Letter to Members: ANZAED position on the Fast Track Trial
19 February, 2019
Many of you would have seen the article “Extreme low-calorie diet for teenagers could be linked to depression’’ published online last Wednesday by the Sydney Morning Herald, reporting on a research trial (Fast Track) examining the effects of alternate day fasting on adolescents’ weight loss. The Executive committee has taken time to deliberate carefully, consider the diverse views of our membership, obtain further information about the trial and provide a considered response.
The Australia & New Zealand Academy for Eating Disorders (ANZAED) has very strong concerns about the level of energy restriction being undertaken in this trial. Specifically, ANZAED is concerned that the daily energy intake is much too low for growing adolescents and that the pattern of energy intake established in this trial may lead to difficulties in eating patterns in the future for participants in the trial.
Research in community samples and epidemiological studies shows that dieting is a strong risk factor for the development of eating disorders. We acknowledge that a small number of medically managed weight intervention trials have not demonstrated a short-term risk of restriction on eating disorder development, however the longer-term effects remain unknown
In addition, the article reported that a complaint was made to the Sydney Children’s Hospital Network Human Research Ethics Committee by a group of 29 eating disorder professionals. The executive officer of research ethics, Ms Asra Gholami, responded,
“The HREC recognises that there is a risk for a young person to develop an eating disorder with exposure to restrictive diets, and in particular very restrictive diets. Although these risks appear to be lower in medically supervised dieting programs, they will still be present.”
The risks of developing an eating disorder were reportedly deemed to be justified on the basis of likely benefits of the trial and the inclusion of a risk management plan that would minimise risks and communicate risks associated with potential eating disorder development to participants and their parents/guardians. ANZAED is highly concerned about this justification. Eating disorders have the highest mortality rate of any mental illness, with onset common during adolescence. With consideration of these points, it is ANZAED’s position that the risk of developing an eating disorder is not warranted in this or any other research trial.
Acknowledging the cost and severity of eating disorders in the community, in December 2018 the federal government committed $110 million in Medicare funding to treat these debilitating conditions. To build on the work of our government, it is important that researchers and ethics committees are committed to ensuring that research trials do not unintentionally make our national problem worse.
It is understood that the research investigators within this trial state there is evidence that modified alternate day fasting has achieved weight loss in adults, however there is a lack of evidence that this is sustained long term. Furthermore, restrictive dieting has consistently been shown to be ineffective in achieving sustained weight loss. ANZAED is greatly concerned that an approach that has not yet shown long-term sustainability in adults is being ‘tested’ in a vulnerable adolescent population at high risk of developing an eating disorder.
As a result of careful consideration of the points raised above, ANZAED does not support this trial of an extremely low calorie weight loss intervention in adolescents.
We ask the researchers and their respective ethics committee to reconsider the cost/benefit analysis of this trial. We understand that the researchers have updated the participant and parent information sheet to indicate that there may be a minimal risk of increased eating disorders from engagement in restrictive dieting. Although this is an improvement on the previous information sheet, it does appear to downplay the possibility of an eating disorder developing. It is ANZAED’s position that these risks need to be more clearly and boldly stated in the participant and parent information sheets, and on the trial website.
ANZAED has expressed its concerns to the trial’s investigators and will seek ongoing communication with the researchers to help mitigate the risk of eating disorder development.
Yours sincerely,
The Executive Committee
Australia & New Zealand Academy for Eating Disorders (ANZAED)
If you have any comments or concerns, please email them to admin@anzaed.org.au
19 February, 2019
Many of you would have seen the article “Extreme low-calorie diet for teenagers could be linked to depression’’ published online last Wednesday by the Sydney Morning Herald, reporting on a research trial (Fast Track) examining the effects of alternate day fasting on adolescents’ weight loss. The Executive committee has taken time to deliberate carefully, consider the diverse views of our membership, obtain further information about the trial and provide a considered response.
The Australia & New Zealand Academy for Eating Disorders (ANZAED) has very strong concerns about the level of energy restriction being undertaken in this trial. Specifically, ANZAED is concerned that the daily energy intake is much too low for growing adolescents and that the pattern of energy intake established in this trial may lead to difficulties in eating patterns in the future for participants in the trial.
Research in community samples and epidemiological studies shows that dieting is a strong risk factor for the development of eating disorders. We acknowledge that a small number of medically managed weight intervention trials have not demonstrated a short-term risk of restriction on eating disorder development, however the longer-term effects remain unknown
In addition, the article reported that a complaint was made to the Sydney Children’s Hospital Network Human Research Ethics Committee by a group of 29 eating disorder professionals. The executive officer of research ethics, Ms Asra Gholami, responded,
“The HREC recognises that there is a risk for a young person to develop an eating disorder with exposure to restrictive diets, and in particular very restrictive diets. Although these risks appear to be lower in medically supervised dieting programs, they will still be present.”
The risks of developing an eating disorder were reportedly deemed to be justified on the basis of likely benefits of the trial and the inclusion of a risk management plan that would minimise risks and communicate risks associated with potential eating disorder development to participants and their parents/guardians. ANZAED is highly concerned about this justification. Eating disorders have the highest mortality rate of any mental illness, with onset common during adolescence. With consideration of these points, it is ANZAED’s position that the risk of developing an eating disorder is not warranted in this or any other research trial.
Acknowledging the cost and severity of eating disorders in the community, in December 2018 the federal government committed $110 million in Medicare funding to treat these debilitating conditions. To build on the work of our government, it is important that researchers and ethics committees are committed to ensuring that research trials do not unintentionally make our national problem worse.
It is understood that the research investigators within this trial state there is evidence that modified alternate day fasting has achieved weight loss in adults, however there is a lack of evidence that this is sustained long term. Furthermore, restrictive dieting has consistently been shown to be ineffective in achieving sustained weight loss. ANZAED is greatly concerned that an approach that has not yet shown long-term sustainability in adults is being ‘tested’ in a vulnerable adolescent population at high risk of developing an eating disorder.
As a result of careful consideration of the points raised above, ANZAED does not support this trial of an extremely low calorie weight loss intervention in adolescents.
We ask the researchers and their respective ethics committee to reconsider the cost/benefit analysis of this trial. We understand that the researchers have updated the participant and parent information sheet to indicate that there may be a minimal risk of increased eating disorders from engagement in restrictive dieting. Although this is an improvement on the previous information sheet, it does appear to downplay the possibility of an eating disorder developing. It is ANZAED’s position that these risks need to be more clearly and boldly stated in the participant and parent information sheets, and on the trial website.
ANZAED has expressed its concerns to the trial’s investigators and will seek ongoing communication with the researchers to help mitigate the risk of eating disorder development.
Yours sincerely,
The Executive Committee
Australia & New Zealand Academy for Eating Disorders (ANZAED)
If you have any comments or concerns, please email them to admin@anzaed.org.au