Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000151730
Ethics application status
Approved
Date submitted
21/12/2021
Date registered
28/01/2022
Date last updated
13/04/2024
Date data sharing statement initially provided
28/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A primary care-led weight management intervention for adults with type 2 diabetes and obesity: DiRECT to Aotearoa New Zealand
Scientific title
A primary care-led weight management intervention to consider efficacy and acceptability of the DiRECT study protocol in Aotearoa New Zealand: pilot randomised controlled trial of adults with type 2 diabetes and obesity.
Secondary ID [1] 306089 0
None
Universal Trial Number (UTN)
U1111-1268-6678
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes 324749 0
Obesity 324750 0
Condition category
Condition code
Diet and Nutrition 322200 322200 0 0
Obesity
Metabolic and Endocrine 322395 322395 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
DiRECT arm: The intervention arm will be usual care for those seeking to lose weight in New Zealand as well as a very low energy diet and weight loss maintenance phase delivered by a trained Dietitian at one medical centre (Te Kaika Health) in Caversham, Dunedin. Usual care includes weight loss advice, meal ideas, and lifestyle strategies delivered within the primary care service.

The protocol for this intervention is the DiRECT protocol applied in the UK. Briefly, the first three months is an active weight loss phase of total diet replacement. This is the consumption of 3-4 meal replacements per day providing approx. 3600 kJ/day using Cambridge Weight Plan products. These meal replacement products come in a range of sweet and savoury, and may be made up into shakes, soups, oats, and soups through the addition of water. This products are nutritionally complete and macronutrient balanced, but sufficiently low in energy to induce weight loss. These products are provided to participants of the intervention arm at no cost. To allow some flexibility for participants, the active weight loss phase may continue up to 20 weeks if they chose too. If during the active weight loss phase the participant Body Mass index (BMI) falls below 23 kg/m2, they commence the second phase, which is weight loss maintenance. For the active weight loss phase, participants will return for review after the first week, and then in two weekly intervals thereafter for the active weight loss period. These appointments are expected to be of 20 minutes duration and comprise of checking the participants health and mood, answering any questions, body weight and blood pressure measurements, and providing more meal replacement products for the week(s) ahead. These meetings are between the participant, and the dietitian coordinating the study.

Nine months of the weight loss maintenance phase commences once the participant leaves the active weight loss period. This second phase has a stepped food reintroduction period (flexible but up to two months duration) with supported for weight loss maintenance. During this reintroduction participants will move from 3-4 meal replacements each day to real food in health amounts along a time frame agreed upon by the participant and the Dietitian. During the stepped reintroduction of food participants will continue to see the Dietitian fortnightly. After food reintroduction, face to face meetings with the Dietitian are held monthly, although email and text or phone call support will continue when appropriate. These appointments are expected to be of 20 minutes duration and comprise of checking the participants health and mood, answering any questions, and taking body weight and blood pressure measurements. These meetings are between the participant, and the dietitian coordinating the study. During the nine months of supported weight loss, in the event of weight regain of 2-4kg, participants will be offered a 2-4 week period of partial meal replacement. This may be one or two meals each day from meal replacements and the remaining meals from food, depending on the goals and desires of the participant. In the event of weight regain over 4kg, participants will be offered a 2-4 week period of total diet replacement. The total intervention period of the study is 12 months. Adherence with the intervention will be assessed with 24 hour recalls (baseline, at three months, at 12 months) as will as session attendance checklists.
Intervention code [1] 322498 0
Lifestyle
Intervention code [2] 322640 0
Treatment: Other
Comparator / control treatment
Participants in the control arm will received usual care for those interested in losing weight, largely relating to lifestyle advice on physical activity, food intake, and motivation. Usual care for all trial participants will be delivered by the same services at Te Kaika Health seen by the intervention group. The same trial duration (12 months) and meeting schedule is applied for both intervention and control participants.
Control group
Active

