Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000375257
Ethics application status
Approved
Date submitted
5/03/2018
Date registered
13/03/2018
Date last updated
13/03/2019
Date data sharing statement initially provided
13/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
How does Diet change with a Diagnosis of Diabetes? The 3D Longitudinal Study.
Scientific title
The 3D Longitudinal Study: an observational study of diet quality change in people newly diagnosed with type 2 diabetes.
Secondary ID [1] 293189 0
Nil known
Universal Trial Number (UTN)
U1111-1206-4907
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes mellitus 305187 0
Condition category
Condition code
Metabolic and Endocrine 304503 304503 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
An observational approach will provide a quantitative understanding of diet quality changes in individuals newly diagnosed with T2DM over a 12-month period. Demographic, physical and psychosocial factors will also be examined to determine those that are predictive of sustained improvements in diet quality. All data will be collected using interviewer-administered telephone survey at five time points across the 12-month period; baseline, and then at 3, 6, 9, and 12 months. Interviews will last approximately 30 minutes each.
Intervention code [1] 299443 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303743 0
Diet quality change as measured by the Dietary Approaches to Stop Hypertension (DASH) diet score. Dietary intake data will be obtained during the interviewer-administered telephone survey using the Australian version of the Automated Self-Administered 24 hour (ASA-24) dietary recall tool. The interviewer will enter in the data on behalf of the participant. Each participant’s DASH score will be calculated at each data collection point using the DASH diet-quality tool. The tool determines a score between 8 and 40 points, with 40 points representing optimal accordance with the DASH dietary pattern.
Timepoint [1] 303743 0
Baseline, and then at 3, 6, 9 and 12 months.
Secondary outcome [1] 340031 0
Demographic factors: age, gender, highest education level, living arrangement, self-selected social class, household income, manageability of income and smoking status. This information will be collected using a purposely developed interviewer-administered telephone survey. The questions and response options were composed to align with the Australian Bureau of Statistics (ABS) 2016 Census and The Australian Longitudinal Study on Women's Health (ALSWH) to allow for comparison of outcomes.
Timepoint [1] 340031 0
Baseline only.
Secondary outcome [2] 343920 0
Self-reported physical factors: waist circumference, weight, height and BMI. This information will be collected using a purposely developed interviewer-administered telephone survey. The questions and response options were composed to align with the Australian Bureau of Statistics (ABS) 2016 Census and The Australian Longitudinal Study on Women's Health (ALSWH) to allow for comparison of outcomes. Physical activity levels will also be assessed using the validated International Physical Activity Questionnaire (short form).
Timepoint [2] 343920 0
Height will be collected at baseline only. All other factors will also be collected at 3, 6, 9 and 12 months.
Secondary outcome [3] 343921 0
Anxiety and depressive symptoms will be assessed using the validated Kessler Psychological Distress Scale (K10). This is a 10-item questionnaire intended to yield a global measure of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period.
Timepoint [3] 343921 0
The K10 questionnaire will be administered at baseline, 6 and 12 months only.
Secondary outcome [4] 368188 0
Medication use: Information on all medication use (name of medication and dosage) will be collected, including over-the-counter, and complementary medicines. This outcome will be assessed using a study-specific questionnaire.
Timepoint [4] 368188 0
Baseline, 3, 6, 9 and 12 months.
Secondary outcome [5] 368189 0
Glycemic control (composite secondary outcome): HbA1c and fasting blood glucose results over the 12-month study period will be collected. Participants will send copies of their results to the research team.
Timepoint [5] 368189 0
9-months only.
Secondary outcome [6] 368190 0
Pathology results (composite secondary outcome): Other blood results collected will include; high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and C-reactive protein. Participants will send copies of their results to the research team.
Timepoint [6] 368190 0
9 months

