Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001640493
Ethics application status
Approved
Date submitted
1/12/2014
Date registered
28/11/2016
Date last updated
28/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
To evaluate the acceptability, adherence, affordability and efficacy of carbohydrate-restricted diets in the treatment of obesity in children.
Scientific title
To evaluate the acceptability, adherence, affordability and efficacy of carbohydrate-restricted diets in the treatment of obesity in children aged 8-13 years.
Secondary ID [1] 285764 0
Nil
Universal Trial Number (UTN)
U111111584409
Trial acronym
Low Carb Kids
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 293648 0
Condition category
Condition code
Diet and Nutrition 293945 293945 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The feasibility study (n=25) was a single-arm, 12-week dietary intervention addressing short-term weight loss, health outcomes and and feasibility aspects. Children aged 8-13years consumed a diet based on whole food that aligns with a low carbohydrate, high fat (LCHF) philosophy.

Once assessed for eligibility and their place confirmed on the trial, participants and their parents attended a 90 minute face-to-face workshop delivered by a Registered Dietitian and Endocrinologist (both part of the research team) detailing the dietary approach. Four of these session were conducted as recruitment took place. Participants and their families had the opportunity to answer questions during this time. They were also provided with supporting resources. which consisted of a designated website the team created specifically for this research project.

Participants were not prescribed with a personalised set of energy and macronutrient requirements, but rather they were provided with general guidelines about concepts and foods to consume and to avoid on their respective diet. It was anticipated that the LCHF style of eating reflected a carbohydrate intake approximating less than the lower range of mainstream dietary recommendation i.e., <45% of total energy; a higher fat intake, approximating more than 33% of total energy, and a moderate protein intake, approximating 15-25% of total energy.

Before each participant started, they attended the dietitian's clinic, where they had their weight, height and waist circumference measured. Immediately following that, they received a kit which they were to take to the hospital for their blood test, which was fasting. All anthropometric measures were conducted at the dietitian's clinic and all blood tests were conducted at Hawkes Bay Hospital. A full set of outcomes (i.e. weight, height, waist circumference and a venepuncture serum assay to assess lipids and glycaemic control were measured at weeks 0 (prior to the start of the intervention) and at week 12. At weeks 4 and 8, a weight, height and waist measure were recorded at their dietary consultation with the dietitian for monitoring and support purposes.

Parents were called on the telephone each week during the 12 week intervention and asked about their child's progress. Adherence was measured during these weekly phonecalls where parents were asked what the children were eating and how well they were adhering to the protocol. Adherence was also measured each four weeks, during the consultation with the dietitian as well as in a focus group at the end of the intervention.
Intervention code [1] 290725 0
Lifestyle
Intervention code [2] 296494 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293721 0
Adherence
Timepoint [1] 293721 0
Qualitatively: Weekly via telephone and face-to-face meetings, in a focus group after week 12. A general conversation about types of foods eaten and a 24-hour recall will be conducted over the phone and in person.
Primary outcome [2] 300296 0
Diet acceptability
Timepoint [2] 300296 0
Qualitatively: Weekly via telephone and face-to-face meetings, in a focus group after week 12. A general conversation about types of foods liked and disliked will be conducted over the phone and in person.
Primary outcome [3] 300297 0
Affordability
Timepoint [3] 300297 0
Qualitatively: Weekly via telephone and face-to-face meetings, in a focus group after week 12. A general conversation about types of foods liked and disliked will be conducted over the phone and in person.
Secondary outcome [1] 311661 0
BMI
Timepoint [1] 311661 0
BMI will be calculated at time 0, 4, 8 and 12 weeks using a measure of weight and height.
Secondary outcome [2] 329644 0
Waist circumference
Timepoint [2] 329644 0
Waist circumference will be measured at time 0, 4, 8 and 12 weeks.
Secondary outcome [3] 329645 0
Lipid profile
Timepoint [3] 329645 0
Weeks 0 and 12 weeks using venepuncture serum assay.
Secondary outcome [4] 329646 0
Glycaemic control
Timepoint [4] 329646 0
Weeks 0 and 12 weeks using venepuncture serum assay.
Secondary outcome [5] 329647 0
Attrition
Timepoint [5] 329647 0
This will be measured at 12 weeks.

