Bulimia NervosaEVA-PEDtNCT04980781
Evaluation of the Implementation of PED-t in a Naturalistic Setting
A study testing Physical exercise and dietary therapy (PED-t) and Implementation program for PED-t in ERC in people with Bulimia Nervosa and Binge-Eating Disorder, run by Ostfold University College at 1 site in Norway.
Trial summary
The Eva-PED-t project will evaluate implementation of a new therapy for eating disorders, called PED-t (Physical Exercise and Dietary therapy), in a new treatment arena for such illnesses. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Bulimia Nervosa, Binge-Eating Disorder
- What is being tested?
- Physical exercise and dietary therapy (PED-t) and Implementation program for PED-t in ERC
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNorway
- Study dates
- 11 Mar 2021to 31 Dec 2022
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of bulimia nervosa or binge eating disorder
- BMI 17.5 - 40
- Women
Who cannot join
- Being/planning to become pregnant during the therapy period
- Competitive athlete
- Concurrent severe symptom- or personality disorder in need of other treatment options
Trial locations and contacts
1 site in 1 country.
Norway1 site
Fredrikstad Frisklivssentral (Exercise Referal Center in the municipality of Fredrikstad)
Fredrikstad, 1610
About this study
Official title: Evaluation of the Implementation of a New Therapy for Bulimia Nervosa and Binge Eating Disorder; Physical Exercise and Dietary Therapy (PED-t), in a Naturalistic Setting
The Eva-PED-t project will evaluate implementation of a new therapy for eating disorders, called PED-t (Physical Exercise and Dietary therapy), in a new treatment arena for such illnesses. By this, Eva-PED-t evaluates effectiveness- and efficacy outcomes, with the latter highlighting both the user-, the therapists- and the management perspectives. The research group behind this initiative comprises the founders of the PED-t, and holds extensive expertise on research methodology, eating disorders, health science, and exercise medicine, affiliated high-ranked research-intensive universities. Previous documentation of poor implementation of evidence-based knowledge in public health services reveal poor or no translation of new research findings for improved screening, treatment or medical procedures into real life settings. This may impair public health service outcomes, as less effective or ineffective treatment or procedures are routinely preferred. In a randomized controlled trial, the Eva-PED-t partnership recently found a new therapy for eating disorders (PED-t) to be comparable effective to the currently recommended treatment (NCT02079935). Specific advantages with PED-t, are the use of professionals not currently used in therapy of mental disorders, and the efficiency of arranging therapy in groups, hence effectively dealing with the high request for therapy. The Eva PED-t collaborative is motivated by the knowledge of high prevalence of mental illnesses, for which there is a need to improve treatment access and -efficiency. Adding to this scenario, is the new and more prevalent diagnosis of eating disorders, binge eating disorder, for which specialized health services have no prioritization for treatment. Addressing requirements for improved therapy access demands investigation of new treatments and new ways of delivery. The PED-t responds to this request, still recommendation for a broad implementation necessitate exploration of implementation strategies and experiences.
Read the detailed description
Implementation research intends to identify facilitating and obstructing elements in the process of transferring evidence-based practices from controlled settings to naturalistic settings. Unfortunately, the implementation of evidence-based knowledge is challenged by lack of institutional resources and insufficient prioritization by the management, and lack of prioritization by funders and academic researchers. As such, a lag time before evidence-based knowledge from research is translated in to real world practice is typically estimated to be about 14-20 years. The delay in implementation of evidence-based practice is found to be specifically relevant in health care services, hence, ultimately depriving patients from best practice. Exercise referral centers (ERC, also known as Healthy Living Centers) are part of the municipally public health care, providing support for improved healthy living behavior. Service users are confident by the professional skills in the ERC, and trust the service to be evidence-based. However, there are a wide variety in program approaches and methodology, most with no evidence-based foundation, and a lack of documentation on effects. Hence originally, the UK National Institute for Health and Clinical Excellence (NICE) recommended not to commission ERC in primary health care other than in well-designed research studies. The ERC's are in an early progress, still exploring their role in public health care and having stakeholders requesting evidence-based methods, and as such, identification of successful interventions at the ERC's is necessitated.
