Early detection and intervention of anorexia nervosa
| ISRCTN | ISRCTN18614564 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18614564 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/01/2012
- Registration date
- 12/03/2012
- Last edited
- 17/12/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Anorexia nervosa (AN) is a burden for both the affected persons and their families. It typically manifests during late childhood or early adolescence mostly in females. In many cases the disorder has a chronic course and about one patient in ten dies due to AN. Therefore, it is important to develop ways of preventing AN. Previous studies have shown that internet-based preventive interventions can help reducing such risk factors for eating disorders (ED). There are a few studies about bulimia nervosa and binge eating disorder but there are no studies for AN. and this is the aim of this research. We want to explore how many girls and adolescents are at risk for AN. Our online program E@T (Eltern als Therapeuten; German version of P@N - Parents Act Now, Stanford University School of Medicine) was developed for parents of females aged 11 to 17 at risk for AN. In 6 weekly sessions parents are educated about the danger of AN and the need to intervene early. In addition, they are encouraged to take definitive steps to intervene in case of any weight loss efforts (e.g. dieting, excessive participation in physical activities) in order to prevent the deterioration of these behaviors and/or potential medical and psychological problems. An online program can facilitate dissemination, be readily adapted and updated, provide contents 24h a day, permit interactivity and eventually reduce costs.
Who can participate?
Every female aged 11 to 17 years can take part in the study when she has a combination of selected risk factors (e.g. excessive participation in physical activities, strong weight and shape concerns) and/or early symptoms of AN (e.g. lower than 90% of her ideal body weight, amenorrhea).
What does the study involve?
We follow a two-step procedure. At first we are screening young females at risk through questionnaires at schools. Then the parents get the opportunity to take part in an internet-based prevention program. When a girl or adolescent fulfills the inclusion criteria her family is randomly allocated to the intervention group or the control group. In the intervention group, a short internet-based prevention program is offered. The intervention consists of an online program for parents with 6 sessions over 6 weeks moderated by eating disorder experts (qualified psychologists). At the end of the program there is a post interview as well as 4 follow-up interviews every 6 months. The control group does not get access to the online program.
What are the possible benefits and risks of participating?
If parents are included in the intervention group they are educated on the danger of AN and encouraged to take steps against weight loss efforts (dieting, diet pills, excessive exercise) in order to prevent the deterioration of these behaviors and/or medical and psychological problems. In the follow-up interviews parents that are included in the control group get information about their daughter's risk status. There are no known risks or side effects for participants.
Where is the study run from?
The study is run from Dresden, Germany and recruitment is done in Saxony (Eastern German state where Dresden is located), but because our intervention is internet-based and interviews can take place over the phone, participants from the whole of Germany can take part.
When is the study starting and how long is it expected to run for?
The study started in February 2010 and recruitment will continue until December 2012.
Who is funding the study?
The study is funded by the Swiss Anorexia Nervosa Fundation (SANS).
Who is the main contact?
