Disordered Eating BehaviorsNCT03612661
Piloting a Novel Intuitive Eating Intervention for College Women With Disordered Eating
A study testing Group Intervention and Guided Self-Help in people with Disordered Eating Behaviors, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this research study is to pilot test a new intervention that helps young adult women learn adaptive eating and exercise strategies, increase their body acceptance, decrease unhealthy weight control behaviors and prevent future eating and problems. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Disordered Eating Behaviors
- What is being tested?
- Group Intervention and Guided Self-Help
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2018to 19 Jun 2019
- 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 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Not currently pregnant
- Enrolled in postsecondary education at VCU
- Have body image or eating concerns
Who cannot join
- Eating disorder threshold risk
- Men
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The purpose of this research study is to pilot test a new intervention that helps young adult women learn adaptive eating and exercise strategies, increase their body acceptance, decrease unhealthy weight control behaviors and prevent future eating and problems. This intervention is experimental, and the study will test its feasibility, acceptability, and effectiveness.
Read the detailed description
The intervention, Intuitive Eating, is an eating approach that addresses important risk factors and promotes adaptive eating attitudes and behaviors. It has three central tenets: 1) unconditional permission to eat when hungry, 2) eating for physical rather than emotional reasons, and 3) eating according to hunger and satiety cues. Intuitive Eating has ten principles that focus on rejecting the dieting mentality, honoring hunger cues, decreasing restrictive behaviors that lead to deprivation and bingeing, challenging rigid food rules, increasing awareness of satiety, discovering the satisfaction of food, coping with emotions without food, respecting and accepting one's body, using exercise as self-care, and balancing nutrition with satisfaction.
- Conditions
- Disordered Eating Behaviors
- Being tested
- Group Intervention, Guided Self-Help
- Keywords
- disordered eating, body image, intuitive eating, undergraduates, college, unhealthy weight control behaviors, eating disorders, weight stigma, weight bias
- Medical subject headings
- Disordered Eating Behavior, Feeding and Eating Disorders, Weight Prejudice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group InterventionBehavioural
Participants in the group intervention will attend eight weekly, 90-minute sessions involving group activities and discussions. They will complete homework between sessions to reinforce learning. The intervention focuses on cultivating attunement to bodily sensations and fostering self-compassion to improve physical and mental health.
Guided Self-HelpBehavioural
Participants in the GSH condition will follow the intuitive eating content through self-guided study, with eight weekly scheduled phone calls with an interventionist (~20 minutes each). Interventionists will review homework assignments, answer questions, and reinforce adherence. The intervention materials are the same as the group and also focus on cultivating attunement to bodily sensations and fostering self-compassion to improve physical and mental health.
| Study group | Role | What they receive |
|---|---|---|
| Intuitive Eating Group Intervention | Experimental | Intuitive eating intervention delivered in a group format with 8-10 women, led by 2 facilitators. Receives: Behavioral: Group Intervention |
| Intuitive Eating Guided Self-Help | Experimental | Participants in this condition engage in 8 weeks of self-study of the intuitive eating intervention have ~20 minute weekly phone call with a study interventionist. Receives: Behavioral: Guided Self-Help |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diagnostic eating disorder symptoms
The Eating Disorder Diagnostic Scale (EDDS) is a brief self-report measure that screens for the presence of subthreshold or threshold levels of ED symptoms. It yields a symptom composite score, to be used as the primary outcome measure. Items assessing body dissatisfaction, overvaluation of shape/weight, and impairment are measured on a 0 to 6-point scale with higher ratings indicating greater body dissatisfaction. Items evaluating the presence of compensatory behaviors and binge eating are rated yes/no and participants indicate the frequency these behaviors have occurred in the prior 3 months.
Measured: Baseline to 16 weeks
Change in global eating disorder symptoms
The EDE-Q is a 28-item self-report version of the Eating Disorder Examination that measures frequency of disordered eating cognitions and behaviors experienced in the previous 28 days. Participants rate the number of days behaviors have occurred in the last 28 days, with 0 = no days and 6 = every day. Yes/no questions identify the presence of compensatory and binge behaviors and participants indicate the frequency of these behaviors over the last 28 days. Higher EDE-Q scores indicate greater eating pathology.
Measured: Baseline to 16 weeks
Changes in intuitive eating
The Intuitive Eating Scale-2 (IES-2) is a 23-item self-report measure of intuitive eating with three subscales: Unconditional Permission to Eat, Eating for Physical Rather Than Emotional Reasons, and Reliance on Hunger and Satiety Cues. Items are rated on a 1 to 5-point scale with higher scores indicating higher levels of intuitive eating.
Measured: Baseline to 16 weeks
Secondary outcomes (7)
Change in body appreciation
The Body Appreciation Scale-2 (BAS-2) is a 10-item measure of positive body image. Specifically, it assesses body appreciation, which reflects acceptance of and favorable opinions and respect towards one's body and a rejection of the narrow beauty ideals promoted through mass media. Items are rated on a 5-point scale with higher scores indicating greater body appreciation.
Measured: Baseline to 16 weeks
Changes in dietary restraint
The Dutch Restrained Eating Scale (DRES) contains 10 items that measure dietary restraint for the purpose of weight loss. Items are rated on a 5-point scale with higher scores reflecting greater dietary restraint.
Measured: Baseline to 16 weeks
Changes in body functionality appreciation
The Functionality Appreciation Scale (FAS) is a 7-item scale that measures appreciation for the functionality of one's body, which is believed to help offset appearance concerns. Items are rated on a 5-point scale with higher scores reflecting greater appreciation for the functionality of one's body.
Measured: Baseline to 16 weeks
Changes in interoceptive awareness
The Interoceptive Awareness subscale of the EDI-3 has 10 items that measure an individual's attunement to their internal state, including perceptions of emotions, hunger, and satiety. Items are rated on a 6-point scale, with higher scores reflecting greater deficits in interoceptive awareness.
Measured: Baseline to 16 weeks
Changes in intuitive exercise
The Intuitive Exercise Scale (IEXS) measures adaptive exercise behaviors that are guided by physical cues and flexibility rather than rigid rules or feelings of obligation. Items are rated on a 5-point scale, with higher scores reflecting more intuitive exercise behaviors.
Measured: Baseline to 16 weeks
Changes in weight bias internalization
The Modified Weight Bias Internalization Scale (WBIS-M) is a modified version of the Weight Bias Internalization Scale that was adapted for use with individuals across the weight spectrum. The WBIS-M measures the degree to which individuals apply weight-based stereotypes to themselves and use those to guide their weight self-evaluations. Items are rated on a 7-point scale, with higher scores reflecting greater degrees of weight bias internalization.
Measured: Baseline to 16 weeks
Changes in satisfaction with life
The Satisfaction with Life Scale (SWLS) is a 5-item scale that assesses global life satisfaction. Items are scored on a 7-point scale, with higher scores reflecting greater life satisfaction.
Measured: Baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start14 Sep 2018
- Primary completion19 Jun 2019
- Study completion19 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disordered Eating BehaviorsStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either a group or guided self-help condition, of the same intervention, intuitive eating, of the same duration (8 weeks).
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne Mazzeo, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612661
- Sponsor's protocol ID
- HM20012263
- Status last verified
- Aug 2019
- First submitted
- 27 Jul 2018
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be available by researcher request only after study completion. Interested researchers can email the primary study contact.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting a Novel Intuitive Eating Intervention for College Women With Disordered Eating
- ClinicalTrials.gov ID
- NCT03612661
- Acronym / sponsor ID
- HM20012263
- Conditions
- Disordered Eating Behaviors
- Keywords
- disordered eating, body image, intuitive eating, undergraduates, college, unhealthy weight control behaviors, eating disorders, weight stigma, weight bias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 2 Aug 2018 (actual)
- 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.
The purpose of this research study is to pilot test a new intervention that helps young adult women learn adaptive eating and exercise strategies, increase their body acceptance, decrease unhealthy weight control behaviors and prevent future eating and problems. This intervention is experimental, and the study will test its feasibility, acceptability, and effectiveness.