The Eva-PED-t has the potential to pick up on the shortfalls in documentation of effectiveness outcomes and exploration of efficacy of evidence-based interventions at the ERC's, and the poor implementation of evidence-based treatment in public health services in general. The EVA_PED intend to evaluate the implementation of the PED-t in the public health care services ERC in terms of effectiveness and efficacy, and by a mixed methods design. By relying on the original team behind the development of the PED-t to train the therapists, inform and supervise the management, and to provide support during implementation, this project has the potential to ease the implementation process. As such, the EVA-PED aim to follow the request to evaluate the total implementation success (i.e. the sum of the effectiveness of treatment and the experiences of implementation within the organization).
The researchers behind the EVA-PED finalized the evaluation of effectivity from PED-t on treatment of eating disorders in 2018 (NCT02079935), bringing optimism on increased therapy access, lowering barriers for treatment seeking behavior, and facilitating a more effective treatment delivery. Having the PED-t research team initiating Eva-PED-t, this project will bypass the delay in translation of evidence-based knowledge to real life settings. The Eva-PED-t has the potential to identify any elements undermining optimal uptake of this evidence-based treatment in public health services. Informed on previous challenges on successful implementation of evidence-based procedures, Eva-PED-t grasp on these most critical elements. Providing practical training and adequate time for preparations, mentoring during therapy operation, relying on therapy elements similar to what the therapists have practiced in their regular work, and by communicating, involving and motivating several levels in the organizations (management and therapists); the EVA_PED target the most critical elements previously found to impair successful implementation. Additionally, by involving former patients and therapists from the PED-t intervention as user groups, combined with the findings from in depth interviews in the corresponding groups of patients and therapists, the EVA-PED will evaluate adjustments of the therapy and arrangement according to their experiences and advices.
The EVA-PED-t project aims to evaluate the success of adopting and operating the evidence-based PED-t in naturalistic settings like ERC's, physiotherapy clinics and multidisciplinary medical centers. By this, the project intends to study effectiveness outcomes and efficacy outcomes, with the latter highlighting both the user perspectives, the therapists- and the management perspectives. A part of the efficacy outcomes, is evaluation on the treatment fidelity by individual therapists.
This generate the following main- and secondary research questions (RQ):
Main RQ:
- Which elements promotes or discourages the implementation of PED-t according to; a) the therapists, and b) the management at the therapy cites?
Secondary RQ's:
- How well is the implementation quality concerning treatment fidelity in a naturalistic setting?
- What are the experiences amongst the patients receiving PED-t in a naturalistic setting?
- How effective is the PED-t in a naturalistic setting, evaluated in remission from diagnosis, in rating of quality of life, in intensity of symptoms for depression, anxiety and symptoms of an eating disorder, and in changes of eating- and exercise behavior?
- Conditions
- Bulimia Nervosa, Binge-Eating Disorder
- Being tested
- Physical exercise and dietary therapy (PED-t), Implementation program for PED-t in ERC
- Keywords
- remission, treatment, therapy, physical exercise, dietary therapy, diet, physical activity, naturalistic, Exercise referral centers, Healthy Living Centers, eating disorders, implementation
- Medical subject headings
- Bulimia Nervosa, Binge-Eating Disorder, Motor Activity, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise and dietary therapy (PED-t)Behavioural
Also called PED-t, FAKT
Behavioral therapy: Physical exercise and dietary therapy (PED-t) is a treatment of bulimia nervosa and binge eating disorder, relying on guided, progressive resistance exercise therapy and dietary therapy (dietary education and group discussions) following a designed therapy manual.
Implementation program for PED-t in ERCProcedure or surgery
Participating in a training program for therapists in PED-t; to increase knowledge of eating disorders and to be able to implement and run the PED-t. Training program consists of a therapy manual, digital lectures, and 3 work shops.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving PED-t | Experimental | Participants, i.e. females with bulimia nervosa or binge eating disorder, are recruited for therapy in the trained ERC. The treatment program consists of 20 behavioral therapy sessions covering 16 weeks, and with single follow-up sessions at 2-, and 4- months post-therapy.
