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
ACTRN12616001193460
Ethics application status
Approved
Date submitted
26/08/2016
Date registered
30/08/2016
Date last updated
30/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
In healthy adults, is provision of nutritional support effective for following a low dietary free sugars intake?
Scientific title
A mixed-methods exploratory study examining the effect of nutritional support and dietary support aids for healthy adults following a diet low in free sugars (aiming for <5% energy intake/day) on barriers and facilitators to compliance and dietary changes.
Secondary ID [1] 290028 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dietary intake 300059 0
Obesity 300060 0
Cardiovascular Disease 300061 0
Condition category
Condition code
Diet and Nutrition 299945 299945 0 0
Obesity
Public Health 299948 299948 0 0
Health promotion/education
Cardiovascular 299979 299979 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive verbal and written nutrition education from a student dietitian focusing on how to select and prepare foods and beverages low in free sugars. This includes a booklet created by the student dietitian which includes information on label reading for free sugars, food exchanges which are low in free sugars, artificial sweeteners and recipes low in free sugars. Participants will attend weekly one-on-one consultation clinics (for approximately 30 minutes) for four weeks. Dietary free sugars intake will be measured at baseline using a food frequency questionnaire and 3-day weighed diet record. Participants will then attempt to undertake a diet low in free sugars for four weeks (target <5% total energy intake/day) from the second weekly consultation visit (once baseline measures have been taken), consuming foods and beverages of their own choice. Participants will then receive tailored nutrition advice and support from a student dietitian for maintaining a diet low in free sugars.

Over the period there will be a log of attendance. At four weeks, participants will complete the same food frequency questionnaire and another 3-day weighed diet record to assess nutrient intakes and monitor adherence to the intervention. In addition, participants will attend a semi-structured interview at the end of the low free sugars diet period to evaluate effectiveness of the dietary support aids.
Intervention code [1] 295744 0
Prevention
Intervention code [2] 295745 0
Behaviour
Intervention code [3] 295746 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299435 0
Composite outcome evaluating effectiveness of dietary resources developed by student dietitian and facilitators/barriers towards following a diet low in free sugars assessed through semi-structured interviews with the participants
Timepoint [1] 299435 0
At the end of the four-week low free sugars diet period
Primary outcome [2] 299436 0
Dietary free sugars intake associated with following a diet low in free sugars as assessed by a food frequency questionnaire (developed specifically for this study) and 3-day weighed diet records
Timepoint [2] 299436 0
At baseline and at the end of the four-week low free sugars diet period
Secondary outcome [1] 327140 0
Changes in the intakes of energy, sodium, potassium, total fat and saturated fat (nutrients associated with cardiovascular risk) will be assessed through 3-day weighed diet records
Timepoint [1] 327140 0
At baseline and at the end of the four-week low free sugars diet period

Eligibility
Key inclusion criteria
Healthy males and females aged 18-65 years who will be residing in Dunedin for the duration of the study
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those who are currently already restricting their intake of dietary sugars or who have an estimated free sugars intake <5% total energy intake/day

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/08/2016
Date of last participant enrolment
Anticipated
5/09/2016
Actual
Date of last data collection
Anticipated
3/10/2016
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 8126 0
New Zealand
State/province [1] 8126 0
Otago

Funding & Sponsors
Funding source category [1] 294395 0
University
Name [1] 294395 0
University of Otago
Country [1] 294395 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Human Nutrition
PO Box 56
University of Otago
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 293243 0
None
Name [1] 293243 0
Address [1] 293243 0
Country [1] 293243 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295817 0
University of Otago Human Ethics Committee
Ethics committee address [1] 295817 0
University of Otago
P.O. Box 56
Dunedin 9054
New Zealand
Ethics committee country [1] 295817 0
New Zealand
Date submitted for ethics approval [1] 295817 0
22/07/2016
Approval date [1] 295817 0
05/08/2016
Ethics approval number [1] 295817 0

Summary
Brief summary
This is a mixed-methods exploratory research project exploring the barriers and facilitators faced by individuals attempting to reduce their free sugars intake in line with World Health Organisation recommendations and within the current food environment.

There is growing concern that high intakes of free sugars increases energy intake and may reduce the intake of more nutritious foods leading to an unhealthy diet and weight gain. Also of concern, is the association between free sugars intake and tooth decay. To prevent and control unhealthy weight gain and tooth decay, the World Health Organisation recommends that the intake of free sugars be <5% of total energy intake/day. For an average adult, this is approximately 5 teaspoons of sugar per day. Free sugars are defined as sugars added to foods and drinks by the consumer, cook or manufacturer as a sweetener and includes honey, fruit juices, syrups and purees. Previous studies have indicated it may be difficult for people to adhere to the World Health Organisation free sugars recommendation, and facilitators and barriers to adherence are unknown. It is also unknown whether adhering to a diet low in free sugars is associated with other dietary changes that can affect health (it is likely that such changes will be beneficial to health but this has not been tested). Therefore, more research is needed to investigate the effectiveness of dietary support aids, and to explore whether diets low in free sugars are associated with other dietary changes that may influence cardiovascular disease risk markers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68586 0
Dr Lisa Te Morenga
Address 68586 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 68586 0
New Zealand
Phone 68586 0
+ 64 3 479 3978
Fax 68586 0
Email 68586 0
[email protected]
Contact person for public queries
Name 68587 0
Dr Lisa Te Morenga
Address 68587 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 68587 0
New Zealand
Phone 68587 0
+ 64 3 479 3978
Fax 68587 0
Email 68587 0
[email protected]
Contact person for scientific queries
Name 68588 0
Dr Lisa Te Morenga
Address 68588 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 68588 0
New Zealand
Phone 68588 0
+ 64 3 479 3978
Fax 68588 0
Email 68588 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.