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The intermittent fast diet for adolescents with obesity: a pilot study

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000200280
Acronym
FAST Pilot Study
Enrollment
30
Registered
2018-02-07
Start date
2015-03-16
Completion date
2017-02-21
Last updated
2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 pr

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.

Sponsors

The Children's Hospital at Westmead
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
12 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

Obese (as defined by the International Obesity Task Force, Cole et al 2000) male and female adolescents aged 12 to 17 years.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 2, 2026