anticipated
6/08/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14380 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 27381 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 303411 0
Charities/Societies/Foundations
Name [1] 303411 0
Diabetes Australia
Country [1] 303411 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Institute for Physical Activity and Nutrition Research
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 303460 0
None
Name [1] 303460 0
Address [1] 303460 0
Country [1] 303460 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303940 0
Western Health Low Risk Ethics Panel
Ethics committee address [1] 303940 0
Office for Research
3rd Floor, Western Centre for Health Research and Education
Sunshine Hospital
Furlong Rd. St Albans VIC 3021
Ethics committee country [1] 303940 0
Australia
Date submitted for ethics approval [1] 303940 0
22/01/2019
Approval date [1] 303940 0
02/04/2019
Ethics approval number [1] 303940 0
HREC/19/WH/49763

Summary
Brief summary
This project aims to test the appeal, feasibility and effects on eating behaviours of a scalable, evidence-based, web- and phone-delivered healthy eating program for socioeconomically disadvantaged adults with Type 2 diabetes. The project also aims to test the effects of the program on food-related skills and attitudes, including self-efficacy and perceived barriers to selecting and preparing a balanced healthy diet. Sixty adults with Type 2 diabetes, and who hold a health care card or pension (indicators of socioeconomic disadvantage), will be recruited, with 40 expected to complete the program and evaluations (conservatively assuming up to 33% drop-out). Participants will receive a 12-week, skills-based behaviour change program, aimed at increasing healthy eating skills, attitudes and behaviours. It is based on an evidence-based behaviour change program developed by the investigators, and delivered using 6 website modules and 36 SMS text messages. Effects on eating behaviours and attitudes will be assessed at baseline, immediately after the intervention (week 12), and six months (26 weeks) later (ie, at 12 and 38 weeks post-baseline). We will also assess participants' perceptions of the program (process evaluation) at weeks 12 and 38.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95326 0
Prof Kylie Ball
Address 95326 0
Institute for Physical Activity and Nutrition,
Deakin University
221 Burwood Hwy
Burwood VIC 3125
Country 95326 0
Australia
Phone 95326 0
+61 03 92517310
Fax 95326 0
Email 95326 0
[email protected]
Contact person for public queries
Name 95327 0
Dr Stella O'Connell
Address 95327 0
Institute for Physical Activity and Nutrition,
Deakin University
221 Burwood Hwy
Burwood VIC 3125
Country 95327 0
Australia
Phone 95327 0
+61 03 9244 6135
Fax 95327 0
Email 95327 0
[email protected]
Contact person for scientific queries
Name 95328 0
Prof Kylie Ball
Address 95328 0
Institute for Physical Activity and Nutrition,
Deakin University
221 Burwood Hwy
Burwood VIC 3125
Country 95328 0
Australia
Phone 95328 0
+61 03 92517310
Fax 95328 0
Email 95328 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants have not consented to having their data shared in this way. If researchers in future are interested in accessing the data, an ethically-compliant de-identified dataset will be made available upon receipt of appropriate ethical approvals.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3687Study protocol  [email protected]



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.