Participants are interviewed on the expectations to- and experiences from having therapy in the ECR, and monitored and evaluated on therapy effectiveness (i.e. diagnostic outcomes). Receives: Behavioral: Physical exercise and dietary therapy (PED-t) |
| Therapists and management in ERC offering PED-t | Experimental | Employees in the ECR and the management will be trained in giving PED-t in their facility, and will then perform therapy with a single group of participants recruited.
Therapists/employees trained in PED-t will be interviewed about their expectations to- and experiences from giving the PED-t, and also being monitored according to therapy manual fidelity.
The management at the facility offering PED-t will be interviewed about their experiences on administration and implementation of the PED-t in their facility. Receives: Procedure: Implementation program for PED-t in ERC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expectations and readiness for running the PED-t (therapists)
After training for PED-t; what are the therapists expectations to offering the PED-t and how able and ready do they feel about taking care of the patients? (semistructured interviews)
Measured: 1 hour in June 2021, pre-therapy
Experiences after running the PED-t (therapists)
After running the PED-t; what are the therapists experiences from offering the PED-t and (semistructured interviews)
Measured: 1 hour in December 2021, post-therapy
Expectations on receiving PED-t in the ERC (patients)
What are the patients expectations to receive PED-t in in the ERC? (semistructured interviews)
Measured: 1 hour in August 2021, pre-therapy
Experiences from receiving PED-t in the ERC (patients)
What are the patients experiences from receiving PED-t in in the ERC? (semistructured interviews)
Measured: 1 hour in December 2021, post-therapy
Management of training program and therapy in the ERC (leaders in the ERC)
What are the leaders experiences on managing therapy training for employees, and expectations to offer a new therapy in the local ERC? (semistructured interviews)
Measured: 1 hour in August 2021, pre-therapy
Management/implementation of PED-t in the ERC (leaders in the ERC)
What are the leaders experiences on managing/implementing the PED-t in the local ERC? (semistructured interviews)
Measured: 1 hour in December 2021, post-therapy
Secondary outcomes (14)
Therapy manual fidelity
Electronic questionnaire measuring therapy manual fidelity, distributed on a weekly basis. Responding yes/no to whether specific topics has been addressed.
Measured: Once per 16 weeks (August-December)
Rating of life quality before therapy
QoL measured with the Satisfaction with life scale. This is a short 5-item scale measuring overall contentment with life compared to personal standards and expectations, using a 5-point Likert scale ranging from1 (never true) to 7 (always true) (Diener, 1994)
Measured: Pre-therapy, week 0
Rating of life quality after therapy
QoL measured with the Satisfaction with life scale. This is a short 5-item scale measuring overall contentment with life compared to personal standards and expectations, using a 5-point Likert scale ranging from1 (never true) to 7 (always true) (Diener, 1994)
Measured: Post-therapy, week 17
Symptoms of depression before therapy
Measured with the Beck Depression Inventory. Consists of 22 items rated from 0 to 3, resulting in a total score up to 65 points, and where scoring of 21 or above indicates having symptoms of depression.
Measured: Pre-therapy, week 0
Symptoms of depression after therapy
Measured with the Beck Depression Inventory. Consists of 22 items rated from 0 to 3 (one item scores 0-1), resulting in a total score up to 64 points, in which higher scoring means higher severity, and where scoring of 21 or above indicates having symptoms of depression.
Measured: Post-therapy, week 17
Symptoms of anxiety before therapy
Measured with the Beck Anxiety Inventory. Consists of 21 items, scored from 0-3, with higher scoring indicating higher severity.
Measured: Pre-therapy, week 0
Symptoms of anxiety after therapy
Measured with the Beck Anxiety Inventory. Consists of 21 items, scored from 0-3, with higher scoring indicating higher severity.
Measured: Post-therapy, week 17
Symptoms of compulsive exercise before therapy
Measured with the Compulsive exercise test. CET is a 24-item instrument scored on a 5-point Likert scale (0 = never true, 5 = always true), and evaluated with five different subscale mean scores.
Measured: Pre-therapy, week 0
Symptoms of compulsive exercise after therapy
Measured with the Compulsive exercise test. CET is a 24-item instrument scored on a 5-point Likert scale (0 = never true, 5 = always true), and evaluated with five different subscale mean scores.