Detailed description
The intervention, Intuitive Eating, is an eating approach that addresses important risk factors and promotes adaptive eating attitudes and behaviors. It has three central tenets: 1) unconditional permission to eat when hungry, 2) eating for physical rather than emotional reasons, and 3) eating according to hunger and satiety cues. Intuitive Eating has ten principles that focus on rejecting the dieting mentality, honoring hunger cues, decreasing restrictive behaviors that lead to deprivation and bingeing, challenging rigid food rules, increasing awareness of satiety, discovering the satisfaction of food, coping with emotions without food, respecting and accepting one's body, using exercise as self-care, and balancing nutrition with satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to either a group or guided self-help condition, of the same intervention, intuitive eating, of the same duration (8 weeks).
| Arm | Type | Receives |
|---|---|---|
| Intuitive Eating Group Intervention | Experimental | Behavioral: Group InterventionIntuitive eating intervention delivered in a group format with 8-10 women, led by 2 facilitators. |
| Intuitive Eating Guided Self-Help | Experimental | Behavioral: Guided Self-HelpParticipants in this condition engage in 8 weeks of self-study of the intuitive eating intervention have ~20 minute weekly phone call with a study interventionist. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Not currently pregnant
- Enrolled in postsecondary education at VCU
- Have body image or eating concerns
Key exclusion criteria (3 listed)
- Eating disorder threshold risk
- Men
- Pregnant women
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 |
|---|---|---|
| Group InterventionParticipants in the group intervention will attend eight weekly, 90-minute sessions involving group activities and discussions. They will complete homework between sessions to reinforce learning. The intervention focuses on cultivating attunement to bodily sensations and fostering self-compassion to improve physical and mental health. | Behavioural | Intuitive Eating Group Intervention |
| Guided Self-HelpParticipants in the GSH condition will follow the intuitive eating content through self-guided study, with eight weekly scheduled phone calls with an interventionist (~20 minutes each). Interventionists will review homework assignments, answer questions, and reinforce adherence. The intervention materials are the same as the group and also focus on cultivating attunement to bodily sensations and fostering self-compassion to improve physical and mental health. | Behavioural | Intuitive Eating Guided Self-Help |
Primary outcome
Change in diagnostic eating disorder symptoms
Time frame: Baseline to 16 weeks
The Eating Disorder Diagnostic Scale (EDDS) is a brief self-report measure that screens for the presence of subthreshold or threshold levels of ED symptoms. It yields a symptom composite score, to be used as the primary outcome measure. Items assessing body dissatisfaction, overvaluation of shape/weight, and impairment are measured on a 0 to 6-point scale with higher ratings indicating greater body dissatisfaction. Items evaluating the presence of compensatory behaviors and binge eating are rated yes/no and participants indicate the frequency these behaviors have occurred in the prior 3 months.
Change in global eating disorder symptoms
Time frame: Baseline to 16 weeks
The EDE-Q is a 28-item self-report version of the Eating Disorder Examination that measures frequency of disordered eating cognitions and behaviors experienced in the previous 28 days. Participants rate the number of days behaviors have occurred in the last 28 days, with 0 = no days and 6 = every day. Yes/no questions identify the presence of compensatory and binge behaviors and participants indicate the frequency of these behaviors over the last 28 days. Higher EDE-Q scores indicate greater eating pathology.
Changes in intuitive eating
Time frame: Baseline to 16 weeks
The Intuitive Eating Scale-2 (IES-2) is a 23-item self-report measure of intuitive eating with three subscales: Unconditional Permission to Eat, Eating for Physical Rather Than Emotional Reasons, and Reliance on Hunger and Satiety Cues. Items are rated on a 1 to 5-point scale with higher scores indicating higher levels of intuitive eating.
7 secondary outcomes
Change in body appreciation
Time frame: Baseline to 16 weeks
Changes in dietary restraint
Time frame: Baseline to 16 weeks
Changes in body functionality appreciation
Time frame: Baseline to 16 weeks
Changes in interoceptive awareness
Time frame: Baseline to 16 weeks
Changes in intuitive exercise
Time frame: Baseline to 16 weeks
Changes in weight bias internalization
Time frame: Baseline to 16 weeks
Changes in satisfaction with life
Time frame: Baseline to 16 weeks
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 13 Aug 2019.
- Individual participant dataSharing planned: No. IPD will be available by researcher request only after study completion. Interested researchers can email the primary study contact.
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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.
Suzanne Mazzeo, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Intervention and Guided Self-Help in people with Disordered Eating Behaviors, run by Virginia Commonwealth University 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 3 inclusion and 3 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 13 Aug 2019. 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?
Change in diagnostic eating disorder symptoms (time frame: Baseline to 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2019.