Eating DisordersNCT00042185
Eating Disorder Prevention Programs
A study testing Dissonance Eating Disorder Prevention Program and Healthy Weight Intervention in people with Eating Disorders, run by University of Texas at Austin at 1 site in United States.
Trial summary
This study evaluated 2 eating disorder prevention programs designed to increase body satisfaction among adolescent females with body image concerns. Read more about this study
- Who is it for?
- Ages 14 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Dissonance Eating Disorder Prevention Program and Healthy Weight Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2001to May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Self-reported body image concerns
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Austin Body Acceptance Study
This study evaluated 2 eating disorder prevention programs designed to increase body satisfaction among adolescent females with body image concerns.
Read the detailed description
Adolescent girls with body dissatisfaction (N=481; SD=1.4) were randomized to a dissonance-based thin-ideal internalization reduction program, healthy weight control program, expressive-writing control condition, or assessment-only control condition. Dissonance participants showed significantly greater decreases in thin-ideal internalization, body dissatisfaction, negative affect, eating disorder symptoms, and psychosocial impairment, and lower risk for eating pathology onset through 2-3 year follow-up than assessment-only controls. Dissonance participants showed greater decreases in thin-ideal internalization, body dissatisfaction, and psychosocial impairment than expressive-writing controls. Healthy weight participants showed greater decreases in thin-ideal internalization, body dissatisfaction, negative affect, eating disorder symptoms, and psychosocial impairment, less increases in weight, and lower risk for eating pathology and obesity onset through 2-3 year follow-up than assessment-only controls. Healthy weight participants showed greater decreases in thin-ideal internalization and weight than expressive writing controls. Dissonance participants showed a 60% reduction in risk for eating pathology onset and healthy weight participants showed a 61% reduction in risk for eating pathology onset and a 55% reduction in risk for obesity onset relative to assessment-only controls through 3-year follow-up, implying that the effects are clinically important and enduring.
- Conditions
- Eating Disorders
- Being tested
- Dissonance Eating Disorder Prevention Program, Healthy Weight Intervention, Expressive Writing Control Condition
- Keywords
- Adolescence, Prevention and Control, Bulimia
- Medical subject headings
- Feeding and Eating Disorders, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dissonance Eating Disorder Prevention ProgramBehavioural
In this intervention, participants voluntarily engaged in verbal, written, and behavioral exercises in which they critiqued the thin-ideal ideal. These exercises were conducted in sessions and in homework activities. For example, they wrote a counter-attitudinal essay about the costs associated with pursuit of the thin-ideal and engaged in a counter-attitudinal role-play in which they attempted to dissuade facilitators from pursuing the thin-ideal.
Healthy Weight InterventionBehavioural
In this intervention, participants were encouraged to make gradual healthy and lasting changes to their diet and physical activity to balance their energy needs with their energy intake, and thereby achieve a healthier weight and body satisfaction. With support from the facilitator and group members, they initiated an individual lifestyle change plan to reduce intake of fat and sugar and to increase exercise using behavioral modification principles. Food and exercise diaries were used to identify behaviors to target in this lifestyle modification and to monitor change. Motivational enhancement activities were used to promote motivation for behavior change.
Expressive Writing Control ConditionBehavioural
In this condition, which is based on the work of Pennebaker (1997), participants wrote about emotionally significant topics in three individual weekly 45-minute sessions. They were told that research indicates that body dissatisfaction is linked to emotional issues and that expressive writing helps resolve these issues. Sample topics included relationships or goals. They were told that their work would not be read and were asked to write continuously for the duration of the session about an emotionally important topic.
| Study group | Role | What they receive |
|---|---|---|
| Dissonance intervention | Experimental | Not described Receives: Behavioral: Dissonance Eating Disorder Prevention Program |
| Healthy Weight Intervention | Active comparator | Not described Receives: Behavioral: Healthy Weight Intervention |
| Expressive writing control intervention | Active comparator | Not described Receives: Behavioral: Expressive Writing Control Condition |
| Assessment-only control condition | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Diagnostic Interview
Measured: 1 year
Secondary outcomes (1)
The Ideal-Body Stereotype Scale-Revised, Satisfaction and Dissatisfaction with Body Parts Scale, Positive Affect and Negative Affect Scale-Revised
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2002 (estimated)
- Study startFeb 2001
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00042185
- Sponsor's protocol ID
- R01MH061957
- Other IDs
- R01MH061957, DSIR 84-CTP
- Status last verified
- Sep 2013
- First submitted
- 24 Jul 2002
- Last updated
- 27 Sep 2013
- Results posted
- No
Publications
Stice E, Shaw H. Eating disorder prevention programs: a meta-analytic review. Psychol Bull. 2004 Mar;130(2):206-27. doi: 10.1037/0033-2909.130.2.206.
PubMed 14979770Stice E, Fisher M, Martinez E. Eating disorder diagnostic scale: additional evidence of reliability and validity. Psychol Assess. 2004 Mar;16(1):60-71. doi: 10.1037/1040-3590.16.1.60.
PubMed 15023093
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Austin Body Acceptance Study
- ClinicalTrials.gov ID
- NCT00042185
- Acronym / sponsor ID
- R01MH061957
- Conditions
- Eating Disorders
- Keywords
- Adolescence, Prevention and Control, Bulimia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2001
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 26 Jul 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated 2 eating disorder prevention programs designed to increase body satisfaction among adolescent females with body image concerns.
Detailed description
Adolescent girls with body dissatisfaction (N=481; SD=1.4) were randomized to a dissonance-based thin-ideal internalization reduction program, healthy weight control program, expressive-writing control condition, or assessment-only control condition. Dissonance participants showed significantly greater decreases in thin-ideal internalization, body dissatisfaction, negative affect, eating disorder symptoms, and psychosocial impairment, and lower risk for eating pathology onset through 2-3 year follow-up than assessment-only controls. Dissonance participants showed greater decreases in thin-ideal internalization, body dissatisfaction, and psychosocial impairment than expressive-writing controls. Healthy weight participants showed greater decreases in thin-ideal internalization, body dissatisfaction, negative affect, eating disorder symptoms, and psychosocial impairment, less increases in weight, and lower risk for eating pathology and obesity onset through 2-3 year follow-up than assessment-only controls. Healthy weight participants showed greater decreases in thin-ideal internalization and weight than expressive writing controls. Dissonance participants showed a 60% reduction in risk for eating pathology onset and healthy weight participants showed a 61% reduction in risk for eating pathology onset and a 55% reduction in risk for obesity onset relative to assessment-only controls through 3-year follow-up, implying that the effects are clinically important and enduring.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dissonance intervention | Experimental | Behavioral: Dissonance Eating Disorder Prevention Program |
| Healthy Weight Intervention | Active comparator | Behavioral: Healthy Weight Intervention |
| Expressive writing control intervention | Active comparator | Behavioral: Expressive Writing Control Condition |
| Assessment-only control condition | No intervention | – |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Self-reported body image concerns
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dissonance Eating Disorder Prevention ProgramIn this intervention, participants voluntarily engaged in verbal, written, and behavioral exercises in which they critiqued the thin-ideal ideal. These exercises were conducted in sessions and in homework activities. For example, they wrote a counter-attitudinal essay about the costs associated with pursuit of the thin-ideal and engaged in a counter-attitudinal role-play in which they attempted to dissuade facilitators from pursuing the thin-ideal. | Behavioural | Dissonance intervention |
| Healthy Weight InterventionIn this intervention, participants were encouraged to make gradual healthy and lasting changes to their diet and physical activity to balance their energy needs with their energy intake, and thereby achieve a healthier weight and body satisfaction. With support from the facilitator and group members, they initiated an individual lifestyle change plan to reduce intake of fat and sugar and to increase exercise using behavioral modification principles. Food and exercise diaries were used to identify behaviors to target in this lifestyle modification and to monitor change. Motivational enhancement activities were used to promote motivation for behavior change. | Behavioural | Healthy Weight Intervention |
| Expressive Writing Control ConditionIn this condition, which is based on the work of Pennebaker (1997), participants wrote about emotionally significant topics in three individual weekly 45-minute sessions. They were told that research indicates that body dissatisfaction is linked to emotional issues and that expressive writing helps resolve these issues. Sample topics included relationships or goals. They were told that their work would not be read and were asked to write continuously for the duration of the session about an emotionally important topic. | Behavioural | Expressive writing control intervention |
Primary outcome
Eating Disorder Diagnostic Interview
Time frame: 1 year
1 secondary outcome
The Ideal-Body Stereotype Scale-Revised, Satisfaction and Dissatisfaction with Body Parts Scale, Positive Affect and Negative Affect Scale-Revised
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2013.
- Background: PubMed 14979770Stice E, Shaw H. Eating disorder prevention programs: a meta-analytic review. Psychol Bull. 2004 Mar;130(2):206-27. doi: 10.1037/0033-2909.130.2.206.
- Background: PubMed 15023093Stice E, Fisher M, Martinez E. Eating disorder diagnostic scale: additional evidence of reliability and validity. Psychol Assess. 2004 Mar;16(1):60-71. doi: 10.1037/1040-3590.16.1.60.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dissonance Eating Disorder Prevention Program and Healthy Weight Intervention in people with Eating Disorders, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Diagnostic Interview (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00042185, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2013.