NCT02373423

Brief Summary

A clustered-randomized controlled trial in which 45 food companies are the unit of randomization. The intervention companies will receive an advocacy program which comprises of commonly used advocacy actions, incorporating a theory of change model. The control companies will have no specific intervention targeted at them. The aim of this study is to quantify the effects of advocacy delivered by a local non-government organization on the salt content of food products produced or marketed by companies in Australia.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

2.5 years

First QC Date

February 8, 2015

Last Update Submit

May 2, 2017

Conditions

Reducing Salt in the Food Supply

Outcome Measures

Primary Outcomes (1)

  • Mean sodium content change as measured by sodium content (mg) per 100g of food product

    Mean sodium content change as measured by sodium content (mg) per 100g of food

    Two years

Secondary Outcomes (6)

  • The number of and type of publicly available statements from food companies expressing support / non-support for healthier processed foods as measured by a count of statements.

    18 months

  • The number of food companies with a nutrition policy published on their website, as measured by a count

    18 months

  • The level of engagement with the non-government organization, as measured by a count of pre-defined methods of communication from the food company

    18 months

  • The number of companies supporting the use of salt replacers / technologies in food processing to reduce the quantity of sodium required in processing, as measured by a questionnaire

    18 months

  • The number of companies supporting national salt reduction initiatives as measured by a count of public pledges

    18 months

  • +1 more secondary outcomes

Other Outcomes (3)

  • Exploratory outcome: change in average saturated fat as measured by grams per 100g of product

    2 years

  • Exploratory outcome: change in average sugars content as measured by grams of sugar per 100g of product

    2 years

  • Exploratory outcome: change in average energy density content as measured by kilojoules (kJ) per 100g of product

    2 years

Study Arms (2)

Advocacy program

EXPERIMENTAL

A series of commonly used advocacy actions which will incorporate a theory of change model. Each advocacy action is targeted to change organizational capability, opportunity, or motivation of food companies to reduce salt in processed packaged foods. The intervention will span 24 months from 2013-2015.

Other: Advocacy

Control

NO INTERVENTION

No intervention program

Interventions

AdvocacyOTHER

See above for description

Advocacy program

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The unit of randomization is a food company. Food companies were included if they had
  • Australian based production, distribution or marketing of processed foods.
  • or more processed food items recorded in a food composition database (2011).
  • the types of food they manufacturer are likely to contain added salt, sugars or saturated fats.

You may not qualify if:

  • No identifiable Australian operation.
  • Less than 20 processed food items recorded in a food composition database (2011).
  • A company was known to be in receivership.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Trevena H, Thow AM, Dunford E, Wu JHY, Neal B. Protocol for a cluster-randomised trial to determine the effects of advocacy actions on the salt content of processed foods. BMC Public Health. 2016 Jan 25;16:75. doi: 10.1186/s12889-016-2743-4.

    PMID: 26809561DERIVED

Study Officials

  • Bruce Neal, PhD

    The George Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2015

First Posted

February 27, 2015

Study Start

December 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 4, 2017

Record last verified: 2017-05