Outcomes
Primary outcome [1] 329961 0
Glycated Haemoglobin (HbA1c) as measured from a fasting venous blood sample.
Timepoint [1] 329961 0
Baseline, post active intervention phase (at three months post intervention commencement), post weight loss maintenance phase (at twelve months post intervention commencement).
Primary outcome [2] 329962 0
Body weight (kg) measured by the research dietitian on a Tanita body weight scale.
Timepoint [2] 329962 0
Baseline, and 1, 2, 4, 6, 8, 10, 12 (primary endpoint), 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, and 52 weeks post-intervention commencement (every appointment for the study).
Primary outcome [3] 329963 0
Acceptability and feasibility of the weight loss programme (intervention or control) assessed through 30-minute, audio-recorded, semi-structured interviews using a study-specific questionnaire for both participants and the health care providers.
Timepoint [3] 329963 0
Three months post-intervention commencement (primary endpoint) and 12 months post-intervention commencement.
Secondary outcome [1] 404456 0
24hr blood glucose mean as measured by continuous glucose monitoring.
Timepoint [1] 404456 0
Baseline, post active intervention phase (at three months post-intervention commencement), post weight loss maintenance phase (at twelve months post-intervention commencement).
Secondary outcome [2] 404457 0
Fasting blood glucose taken as the mean blood glucose concentration between 4 and 6am from continuous blood glucose monitoring.
Timepoint [2] 404457 0
Baseline, post active intervention phase (at three months post-intervention commencement), post weight loss maintenance phase (at twelve months post-intervention commencement).
Secondary outcome [3] 404458 0
Night time blood glucose control taken as the mean blood glucose concentration between 8pm and 4am from continuous blood glucose monitoring.
Timepoint [3] 404458 0
Baseline, post active intervention phase (at three months post-intervention commencement), post weight loss maintenance phase (at twelve months post-intervention commencement).
Secondary outcome [4] 404459 0
Glycaemic variability as measured by the Mean Amplitude of glycaemic Excursion (MAGE) for each full 24-hour period captured from continuous blood glucose monitoring.
Timepoint [4] 404459 0
Baseline, post active intervention phase (at three months post-intervention commencement), post weight loss maintenance phase (at twelve months post-intervention commencement).
Secondary outcome [5] 404460 0
Glycaemic variability as measured by the standard deviation (SD) of the 24hr blood glucose average from continuous blood glucose monitoring.
Timepoint [5] 404460 0
Baseline, post active intervention phase (at three months post-intervention commencement), post weight loss maintenance phase (at twelve months post-intervention commencement).
Secondary outcome [6] 404461 0
Body Mass Index (BMI) from height measured at baseline by the Dietitian with a stadiometer and weight measured at that time point by the dietitian using a tanita body weight scale.
Timepoint [6] 404461 0
Baseline, and 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, and 52 weeks post-intervention commencement.
Secondary outcome [7] 404462 0
Body fat percentage as measured by bioelectrical impedance analysis scales.
Timepoint [7] 404462 0
Baseline, and 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, and 52 weeks post-intervention commencement.
Secondary outcome [8] 404463 0
Blood lipid analysis from fasted blood sample: Total cholesterol.
Timepoint [8] 404463 0
Baseline, post active intervention phase (at three months post-intervention commencement), post weight loss maintenance phase (at twelve months post-intervention commencement).
Secondary outcome [9] 404464 0
Blood lipid analysis from fasted blood sample: LDL cholesterol.
Timepoint [9] 404464 0
Baseline, post active intervention phase (at three months post-intervention commencement), post weight loss maintenance phase (at twelve months post-intervention commencement).
Secondary outcome [10] 404465 0
Blood lipid analysis from fasted blood sample: HDL cholesterol.
Timepoint [10] 404465 0
Baseline, post active intervention phase (at three months post-intervention commencement), post weight loss maintenance phase (at twelve months post-intervention commencement).
Secondary outcome [11] 404466 0
Blood lipid analysis from fasted blood sample: triglycerides.
Timepoint [11] 404466 0
Baseline, post active intervention phase (at three months post-intervention commencement), post weight loss maintenance phase (at twelve months post-intervention commencement).
Secondary outcome [12] 404467 0
C-reactive protein concentration from fasted blood sample.
Timepoint [12] 404467 0
Baseline, post active intervention phase (at three months post-intervention commencement), post weight loss maintenance phase (at twelve months post-intervention commencement).
Secondary outcome [13] 404468 0
Systolic and diastolic blood pressure taken as the average of three measures from an automated sphygmomanometer after being seated for five minutes.
Timepoint [13] 404468 0
Baseline, and 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, and 52 weeks post-intervention commencement.
Secondary outcome [14] 404469 0
Change in medication score using the defined daily dose (DDD).
Timepoint [14] 404469 0
Baseline, post active intervention phase (at three months post-intervention commencement), post weight loss maintenance phase (at twelve months post-intervention commencement).
Secondary outcome [15] 404470 0
Quality of life (measured with the Eq5d5l).
Timepoint [15] 404470 0
Baseline, post active intervention phase (at three months post-intervention commencement), post weight loss maintenance phase (at twelve months post-intervention commencement).