Eligibility
Key inclusion criteria
8-13 year old children (free from diagnosed medical illness), with a BMI greater than the 90th percentile for age and gender according to the growth charts of the Centers for Disease Control and Prevention.
Minimum age
8 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Free from diagnosed medical illness

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)
Enrollment / recruitment will be conducted via General Practitioners' targeting relevant children on their databases. This is a single arm trial therefore allocation criteria do not apply.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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
As this is a single-armed feasibility study, 25 participants was deemed sufficient to address all feasibility issues and is achievable given the available time and resources for the feasibility study. The estimated sample size for the full trial (RCT proposed after this one) is a key aspect to be addressed in the feasibility study, using change in percentage body fat as the primary outcome.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/10/2014
Date of last participant enrolment
Anticipated
Actual
10/03/2015
Date of last data collection
Anticipated
Actual
31/07/2015
Sample size
Target
25
Accrual to date
Final
25
Recruitment outside Australia
Country [1] 6502 0
New Zealand
State/province [1] 6502 0

Funding & Sponsors
Funding source category [1] 290331 0
Government body
Name [1] 290331 0
Health Research Council
Country [1] 290331 0
New Zealand
Primary sponsor type
University
Name
AUT University
Address
AUT University. Akoranga Campus Private Bag 92006, Northcote, 1020, Auckland
Country
New Zealand
Secondary sponsor category [1] 289049 0
Hospital
Name [1] 289049 0
Hawkes Bay DHB
Address [1] 289049 0
Hawke’s Bay District Health Board
Private Bag 9014
Hastings 4156
Country [1] 289049 0
New Zealand
Other collaborator category [1] 278255 0
Hospital
Name [1] 278255 0
Auckland Hospital
Address [1] 278255 0
Auckland Hospital. Private Bag 92024, Auckland Mail Centre, Auckland 1142
Country [1] 278255 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292037 0
Health and Disability Ethics Committees
Ethics committee address [1] 292037 0
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street. PO Box 5013, Wellington, 6011
Ethics committee country [1] 292037 0
New Zealand
Date submitted for ethics approval [1] 292037 0
Approval date [1] 292037 0
16/07/2014
Ethics approval number [1] 292037 0
14/NTA/99

Summary
Brief summary
Current “best practice” weight loss guidelines promote an energy-restricted, high carbohydrate, low fat macronutrient profile. This has had limited efficacy, and highly suggests alternative strategies are needed to improve adherence to good dietary practices and sustained health outcomes, especially in children. We propose a single-arm feasibility trial to first assess the acceptability, adherence, perceived affordability and rate of attrition for this alternative diet regime, and the magnitude of change in body composition, in particular percentage body fat, and metabolic parameters (blood lipids, endocrine and inflammatory markers). Subject to successful outcomes, a RCT is planned.
Trial website
Trial related presentations / publications
Zinn, C., Williden, M., McPhee, J., Wheldon, M., Harris, N., Schmiedel, O., Stride, D, & Schofield, G. Low Carb kids – a whole-food, weight loss feasibility study. Poster presentation at The Ancestral Health Symposium, Boulder, Colorado, August, 2016.
Public notes

Contacts
Principal investigator
Name 53166 0
Dr Caryn Zinn
Address 53166 0
AUT University. School of Sport & recreation. Private Bag 92006, Northcote, 1020.
Country 53166 0
New Zealand
Phone 53166 0
+64 9 921 9999 ext 7842
Fax 53166 0
Email 53166 0
[email protected]
Contact person for public queries
Name 53167 0
Caryn ZInn
Address 53167 0
AUT University. School of Sport & recreation. Private Bag 92006, Northcote, 1020.
Country 53167 0
New Zealand
Phone 53167 0
+64 9 921 9999 ext 7842
Fax 53167 0
Email 53167 0
[email protected]
Contact person for scientific queries
Name 53168 0
Grant Schofield
Address 53168 0
AUT University. AUT Millennium, 17 Antares Place, Mairangi Bay, Auckland. 0632
Country 53168 0
New Zealand
Phone 53168 0
+64 9 921 9999
Fax 53168 0
Email 53168 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



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