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Trial registered on ANZCTR


Registration number
ACTRN12618000200280
Ethics application status
Approved
Date submitted
2/02/2018
Date registered
7/02/2018
Date last updated
7/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The intermittent fast diet for adolescents with obesity: a pilot study
Scientific title
Feasibility, acceptability and effectiveness of an intermittent modified fast diet to facilitate weight loss and ameliorate the underlying cardiometabolic risk factors in adolescents with obesity: a pilot study
Secondary ID [1] 293866 0
Nil known
Universal Trial Number (UTN)
U1111-1208-3537
Trial acronym
FAST Pilot Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 306329 0
Condition category
Condition code
Diet and Nutrition 305413 305413 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intermittent modified fast diet pilot study is a weight-loss intervention that aims to assess the feasibility and effectiveness of a modified alternate day fasting dietary pattern in adolescents with obesity.

The intervention will be delivered by a dietitian with experience seeing young people. Participants and a parent/guardian will meet face-to-face with the study dietitian at The Children's Hospital at Westmead at 8 time points across the 26 week intervention, with additional support provided via text messaging and phone calls at 8 time points. Visits at baseline, 12 and 26 weeks will be for approximately 3 hours with review visits in between of 20-30 minutes.

At baseline, participants will commence on the intermittent modified fast diet comprising of 3 Very Low Energy Diet (VLED) days per week, where they will consume 2-4 meal replacements or other food equivalents providing a total of 600-700kcal per day. On the other 4 days of the week participants will follow a standard recommended healthy diet based on Australian Dietary Guidelines. Participants will receive a food hamper free of charge containing their choice of the meal replacement and other food products required for the 3 VLED days per week during weeks 1-8. Participants will be provided with a meal plan to guide food choices throughout the study,

From weeks 9 to 12, participants will change from receiving meal replacements and other food products on the 3 VLED days per week to selecting and paying for their own food choices, still aiming to provide a total of 600-700kcal per day. The study dietitian will explain to each participant how to make this transition at the 8 week visit. In addition, participants will receive a nutrition resource containing detailed information on a wide variety of food choices. These will be in 100kcal portion sizes to help them calculate how much of the food they like to eat will make up 600-700kcal on each VLED day. This is an existing clinical resource used within The Children's Hospital at Westmead Adolescent Weight Management Clinic, and is available upon request from study investigators.

After 12 weeks on the diet, participants will be given the choice of one of four diets to follow:
(1) continue with the 3 VLED days per week plus 4 days per week of a standard healthy diet or
(2) 2 VLED days per week plus a standard healthy diet 5 days per week or
(3) one VLED day per week plus 6 days per week of a standard healthy diet or
(4) 7 days per week of a standard healthy diet.

Participants will be asked to keep a food diary on VLED days to assess dietary adherence. In addition, a dietitian led 24-hour recall will be conducted at baseline, 8, 12 and 26 weeks to assess dietary adherence and nutritional adequacy on VLED and standard healthy diet days.
Intervention code [1] 300126 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304548 0
Change in Body Mass Index. Body Mass Index will be calculated based on measured weight (kg) and height (m).
Timepoint [1] 304548 0
Baseline, 12 weeks (primary timepoint) and 26 weeks after intervention commencement.
Primary outcome [2] 304697 0
Feasibility of the intervention assessed by recruitment and eligibility rates, and rates of attendance and retention of recruited participants.
Timepoint [2] 304697 0
Recruitment and eligibility rates will be determined at baseline. Rates of attendance will be measured based on attendance at each scheduled visit. Retention rates will be determined at 26 weeks.
Secondary outcome [1] 342351 0
Acceptability of the intervention assessed using a standard participant interview and parent questionnaire designed for this study.
Timepoint [1] 342351 0
At 12 and 26 weeks after intervention commencement.
Secondary outcome [2] 342352 0
Change in body composition measured by bioelectrical impedance analysis (Tanita MC-180).
Timepoint [2] 342352 0
Baseline, 12 and 26 weeks after intervention commencement.
Secondary outcome [3] 342353 0
Change in blood pressure measured using an automated blood pressure monitor (Dinamap 1846 SX).
Timepoint [3] 342353 0
Baseline, 12 and 26 weeks after intervention commencement
Secondary outcome [4] 342354 0
Cardiovascular risk assessed by lipid profile and insulin sensitivity (glucose:insulin ratio) via collection of a 20mL fasting blood sample.
Timepoint [4] 342354 0
Baseline, 12 and 26 weeks after intervention commencement
Secondary outcome [5] 342355 0
Eating behaviours assessed using The Child Eating Behaviour Questionnaire.
Timepoint [5] 342355 0
Baseline, 12 and 26 weeks after intervention commencement
Secondary outcome [6] 342356 0
Quality of life assessed using the Pediatric Quality of Life Inventory (PedsQL) Version 4.0 Generic Core Scales questionnaire.
Timepoint [6] 342356 0
Baseline, 12 and 26 weeks after intervention commencement.
Secondary outcome [7] 342357 0
Vascular structure will be assessed by measuring flow-mediated dilation and carotid intima-media thickness by a trained operator according to standard procedures.
Timepoint [7] 342357 0
Baseline, 12 and 26 weeks after intervention commencement
Secondary outcome [8] 342825 0
Vascular function will be assessed by measuring pulse wave velocity by a trained operator according to standard procedures.
Timepoint [8] 342825 0
Baseline, 12 and 26 weeks after intervention commencement
Secondary outcome [9] 342837 0
Liver function assessed via collection of a 20mL fasting blood sample (same sample as outcome 4).
Timepoint [9] 342837 0
Baseline, 12 and 26 weeks after intervention commencement.

