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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]

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

Condition category

Condition code

Diet and Nutrition

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]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Change in Body Mass Index. Body Mass Index will be calculated based on measured weight (kg) and height (m).

Timepoint [1]

Baseline, 12 weeks (primary timepoint) and 26 weeks after intervention commencement.

Primary outcome [2]

Feasibility of the intervention assessed by recruitment and eligibility rates, and rates of attendance and retention of recruited participants.

Timepoint [2]

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]

Acceptability of the intervention assessed using a standard participant interview and parent questionnaire designed for this study.

Timepoint [1]

At 12 and 26 weeks after intervention commencement.

Secondary outcome [2]

Change in body composition measured by bioelectrical impedance analysis (Tanita MC-180).

Timepoint [2]

Baseline, 12 and 26 weeks after intervention commencement.

Secondary outcome [3]

Change in blood pressure measured using an automated blood pressure monitor (Dinamap 1846 SX).

Timepoint [3]

Baseline, 12 and 26 weeks after intervention commencement

Secondary outcome [4]

Cardiovascular risk assessed by lipid profile and insulin sensitivity (glucose:insulin ratio) via collection of a 20mL fasting blood sample.

Timepoint [4]

Baseline, 12 and 26 weeks after intervention commencement

Secondary outcome [5]

Eating behaviours assessed using The Child Eating Behaviour Questionnaire.

Timepoint [5]

Baseline, 12 and 26 weeks after intervention commencement

Secondary outcome [6]

Quality of life assessed using the Pediatric Quality of Life Inventory (PedsQL) Version 4.0 Generic Core Scales questionnaire.

Timepoint [6]

Baseline, 12 and 26 weeks after intervention commencement.

Secondary outcome [7]

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]

Baseline, 12 and 26 weeks after intervention commencement

Secondary outcome [8]

Vascular function will be assessed by measuring pulse wave velocity by a trained operator according to standard procedures.

Timepoint [8]

Baseline, 12 and 26 weeks after intervention commencement

Secondary outcome [9]

Liver function assessed via collection of a 20mL fasting blood sample (same sample as outcome 4).

Timepoint [9]

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

Sex

Both males and females

Can healthy volunteers participate?

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

16/03/2015

Date of last participant enrolment

Anticipated

Actual

21/02/2017

Date of last data collection

Anticipated

Actual

29/08/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

The Children's Hospital at Westmead - Westmead

Recruitment postcode(s) [1]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Financial Markets Foundation for Children

Address [1]

GPO Box 3655
Sydney NSW 2000

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Heart Foundation Vanguard Grant

Address [2]

Level 3, 80 William Street
East Sydney NSW 2011

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Children's Hospital Network Human Research Ethics Committee

Ethics committee address [1]

Corner Hawkesbury Road and Hainsworth Street
Westmead

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

25/06/2014

Ethics approval number [1]

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

A/Prof Sarah Garnett

Address

Institute of Endocrinology and Diabetes
The Children's Hospital at Westmead
Corner Hawkesbury Road and Hainsworth Street
Westmead NSW

Country

Australia

Phone

+61 2 9845 0000

Fax

[email protected]

Contact person for public queries

Name

Hiba Jebeile

Address

Institute of Endocrinology and Diabetes
The Children's Hospital at Westmead
Corner Hawkesbury Road and Hainsworth Street
Westmead NSW

Country

Australia

Phone

+61 2 9845 0000

Fax

[email protected]

Contact person for scientific queries

Name

Hiba Jebeile

Address

Institute of Endocrinology and Diabetes
The Children's Hospital at Westmead
Corner Hawkesbury Road and Hainsworth Street
Westmead NSW

Country

Australia

Phone

+61 2 9845 0000

Fax

[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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Intermittent energy restriction is a feasible, effective, and acceptable intervention to treat adolescents with obesity.	2019	https://dx.doi.org/10.1093/jn/nxz049

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically