A randomised controlled trial of a reduced carbohydrate diet versus a low fat diet for the treatment of childhood obesity: the Eat Smart Study
| ISRCTN | ISRCTN49438757 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49438757 |
| Protocol serial number | 2008000262 |
| Sponsor | National Heart Foundation (Australia) |
| Funders | National Heart Foundation of Australia (ref: G 07B 3130), Royal Children's Hospital Foundation, Near Miss Fund (Australia) |
- Submission date
- 25/03/2008
- Registration date
- 16/05/2008
- Last edited
- 30/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Helen Truby
Scientific
Scientific
The Children's Nutrition Research Centre
Royal Children's Hospital
Herston
4029
Australia
| Phone | +617 (0)3636 9271 |
|---|---|
| h.truby@uq.edu.au |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | Eat Smart |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) | 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). |
| Key secondary outcome measure(s) | 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 |
| Completion date | 02/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 135 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 02/02/2008 |
| Date of final enrolment | 02/02/2011 |
Locations
Countries of recruitment
- Australia
Study participating centre
Royal Children's Hospital
Herston
4029
Australia
4029
Australia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 29/03/2016 | Yes | No | |
| Protocol article | protocol | 09/08/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/03/2016: Publication reference added.