Eligibility
Key inclusion criteria
Participants will be diagnosed with type 2 diabetes, be aged 20-65, and have a BMI of 30 or over.
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Myocardial infarction in the last six months, heart failure, known cancer, diagnosed eating disorder, current treatment with anti-obesity drugs, current insulin use, and pregnancy.

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)
central randomisation by computer (built into REDCap online portal).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computerised sequence generation, no stratification.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study to consider the acceptability of a recognised weight loss protocol in Aotearoa New Zealand. As such, no power calculation has been undertaken for the efficacy outcomes although the data collected will support funding for and the sample size estimate of a fully powered study. The sample size is sufficient to capture a range of perspectives on the acceptability of this weight loss protocol in Aotearoa New Zealand with qualitative interviews at three and 12 months post baseline.

Analyses of quantitative data will follow what was laid out in the protocol paper
and results paper of the initial DiRECT studies undertaken in the UK: The planned primary analyses done according to the intention-to-treat principle. The co-primary outcomes will be analysed in a hierarchical manner, the weight loss outcome first, with no adjustment of the p values for multiple comparisons. For the main analysis of secondary outcomes, no assumptions will be made regarding missing data. Outcomes will be compared between groups with mixed-effects regression models. The analysis of the DiRECT protocol we are following is published here: Lean et al. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet 2018; 391: 541–51

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2022
Actual
17/03/2022
Date of last participant enrolment
Anticipated
31/03/2022
Actual
22/12/2022
Date of last data collection
Anticipated
17/01/2024
Actual
20/12/2023
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 24457 0
New Zealand
State/province [1] 24457 0
Otago

Funding & Sponsors
Funding source category [1] 310431 0
Government body
Name [1] 310431 0
Ministry of Social Development
Country [1] 310431 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
Otakou Health Limited
Address
25 College Street
Caversham Dunedin 9012
New Zealand.
Country
New Zealand
Secondary sponsor category [1] 311590 0
None
Name [1] 311590 0
None
Address [1] 311590 0
None
Country [1] 311590 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310068 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 310068 0
Ethics committee country [1] 310068 0
New Zealand
Date submitted for ethics approval [1] 310068 0
18/11/2021
Approval date [1] 310068 0
08/03/2022
Ethics approval number [1] 310068 0
2022 EXP 11570

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116382 0
Dr Kim Ma'ia'i
Address 116382 0
Te Kaika Health
25 College Street
Caversham Dunedin Otago 9012
New Zealand
Country 116382 0
New Zealand
Phone 116382 0
+6421451923
Fax 116382 0
Email 116382 0
[email protected]
Contact person for public queries
Name 116383 0
Andrew Reynolds
Address 116383 0
Department of Medicine
PO Box 56
Dunedin Otago 9012
New Zealand
Country 116383 0
New Zealand
Phone 116383 0
+64279565826
Fax 116383 0
Email 116383 0
[email protected]
Contact person for scientific queries
Name 116384 0
Andrew Reynolds
Address 116384 0
Department of Medicine
PO Box 56
Dunedin Otago 9012
New Zealand
Country 116384 0
New Zealand
Phone 116384 0
+64279565826
Fax 116384 0
Email 116384 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
We are not seeking consent from participants to share their data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14497Study protocol  [email protected]
14498Statistical analysis plan  [email protected]
14499Informed consent form  [email protected]
14500Ethical approval  [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.