ANZCTR - Registration

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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]

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

Condition category

Condition code

Metabolic and Endocrine

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Baseline, and then at 3, 6, 9 and 12 months.

Secondary outcome [1]

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]

Baseline only.

Secondary outcome [2]

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]

Height will be collected at baseline only. All other factors will also be collected at 3, 6, 9 and 12 months.

Secondary outcome [3]

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]

The K10 questionnaire will be administered at baseline, 6 and 12 months only.

Secondary outcome [4]

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]

Baseline, 3, 6, 9 and 12 months.

Secondary outcome [5]

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]

9-months only.

Secondary outcome [6]

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]

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?

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]

University

Name [1]

Menzies Health Institute of Queensland, Griffith University.

Address [1]

58 Parklands Dr, Southport QLD 4215

Country [1]

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]

Individual

Name [1]

Dr Lauren Ball

Address [1]

Griffith University (Gold Coast Campus). 58 Parklands Dr, Southport QLD 4215

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Professor Lauren T Williams

Address [2]

Griffith University (Gold Coast Campus). 58 Parklands Dr, Southport QLD 4215

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Office for Research, Griffith University

Ethics committee address [1]

170 Kessels Rd, Nathan QLD 4111

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/10/2017

Approval date [1]

05/02/2018

Ethics approval number [1]

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

Dr Lauren Ball

Address

Griffith University (Gold Coast Campus). 58 Parklands Dr, Southport QLD 4215

Country

Australia

Phone

+61 413 031 470

Fax

l.ball@griffith.edu.au

Contact person for public queries

Name

Lauren Ball

Address

Griffith University (Gold Coast Campus). 58 Parklands Dr, Southport QLD 4215

Country

Australia

Phone

+61 413 031 470

Fax

l.ball@griffith.edu.au

Contact person for scientific queries

Name

Lauren Ball

Address

Griffith University (Gold Coast Campus). 58 Parklands Dr, Southport QLD 4215

Country

Australia

Phone

+61 413 031 470

Fax

l.ball@griffith.edu.au

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1606	Study protocol				https://www.mdpi.com/2072-6643/11/1/158

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	How does diet change with a diagnosis of diabetes? Protocol of the 3d longitudinal study.	2019	https://dx.doi.org/10.3390/nu11010158
Embase	Short-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.	2020	https://dx.doi.org/10.1038/s41387-020-0128-3
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.	2021	https://dx.doi.org/10.1093/fampra/cmz081
Embase	What happens to diet quality in people newly diagnosed with type 2 diabetes? The 3D case-series study.	2022	https://dx.doi.org/10.1111/jhn.12953

N.B. These documents automatically identified may not have been verified by the study sponsor.

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