Eligibility
Key inclusion criteria
Diagnosed with T2DM <6 months prior to recruitment contact.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals aged <18 years.
Diagnosed with T1DM, gestational diabetes or pre-diabetes.
Individuals who have been placed on a special diet due to a co-morbidity (eg. Renal disease).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A Bayesian approach will be employed for all statistical analyses. Changes in Dietary Approaches to Stop Hypertension (DASH) score between baseline and 3 months will be calculated for each participant. Participants will be split into 2 groups; those who improved their DASH score by at least 3 DASH points (Group 1) and those who maintained their DASH score within 2.99 points or decreased their DASH score by at least 3 points (Group 2). Descriptive statistics and frequency distribution will be presented for all DASH-scores, which will meet the first aim of the study. A mixed effect model will be used to examine DASH score at 12 months and asses the predictors of change (demographic, physical and psychosocial) according to change group at 3 months. The statistical program “R” will be used to conduct all analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/03/2018
Actual
1/05/2018
Date of last participant enrolment
Anticipated
1/01/2020
Actual
Date of last data collection
Anticipated
1/01/2021
Actual
Sample size
Target
300
Accrual to date
225
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 297819 0
University
Name [1] 297819 0
Menzies Health Institute of Queensland, Griffith University.
Country [1] 297819 0
Australia
Primary sponsor type
Individual
Name
Emily Burch
Address
Griffith University (Gold Coast Campus).
58 Parklands Dr, Southport QLD 4215.
Country
Australia
Secondary sponsor category [1] 296860 0
Individual
Name [1] 296860 0
Dr Lauren Ball
Address [1] 296860 0
Griffith University (Gold Coast Campus). 58 Parklands Dr, Southport QLD 4215
Country [1] 296860 0
Australia
Secondary sponsor category [2] 297310 0
Individual
Name [2] 297310 0
Professor Lauren T Williams
Address [2] 297310 0
Griffith University (Gold Coast Campus). 58 Parklands Dr, Southport QLD 4215
Country [2] 297310 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298873 0
Office for Research, Griffith University
Ethics committee address [1] 298873 0
170 Kessels Rd, Nathan QLD 4111
Ethics committee country [1] 298873 0
Australia
Date submitted for ethics approval [1] 298873 0
17/10/2017
Approval date [1] 298873 0
05/02/2018
Ethics approval number [1] 298873 0
2017/951

Summary
Brief summary
Healthy eating can assist people with Type 2 Diabetes Mellitus (T2DM) to achieve and maintain glycaemic control, thereby lowering their risk of developing diabetes-related complications. A dietary pattern rich in whole-grains, fruits, vegetables, legumes, and nuts; moderate in alcohol; and low in refined grains, red or processed meats, and sugar-sweetened beverages has been shown to improve glycaemic control in people with T2DM. Consequently, a key feature of international T2DM management recommendations is to eat healthy foods that provide a high-quality diet.

People with T2DM have been identified to have low-quality diets, despite recommendations to eat healthy foods. However, it is currently unclear whether people newly diagnosed with T2DM change their diet quality after diagnosis, nor if they maintain positive changes over time. No research has quantitatively explored changes in diet quality after diagnosis, and the factors (demographic, physical and psychosocial) that predict sustained improvements. Therefore, there is no evidence as to whether diet quality remains fixed once an individual is diagnosed with T2DM, or whether there are periods of marked dietary change. There is a clear need to investigate how diet changes over time so targeted strategies can be developed to facilitate improved glycaemic control. Therefore, the aims of the proposed study are to;

(i) Describe diet quality changes in the 12 months following T2DM diagnosis.
(ii) Identify the demographic, physical and psychosocial predictors of sustained improvements in diet quality defined as an increase in Dietary Approaches to Stop Hypertension (DASH) score of 3 points.
Trial website
https://drlaurenball.com/the-3d-study/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78514 0
Dr Lauren Ball
Address 78514 0
Griffith University (Gold Coast Campus). 58 Parklands Dr, Southport QLD 4215
Country 78514 0
Australia
Phone 78514 0
+61 413 031 470
Fax 78514 0
Email 78514 0
[email protected]
Contact person for public queries
Name 78515 0
Dr Lauren Ball
Address 78515 0
Griffith University (Gold Coast Campus). 58 Parklands Dr, Southport QLD 4215
Country 78515 0
Australia
Phone 78515 0
+61 413 031 470
Fax 78515 0
Email 78515 0
[email protected]
Contact person for scientific queries
Name 78516 0
Dr Lauren Ball
Address 78516 0
Griffith University (Gold Coast Campus). 58 Parklands Dr, Southport QLD 4215
Country 78516 0
Australia
Phone 78516 0
+61 413 031 470
Fax 78516 0
Email 78516 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date determined.
Available to whom?
Available to researchers from all disciplines on a case-by-case basis at the discretion of principal investigators.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access subject to approvals by principle investigators, requirement to sign data access agreement, etc.


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1606Study protocol    https://www.mdpi.com/2072-6643/11/1/158


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1606[Marked for deletion] [Marked for deletion][Marked for deletion][Marked for deletion][Marked for deletion] [Marked for deletion] [Marked for deletion]

Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHow does diet change with a diagnosis of diabetes? Protocol of the 3d longitudinal study.2019https://dx.doi.org/10.3390/nu11010158
EmbaseWhat happens to diet quality in people newly diagnosed with type 2 diabetes? The 3D case-series study.2022https://dx.doi.org/10.1111/jhn.12953
Embase'I could have made those changes years earlier': Experiences and characteristics associated with receiving a prediabetes diagnosis among individuals recently diagnosed with type 2 diabetes.2021https://dx.doi.org/10.1093/fampra/cmz081
EmbaseShort-term improvements in diet quality in people newly diagnosed with type 2 diabetes are associated with smoking status, physical activity and body mass index: the 3D case series study.2020https://dx.doi.org/10.1038/s41387-020-0128-3
N.B. These documents automatically identified may not have been verified by the study sponsor.