Measured: Post-therapy, week 17
Symptoms of eating disorder before therapy
Evaluated by the Eating Disorder Examination questionnaire. Consists of 28 items, for which 22 items are rated from 0-6, and 6 items consists of selfreported number of binge-eating or purging episodes. Higher items scorings means higher severity, a total score above 2.5 indicates a diagnosis of eating disorder (according to validation in a Norwegian sample), and diagnosis necessitates at least 1 episode of binge-eating and/or purging per week.
Measured: Pre-therapy, week 0
Symptoms of eating disorder after therapy
Evaluated by the Eating Disorder Examination questionnaire. Consists of 28 items, for which 22 items are rated from 0-6, and 6 items consists of selfreported number of binge-eating or purging episodes. Higher items scorings means higher severity, a total score above 2.5 indicates a diagnosis of eating disorder (according to validation in a Norwegian sample), and diagnosis necessitates at least 1 episode of binge-eating and/or purging per week.
Measured: Post-therapy, week 17
Evaluation of an eating disorder diagnosis
Evaluation on diagnosis by the Eating Disorder Examination questionnaire (EDE-q) and clinical interview to manually affirm symptoms reported in EDE-q.
Measured: Pre-therapy, week 0
How effective is the PED-t in a naturalistic setting, evaluated in remission from diagnosis?
Evaluation on diagnosis by the Eating Disorder Examination questionnaire (EDE-q) and clinical interview to manually affirm symptoms reported in EDE-q.
Measured: Post-therapy, week 17
Symptoms of eating disorder behavior
Selfreported number of binge-eating episodes and purging episodes per week.
Measured: Once per week during 16 weeks of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start11 Mar 2021
- Primary completion31 Jul 2022
- Study completion31 Dec 2022
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 Bulimia NervosaStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Employees and management in a ECR receive training in PED-t, and successively arrange the therapy. Experiences with the program training, and expectations to and experiences from giving the therapy, are the main research questions. Managements will be interviewed according to experiences with management of- and suitability of the therapy in the ECR Eligible participants with bulimia nervosa or binge eating disorder are recruited for therapy in the ECR. Their expectations to- and experiences from having therapy in the ECR are the main research questions, in addition to evaluation of therapy success. A previous RCT has evaluated the treatment efficiency by comparing it to a control group and another standardized treatment intervention. As such, the main focus of the current study is to evaluate experiences from arranging PED-t in a naturalistic setting, and secondly to evaluate if treatment efficiency can be replicated.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold University College
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, University of Tromso, The Norwegian Women´s Public Health Association, Norwegian Council for Mental Health, The Dam Foundation, The Vibeke Skofterud Foundation
- Responsible party
- Principal investigator, Therese Fostervold Mathisen, Ostfold University College
- Investigators
- Therese F Mathisen, PhD, Principal investigator, Faculty of Health and Welfare, Østfold University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980781
- Sponsor's protocol ID
- 40503
- Acronym
- EVA-PEDt
- Status last verified
- Mar 2023
- First submitted
- 22 Mar 2021
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is reserved the research group
Publications
Mathisen TF, Rosenvinge JH, Pettersen G, Friborg O, Vrabel K, Bratland-Sanda S, Svendsen M, Stensrud T, Bakland M, Wynn R, Sundgot-Borgen J. The PED-t trial protocol: The effect of physical exercise -and dietary therapy compared with cognitive behavior therapy in treatment of bulimia nervosa and binge eating disorder. BMC Psychiatry. 2017 May 12;17(1):180. doi: 10.1186/s12888-017-1312-4.
PubMed 28494809Mathisen TF, Pettersen G, Rosenvinge JH, Schmidt U, Sundgot-Borgen J. Effectiveness and acceptability of the physical exercise and dietary therapy in a healthy life center. Int J Eat Disord. 2023 Oct;56(10):1931-1940. doi: 10.1002/eat.24020. Epub 2023 Jul 17.