Eligibility
Key inclusion criteria
Obese (as defined by the International Obesity Task Force, Cole et al 2000) male and female adolescents aged 12 to 17 years.
Minimum age
12 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Type 1 diabetes or type 2 diabetes requiring insulin
Secondary causes of obesity
Psychiatric disturbance that would not allow the adolescent to give informed consent and/or would hinder the adolescent’s ability to comply with the study protocol
On weight loss medications or medications known to cause weight gain
Inability of the adolescent to speak English
Neither parent/carer speaks English

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
This is a pilot study so sample size and power calculations have not been used. The sample size has been determined based on the availability of funding and number of referrals likely to be received over a 12 months period.

Results will be presented as descriptive statistics. A paired t-test will be used in analysis of the primary outcome to assess change in body mass index from baseline to 12 weeks.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9906 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 18713 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 298485 0
Charities/Societies/Foundations
Name [1] 298485 0
Financial Markets Foundation for Children
Address [1] 298485 0
GPO Box 3655
Sydney NSW 2000
Country [1] 298485 0
Australia
Funding source category [2] 298539 0
Charities/Societies/Foundations
Name [2] 298539 0
Heart Foundation Vanguard Grant
Address [2] 298539 0
Level 3, 80 William Street
East Sydney NSW 2011
Country [2] 298539 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
Corner Hawkesbury Road and Hainsworth Street
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 297686 0
None
Name [1] 297686 0
Address [1] 297686 0
Country [1] 297686 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299472 0
Sydney Children's Hospital Network Human Research Ethics Committee
Ethics committee address [1] 299472 0
Corner Hawkesbury Road and Hainsworth Street
Westmead
Ethics committee country [1] 299472 0
Australia
Date submitted for ethics approval [1] 299472 0
Approval date [1] 299472 0
25/06/2014
Ethics approval number [1] 299472 0
HREC/14/SCHN/189

Summary
Brief summary
This study will examine the effect of a 12 week eating plan, an intermittent modified fast diet, that involves 3 days each week of a Very Low Energy Diet (VLED, consuming a very limited amount of food) and a healthy diet on the other 4 days, in adolescents with obesity. We think this diet will be more acceptable and therefore more likely to be adhered to by adolescents than a diet requiring them to limit their food every day. We speculate that this will result in body weight and body fat loss, and a reduction in cardiometabolic risk factors.

Adolescents with obesity will be invited to participate in the study by their clinician when attending Endocrinology, Dietetics or Weight Management services at The Children’s Hospital at Westmead. The details of the study will be explained to them and they will be given written information. If they agree to be in the study and their parent/carer also gives consent, a 3 hour appointment will be made for them to see the study dietitian, who will explain the diet and will measure their height, weight, waist circumference, blood pressure and percentage body fat. At baseline questionnaires on demographic, medical and family history will be completed by the parent/carer, and adolescents will complete questionnaires on their quality of life and eating behaviours. Adolescents will have vascular structure and function tests and have a fasting blood test to measure their blood sugar, insulin, blood fats and liver function at The Children’s Hospital at Westmead. All of these measurements, tests and questionnaires will be repeated at week 12 and at the final visit during week 26 of the study.

Participants will return to the hospital for appointments with the study dietitian at 2, 4, 8 and 12 weeks for their diet to be reviewed. The 12 week appointment will be for 3 hours during which they will have an interview with the study dietitian to determine how acceptable the diet was for them, as well as complete the measurements, tests and questionnaires as at the start of the study. During weeks 1, 3, 6, 9 and 11 of the study, adolescents will receive support from a dietitian via their choice of email, Short Messaging Service (SMS) or telephone call.

At the 12 week visit, adolescents will choose one of four diets to follow for weeks 13 to 26:
(1) Three VLED days per week plus 4 days of a healthy diet or
(2) Two VLED days per week plus 5 days of a healthy diet or
(3) One VLED day per week plus 6 days of a healthy diet or
(4) Seven days per week of a healthy diet

Participants will meet with the study dietitian at 16 and 20 weeks, and receive regular support up to the final visit. At 26 weeks from the start of the study, participants will return to the hospital for a final 3 hour visit during which they will have final measurements, testing and questionnaires completed, as well as an interview with the study dietitian about the acceptability of the diet chosen for the final 14 weeks of the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80522 0
A/Prof Sarah Garnett
Address 80522 0
Institute of Endocrinology and Diabetes
The Children's Hospital at Westmead
Corner Hawkesbury Road and Hainsworth Street
Westmead NSW
Country 80522 0
Australia
Phone 80522 0
+61 2 9845 0000
Fax 80522 0
Email 80522 0
sarah.garnett@health.nsw.gov.au
Contact person for public queries
Name 80523 0
Ms Hiba Jebeile
Address 80523 0
Institute of Endocrinology and Diabetes
The Children's Hospital at Westmead
Corner Hawkesbury Road and Hainsworth Street
Westmead NSW
Country 80523 0
Australia
Phone 80523 0
+61 2 9845 0000
Fax 80523 0
Email 80523 0
hiba.jebeile@health.nsw.gov.au
Contact person for scientific queries
Name 80524 0
Ms Hiba Jebeile
Address 80524 0
Institute of Endocrinology and Diabetes
The Children's Hospital at Westmead
Corner Hawkesbury Road and Hainsworth Street
Westmead NSW
Country 80524 0
Australia
Phone 80524 0
+61 2 9845 0000
Fax 80524 0
Email 80524 0
hiba.jebeile@health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary