Condition category
Nutritional, Metabolic, Endocrine
Date applied
25/03/2008
Date assigned
16/05/2008
Last edited
30/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.som.uq.edu.au/research/cnrc/eatsmart.asp

Contact information

Type

Scientific

Primary contact

Dr Helen Truby

ORCID ID

Contact details

The Children's Nutrition Research Centre
Royal Children's Hospital
Herston
4029
Australia
+617 (0)3636 9271
h.truby@uq.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2008000262

Study information

Scientific title

A controlled trial of a reduced carbohydrate diet versus a low fat diet on weight, body composition and metabolic profile in obese adolescents

Acronym

Eat Smart

Study hypothesis

There will be no differences between a reduced carbohydrate diet and a low carbohydrate diet in markers of body composition after 6 months.

Ethics approval

1. Royal Children's hospital Human Ethics Committee, 08/01/2007, ref: 2006/096
2. University of Queensland Ethics Committee, 25/10/2006, ref: 2006000667
3. Mater Hospital Ethics Committee, 01/08/2007, ref: 1140C

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Childhood obesity

Intervention

1. Low fat diet (25% fat, 55% carbohydrate, 20% protein) for 24 weeks
2. Reduced carbohydrate diet (35% carbohydrate, 35% fat, 30% protein) for 24 weeks
3. Wait list control group. Those families allocated to the wait list control group will receive the full dietary program of their choice at the end of the control period (i.e. 12 weeks)

Both dietary programmes are structured with a lunch box and a standardised plate template system for dinner for portion size control. These are used across both intervention arms to ensure fidelity of intervention and increase compliance with dietary advice. Compliance is measured by diet diaries and activity diaries. Subjects are monitored weekly by phone and have 5 face-to-face sessions with study dietitian to assist with dietary adherence.

Duration of interventions: 24 weeks

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Change in body mass index standard deviation score (BMI Z score), assessed at baseline, 12 weeks (all three arms) and 24 weeks (only in active diet arms).

Secondary outcome measures

The following will be assessed at baseline, 12 weeks (all three arms) and 24 weeks (only in active diet arms):
1. Change in percentage body fat
2. Cardiometabolic markers of disease risk, including insulin level

Overall trial start date

02/02/2008

Overall trial end date

02/02/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 11- 17 years, both males and females
2. Body mass index >90th percentile for age
3. Parents/guardians are able to give informed written consent and child to give assent

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

135

Participant exclusion criteria

The following will be assessed at baseline, 12 weeks (all three arms) and 24 weeks (only in active diet arms):
1. Obesity with known medical cause
2. Taking stimulants, psychotropic medication, steroids or insulin senstisers

Recruitment start date

02/02/2008

Recruitment end date

02/02/2011

Locations

Countries of recruitment

Australia

Trial participating centre

Royal Children's Hospital
Herston
4029
Australia

Sponsor information

Organisation

National Heart Foundation (Australia)

Sponsor details

411 King Street
Melbourne 3003
Melbourne
3003
Australia
-
research@heartfoundation.com.au

Sponsor type

Charity

Website

http://www.heartfoundation.org.au

Funders

Funder type

Charity

Funder name

National Heart Foundation of Australia (ref: G 07B 3130)

Alternative name(s)

Heart Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Australia

Funder name

Royal Children's Hospital Foundation, Near Miss Fund (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20696032
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27022913

Publication citations

  1. Protocol

    Truby H, Baxter KA, Barrett P, Ware RS, Cardinal JC, Davies PS, Daniels LA, Batch JA, The Eat Smart Study: a randomised controlled trial of a reduced carbohydrate versus a low fat diet for weight loss in obese adolescents., BMC Public Health, 2010, 10, 464, doi: 10.1186/1471-2458-10-464.

  2. Results

    Truby H, Baxter K, Ware RS, Jensen DE, Cardinal JW, Warren JM, Daniels L, Davies PS, Barrett P, Blumfield ML, Batch JA, A Randomized Controlled Trial of Two Different Macronutrient Profiles on Weight, Body Composition and Metabolic Parameters in Obese Adolescents Seeking Weight Loss, PLoS One, 2016, 11, 3, e0151787, doi: 10.1371/journal.pone.0151787.

Additional files

Editorial Notes

30/03/2016: Publication reference added.