PubMed 37458357
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Implementation of a New Therapy for Bulimia Nervosa and Binge Eating Disorder; Physical Exercise and Dietary Therapy (PED-t), in a Naturalistic Setting
- ClinicalTrials.gov ID
- NCT04980781
- Acronym / sponsor ID
- EVA-PEDt / 40503
- Conditions
- Bulimia Nervosa, Binge-Eating Disorder
- Keywords
- remission, treatment, therapy, physical exercise, dietary therapy, diet, physical activity, naturalistic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ostfold University CollegeUniversity, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, University of Tromso, The Norwegian Women´s Public Health Association, Norwegian Council for Mental Health, The Dam Foundation, The Vibeke Skofterud Foundation
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 28 Jul 2021 (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 Eva-PED-t project will evaluate implementation of a new therapy for eating disorders, called PED-t (Physical Exercise and Dietary therapy), in a new treatment arena for such illnesses. By this, Eva-PED-t evaluates effectiveness- and efficacy outcomes, with the latter highlighting both the user-, the therapists- and the management perspectives. The research group behind this initiative comprises the founders of the PED-t, and holds extensive expertise on research methodology, eating disorders, health science, and exercise medicine, affiliated high-ranked research-intensive universities. Previous documentation of poor implementation of evidence-based knowledge in public health services reveal poor or no translation of new research findings for improved screening, treatment or medical procedures into real life settings. This may impair public health service outcomes, as less effective or ineffective treatment or procedures are routinely preferred. In a randomized controlled trial, the Eva-PED-t partnership recently found a new therapy for eating disorders (PED-t) to be comparable effective to the currently recommended treatment (NCT02079935). Specific advantages with PED-t, are the use of professionals not currently used in therapy of mental disorders, and the efficiency of arranging therapy in groups, hence effectively dealing with the high request for therapy. The Eva PED-t collaborative is motivated by the knowledge of high prevalence of mental illnesses, for which there is a need to improve treatment access and -efficiency. Adding to this scenario, is the new and more prevalent diagnosis of eating disorders, binge eating disorder, for which specialized health services have no prioritization for treatment. Addressing requirements for improved therapy access demands investigation of new treatments and new ways of delivery. The PED-t responds to this request, still recommendation for a broad implementation necessitate exploration of implementation strategies and experiences.
Detailed description
Implementation research intends to identify facilitating and obstructing elements in the process of transferring evidence-based practices from controlled settings to naturalistic settings. Unfortunately, the implementation of evidence-based knowledge is challenged by lack of institutional resources and insufficient prioritization by the management, and lack of prioritization by funders and academic researchers. As such, a lag time before evidence-based knowledge from research is translated in to real world practice is typically estimated to be about 14-20 years. The delay in implementation of evidence-based practice is found to be specifically relevant in health care services, hence, ultimately depriving patients from best practice. Exercise referral centers (ERC, also known as Healthy Living Centers) are part of the municipally public health care, providing support for improved healthy living behavior. Service users are confident by the professional skills in the ERC, and trust the service to be evidence-based. However, there are a wide variety in program approaches and methodology, most with no evidence-based foundation, and a lack of documentation on effects. Hence originally, the UK National Institute for Health and Clinical Excellence (NICE) recommended not to commission ERC in primary health care other than in well-designed research studies. The ERC's are in an early progress, still exploring their role in public health care and having stakeholders requesting evidence-based methods, and as such, identification of successful interventions at the ERC's is necessitated.
The Eva-PED-t has the potential to pick up on the shortfalls in documentation of effectiveness outcomes and exploration of efficacy of evidence-based interventions at the ERC's, and the poor implementation of evidence-based treatment in public health services in general. The EVA_PED intend to evaluate the implementation of the PED-t in the public health care services ERC in terms of effectiveness and efficacy, and by a mixed methods design. By relying on the original team behind the development of the PED-t to train the therapists, inform and supervise the management, and to provide support during implementation, this project has the potential to ease the implementation process. As such, the EVA-PED aim to follow the request to evaluate the total implementation success (i.e. the sum of the effectiveness of treatment and the experiences of implementation within the organization).
