Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001170910
Ethics application status
Approved
Date submitted
4/11/2011
Date registered
9/11/2011
Date last updated
9/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Spend Study- A randomised controlled trial to examine the effect of providing additional money on food spending among low income households
Scientific title
A randomised controlled trial to examine the effect of providing additional money on food spending among food insecure, low income households
Secondary ID [1] 273338 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Household food expenditure as a proxy for food availability 279106 0
Condition category
Condition code
Public Health 279295 279295 0 0
Epidemiology
Diet and Nutrition 279298 279298 0 0
Obesity
Diet and Nutrition 279299 279299 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Weekly supermarket vouchers to the value of $5 (per adult female), received by the intervention group for four weeks. Vouchers allocated for the supermarket identified by each household as the most frequently used. Vouchers can be spent on any supermarket item.
Intervention code [1] 283680 0
Lifestyle
Comparator / control treatment
No vouchers
Control group
Active

Outcomes
Primary outcome [1] 279909 0
Expenditure on fruit and vegetables during the intervention phase. This was assessed using analysis of food shopping receipts and food purchase forms collected and completed during four weeks of baseline and four weeks of intervention. A linear regression model was used to compare the voucher and the control group for phase 2 expenditure, with baseline expenditure entered as a covariate.
Timepoint [1] 279909 0
Four weeks after intervention commencement
Secondary outcome [1] 294747 0
Intervention phase expenditure on total food. This was assessed using analysis of food shopping receipts and food purchase forms collected and completed during four weeks of baseline and four weeks of intervention. A linear regression model was used to compare the voucher and the control group for phase 2 expenditure, with baseline expenditure entered as a covariate.
Timepoint [1] 294747 0
Four weeks after intervention commencement
Secondary outcome [2] 294748 0
Intervention phase expenditure on dairy. This was assessed using analysis of food shopping receipts and food purchase forms collected and completed during four weeks of baseline and four weeks of intervention. A linear regression model was used to compare the voucher and the control group for phase 2 expenditure, with baseline expenditure entered as a covariate.
Timepoint [2] 294748 0
Four weeks after intervention commencement
Secondary outcome [3] 294749 0
Intervention phase expenditure on milk. This was assessed using analysis of food shopping receipts and food purchase forms collected and completed during four weeks of baseline and four weeks of intervention. A linear regression model was used to compare the voucher and the control group for phase 2 expenditure, with baseline expenditure entered as a covariate.
Timepoint [3] 294749 0
Four weeks after intervention commencement
Secondary outcome [4] 294750 0
Intervention phase expenditure on wholegrain bread, This was assessed using analysis of food shopping receipts and food purchase forms collected and completed during four weeks of baseline and four weeks of intervention. A linear regression model was used to compare the voucher and the control group for phase 2 expenditure, with baseline expenditure entered as a covariate.
Timepoint [4] 294750 0
Four weeks after intervention commencement
Secondary outcome [5] 294751 0
Intervention phase expenditure on meat and poultry. This was assessed using analysis of food shopping receipts and food purchase forms collected and completed during four weeks of baseline and four weeks of intervention. A linear regression model was used to compare the voucher and the control group for phase 2 expenditure, with baseline expenditure entered as a covariate.
Timepoint [5] 294751 0
Four weeks after intervention commencement

Eligibility
Key inclusion criteria
Trial inclusion criteria were: i) one child or more under 18 years living at home, ii) household gross annual income greater than 45,000 NZ dollars , iv) no expected change in household composition over the study period, e.g. long term guest, new baby, v) no expected change in household income over the study period, vi) purchasing at least two thirds of food from a supermarkets, vii) food insecure as determined by the validated NZ food security scale
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Food Secure
Income greater than 45,000 NZ dollars
No Children living within the household

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Households were allocated to the voucher or control group using block randomization. Households were randomized into either the voucher or the control group after they had been determined eligible, given informed consent and had begun their baseline phase. The allocation sequence was concealed from research assistants enrolling households. The allocation sequence was kept on a central computer, excel spreadsheet, which was password protected and assessible only to an investigator not involved in enrolling households.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization sequence was generated using Stata 10 (Stata Corp, College Station, Tex, USA) and block sizes (range 2-10) were randomly varied.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Households were not aware of the true study design. Households were told the study would have three parts (a, b & c). Parts a and b involved the collection of food shopping receipts only and during part c the household would receive extra food vouchers in addition to collecting food shopping receipts. They were informed they would receive notice and a study pack one week before the beginning of each part, which could start at a random time within the next 6 months. They were also told that the three parts would not necessarily run in a sequential order. In effect households believed the study to run for a longer time period than it actually did and were not sure when they would be receiving the food vouchers.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 3941 0
New Zealand
State/province [1] 3941 0
Otago

Funding & Sponsors
Funding source category [1] 284160 0
University
Name [1] 284160 0
University of Otago
Country [1] 284160 0
New Zealand
Primary sponsor type
Individual
Name
Claire Smith
Address
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 269118 0
Individual
Name [1] 269118 0
Associate Professor Winsome Parnell
Address [1] 269118 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin 9054
Country [1] 269118 0
New Zealand
Other collaborator category [1] 260335 0
Individual
Name [1] 260335 0
Dr Rachel Brown
Address [1] 260335 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin 9054
Country [1] 260335 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286123 0
University of Otago Human Ethics Committee
Ethics committee address [1] 286123 0
Ethics committee country [1] 286123 0
New Zealand
Date submitted for ethics approval [1] 286123 0
Approval date [1] 286123 0
Ethics approval number [1] 286123 0
1/09/0080

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

Contacts
Principal investigator
Name 33356 0
Address 33356 0
Country 33356 0
Phone 33356 0
Fax 33356 0
Email 33356 0
Contact person for public queries
Name 16603 0
Claire Smith
Address 16603 0
Unversity of Otago
Department of Human Nutrition
PO Box 56
Dunedin 9054
Country 16603 0
New Zealand
Phone 16603 0
+64 (03) 4795289
Fax 16603 0
Email 16603 0
[email protected]
Contact person for scientific queries
Name 7531 0
Claire Smith
Address 7531 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin 9054
Country 7531 0
New Zealand
Phone 7531 0
+64 (03) 4795289
Fax 7531 0
Email 7531 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
ThesisNo Smith C. Barriers and solutions to achieving food... [More Details]
Study results articleYes Smith C, Parnell WR, Brown RC, et al. Providing ad... [More Details]

Documents added automatically
No additional documents have been identified.