Prof. Dr. Corinna Jacobi
cjacobi@psychologie.tu-dresden.de
Contact information
Scientific
Technische Universität Dresden
Insitute of Clinical Psychology and Psychotherapy
Dresden
01187
Germany
| cjacobi@psychologie.tu-dresden.de |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Early detection and intervention of anorexia nervosa in adolescent girls: a randomized controlled trial comparing a family-oriented, internet-based intervention with a control group without intervention |
| Study hypothesis | P@N - Parents Act Now [German: E@T - Eltern als Therapeuten]. The intervention should normalize weight (Ideal Body Weight (IBW)) and reduce the targeted potent risk factors and retrospective correlates Eating Disorder Examination (EDE) weight and shape concerns, EDE restraint, Eating Disorder Inventory (EDI) drive for thinness, EDI body dissatisfaction, driven exercise, perfectionism, self-esteem and perfectionism short term (post-treatment) and long term (follow-up). |
| Ethics approval(s) | Ethics Committee, Faculty of Medicine Carl Gustav Carus, Technical University of Dresden [Technische Universität Dresden], 07/06/2010, ref: EK172052010 |
| Condition | Anorexia nervosa |
| Intervention | Randomized controlled trial comparing a 6-week intervention group to a monitored, non-intervention control group with outcome comparison at post-treatment and every 6 months E@T (Eltern als Therapeuten; German version of P@N - Parents Act Now, Stanford Medical School). The intervention consists of an online program for parents of adolescent daughters with 6 sessions over 6 weeks moderated by eating disorder experts (e.g. diploma-level psychologists). Parents are educated on the danger of AN and the need to intervene to prevent this outcome. In addition, parents are encouraged to take definitive steps to intervene with any weight loss efforts (dieting, diet pills, over exercise) in order to prevent the elaboration of these behaviors with an attendant escalation in medical and psychological problems. Additional features are an online discussion group, two phone calls to enable individualized feedback on the child's problems with eating, weight and shape, and referral to other resources (self-help-guide, Lock & Le Grange, 2006); in- or outpatient treatment) if necessary. We favor an online program because such programs increase ease of dissemination, can be readily adapted and updated, provide contents 24 hours/day, permit interactivity and other multimedia functions (e.g. videos) to make the program more attractive to consumers, generate an automatic data base on adherence, and eventually reduce cost. The outcomes will be compared at post-treatment and every 6 months for 2 years (follow-up). |
| Intervention type | Other |
| Primary outcome measure | AN symptoms: 1. Weight normalization - chnages in BMI 2. Weight and shape concerns, eating concerns, restraint (restricitive eating): Eating Disorder Examination (EDE, interview) |
| Secondary outcome measures | 1. Risk status (as described in inclusion criteria, questionnaire) 2. Full or partial AN diagnoses: Eating Disorder Examination (EDE, interview) 3. Drive for thinness, body dissatisfaction: Eating Disorder Inventory 2 (EDI-2, questionnaire) 4. Self-esteem: Rosenberg Self-Esteem Scale (RSE, questionnaire) 5. Depression: Beck's Depression Inventory II (BDI-II, questionnaire) 6. Perfectionism: Frost Multidimensional Perfectionism Scale (MPS-F, questionnaire) 7. Social adjustment: Social Adjustment Scale (SAS, German version: Fragebogen zur sozialen Integration, FSI, questionnaire) |
| Overall study start date | 01/02/2010 |
| Overall study end date | 01/02/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 17 Years |
| Sex | Female |
| Target number of participants | 100 high risk subjects |
| Participant inclusion criteria | 1. Female 2. Age 11 - 17 years 3. Informed consent by adolescent girl and their parents 4. Being at high risk for anorexia nervosa (AN), meaning to fulfill the combination AB or BC or ABC of the following variables: A. High weight and shape concerns B. Low weight (below 90% IBW) or normal weight (90-115% IBW) but weight loss of at least 5% in the past 6 months or >115% IBW but weight loss of at least 10% in the past 6 months C. Presence of at least one the following risk factors: High-level perfectionism, family history of ED, driven exercise (excessive engagement in physical activities) or primary or secondary amenorrhea |
| Participant exclusion criteria | 1. Current full eating disorder diagnosis 2. Treatment for ED within the past six months 3. Acute suicidal ideation 4. Drug or alcohol abuse or dependence |
| Recruitment start date | 01/02/2010 |
| Recruitment end date | 01/12/2012 |
Locations
Countries of recruitment
- Germany
Study participating centre
01187
Germany
Sponsor information
Government
Klünenfeldstrasse 22
Birsfelden
CH - 4127
Switzerland
| Website | http://www.anorexia-nervosa.ch/ |
|---|---|
"ROR" |
https://ror.org/00kb3m272 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 14/12/2018 | Yes | No |
Editorial Notes
17/12/2018: Publication reference added.