The researchers behind the EVA-PED finalized the evaluation of effectivity from PED-t on treatment of eating disorders in 2018 (NCT02079935), bringing optimism on increased therapy access, lowering barriers for treatment seeking behavior, and facilitating a more effective treatment delivery. Having the PED-t research team initiating Eva-PED-t, this project will bypass the delay in translation of evidence-based knowledge to real life settings. The Eva-PED-t has the potential to identify any elements undermining optimal uptake of this evidence-based treatment in public health services. Informed on previous challenges on successful implementation of evidence-based procedures, Eva-PED-t grasp on these most critical elements. Providing practical training and adequate time for preparations, mentoring during therapy operation, relying on therapy elements similar to what the therapists have practiced in their regular work, and by communicating, involving and motivating several levels in the organizations (management and therapists); the EVA_PED target the most critical elements previously found to impair successful implementation. Additionally, by involving former patients and therapists from the PED-t intervention as user groups, combined with the findings from in depth interviews in the corresponding groups of patients and therapists, the EVA-PED will evaluate adjustments of the therapy and arrangement according to their experiences and advices.
The EVA-PED-t project aims to evaluate the success of adopting and operating the evidence-based PED-t in naturalistic settings like ERC's, physiotherapy clinics and multidisciplinary medical centers. By this, the project intends to study effectiveness outcomes and efficacy outcomes, with the latter highlighting both the user perspectives, the therapists- and the management perspectives. A part of the efficacy outcomes, is evaluation on the treatment fidelity by individual therapists.
This generate the following main- and secondary research questions (RQ):
Main RQ:
- Which elements promotes or discourages the implementation of PED-t according to; a) the therapists, and b) the management at the therapy cites?
Secondary RQ's:
- How well is the implementation quality concerning treatment fidelity in a naturalistic setting?
- What are the experiences amongst the patients receiving PED-t in a naturalistic setting?
- How effective is the PED-t in a naturalistic setting, evaluated in remission from diagnosis, in rating of quality of life, in intensity of symptoms for depression, anxiety and symptoms of an eating disorder, and in changes of eating- and exercise behavior?
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Employees and management in a ECR receive training in PED-t, and successively arrange the therapy. Experiences with the program training, and expectations to and experiences from giving the therapy, are the main research questions. Managements will be interviewed according to experiences with management of- and suitability of the therapy in the ECR Eligible participants with bulimia nervosa or binge eating disorder are recruited for therapy in the ECR. Their expectations to- and experiences from having therapy in the ECR are the main research questions, in addition to evaluation of therapy success. A previous RCT has evaluated the treatment efficiency by comparing it to a control group and another standardized treatment intervention. As such, the main focus of the current study is to evaluate experiences from arranging PED-t in a naturalistic setting, and secondly to evaluate if treatment efficiency can be replicated.
| Arm | Type | Receives |
|---|---|---|
| Participants receiving PED-t | Experimental | Behavioral: Physical exercise and dietary therapy (PED-t)Participants, i.e. females with bulimia nervosa or binge eating disorder, are recruited for therapy in the trained ERC. The treatment program consists of 20 behavioral therapy sessions covering 16 weeks, and with single follow-up sessions at 2-, and 4- months post-therapy. Participants are interviewed on the expectations to- and experiences from having therapy in the ECR, and monitored and evaluated on therapy effectiveness (i.e. diagnostic outcomes). |
| Therapists and management in ERC offering PED-t | Experimental | Procedure: Implementation program for PED-t in ERCEmployees in the ECR and the management will be trained in giving PED-t in their facility, and will then perform therapy with a single group of participants recruited. Therapists/employees trained in PED-t will be interviewed about their expectations to- and experiences from giving the PED-t, and also being monitored according to therapy manual fidelity. The management at the facility offering PED-t will be interviewed about their experiences on administration and implementation of the PED-t in their facility. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of bulimia nervosa or binge eating disorder
- BMI 17.5 - 40
- Women
Key exclusion criteria (3 listed)
- Being/planning to become pregnant during the therapy period
- Competitive athlete
- Concurrent severe symptom- or personality disorder in need of other treatment options
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 |
|---|---|---|
| Physical exercise and dietary therapy (PED-t)Also: PED-t, FAKTBehavioral therapy: Physical exercise and dietary therapy (PED-t) is a treatment of bulimia nervosa and binge eating disorder, relying on guided, progressive resistance exercise therapy and dietary therapy (dietary education and group discussions) following a designed therapy manual. | Behavioural | Participants receiving PED-t |
| Implementation program for PED-t in ERCParticipating in a training program for therapists in PED-t; to increase knowledge of eating disorders and to be able to implement and run the PED-t. Training program consists of a therapy manual, digital lectures, and 3 work shops. | Procedure or surgery | Therapists and management in ERC offering PED-t |
Primary outcome
Expectations and readiness for running the PED-t (therapists)
Time frame: 1 hour in June 2021, pre-therapy
After training for PED-t; what are the therapists expectations to offering the PED-t and how able and ready do they feel about taking care of the patients? (semistructured interviews)
Experiences after running the PED-t (therapists)
Time frame: 1 hour in December 2021, post-therapy
After running the PED-t; what are the therapists experiences from offering the PED-t and (semistructured interviews)
Expectations on receiving PED-t in the ERC (patients)
Time frame: 1 hour in August 2021, pre-therapy
What are the patients expectations to receive PED-t in in the ERC? (semistructured interviews)
Experiences from receiving PED-t in the ERC (patients)
Time frame: 1 hour in December 2021, post-therapy
What are the patients experiences from receiving PED-t in in the ERC? (semistructured interviews)
Management of training program and therapy in the ERC (leaders in the ERC)
Time frame: 1 hour in August 2021, pre-therapy
What are the leaders experiences on managing therapy training for employees, and expectations to offer a new therapy in the local ERC? (semistructured interviews)
Management/implementation of PED-t in the ERC (leaders in the ERC)
Time frame: 1 hour in December 2021, post-therapy
What are the leaders experiences on managing/implementing the PED-t in the local ERC? (semistructured interviews)
14 secondary outcomes
Therapy manual fidelity
Time frame: Once per 16 weeks (August-December)
Rating of life quality before therapy
Time frame: Pre-therapy, week 0
Rating of life quality after therapy
Time frame: Post-therapy, week 17
Symptoms of depression before therapy
Time frame: Pre-therapy, week 0
Symptoms of depression after therapy
Time frame: Post-therapy, week 17
Symptoms of anxiety before therapy
Time frame: Pre-therapy, week 0
Symptoms of anxiety after therapy
Time frame: Post-therapy, week 17
Symptoms of compulsive exercise before therapy
Time frame: Pre-therapy, week 0
Symptoms of compulsive exercise after therapy
Time frame: Post-therapy, week 17
Symptoms of eating disorder before therapy
Time frame: Pre-therapy, week 0
Symptoms of eating disorder after therapy
Time frame: Post-therapy, week 17
Evaluation of an eating disorder diagnosis
Time frame: Pre-therapy, week 0
How effective is the PED-t in a naturalistic setting, evaluated in remission from diagnosis?
Time frame: Post-therapy, week 17
Symptoms of eating disorder behavior
Time frame: Once per week during 16 weeks of therapy
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 22 Mar 2023.
- Background: PubMed 28494809Mathisen TF, Rosenvinge JH, Pettersen G, Friborg O, Vrabel K, Bratland-Sanda S, Svendsen M, Stensrud T, Bakland M, Wynn R, Sundgot-Borgen J. The PED-t trial protocol: The effect of physical exercise -and dietary therapy compared with cognitive behavior therapy in treatment of bulimia nervosa and binge eating disorder. BMC Psychiatry. 2017 May 12;17(1):180. doi: 10.1186/s12888-017-1312-4.
- Derived from this study: PubMed 37458357Mathisen TF, Pettersen G, Rosenvinge JH, Schmidt U, Sundgot-Borgen J. Effectiveness and acceptability of the physical exercise and dietary therapy in a healthy life center. Int J Eat Disord. 2023 Oct;56(10):1931-1940. doi: 10.1002/eat.24020. Epub 2023 Jul 17.
- Individual participant dataSharing planned: No. Data is reserved the research group
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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.
Therese F Mathisen, PhD principal investigator
Faculty of Health and Welfare, Østfold University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise and dietary therapy (PED-t) and Implementation program for PED-t in ERC in people with Bulimia Nervosa and Binge-Eating Disorder, run by Ostfold University College at 1 site in Norway.
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 22 Mar 2023. 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 Norway. 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?
Expectations and readiness for running the PED-t (therapists) (time frame: 1 hour in June 2021, pre-therapy). The study lists 6 primary outcomes in all. 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 NCT04980781, 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 22 Mar 2023.