Evaluation of the Implementation of PED-t in a Naturalistic Setting

NCT04980781 | Completed DMC

• 1 other identifier: 40503
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bulimia Nervosa; Binge-Eating Disorder

Keywords

remission; treatment; therapy; physical exercise; dietary therapy; diet; physical activity; naturalistic; Exercise referral centers; Healthy Living Centers; eating disorders; implementation

Outcome Measures

Primary Outcomes (6)

• 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)

  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)

  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)

  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)

  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)

  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)

  1 hour in December 2021, post-therapy

Secondary Outcomes (14)

• Therapy manual fidelity

  Once per 16 weeks (August-December)

• Rating of life quality before therapy

  Pre-therapy, week 0

• Rating of life quality after therapy

  Post-therapy, week 17

• Symptoms of depression before therapy

  Pre-therapy, week 0

• Symptoms of depression after therapy

  Post-therapy, week 17

Other Outcomes (17)

• Cardiorespiratory fitness (CRF) in patients before therapy

  Pre-therapy, week 0

• Cardiorespiratory fitness (CRF) in patients after therapy

  Post-therapy, week 17

• Resting metabolic rate (RMR) in patients before therapy

  Pre-therapy, week 0

Study Arms (2)

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).

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.

Procedure: Implementation program for PED-t in ERC

Interventions

Physical exercise and dietary therapy (PED-t) BEHAVIORAL

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.

Also known as: PED-t, FAKT

Participants receiving PED-t

Implementation program for PED-t in ERC PROCEDURE

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.

Therapists and management in ERC offering PED-t

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of bulimia nervosa or binge eating disorder
• BMI 17.5 - 40
• Women

You may not qualify if:

• Being/planning to become pregnant during the therapy period
• Competitive athlete
• Concurrent severe symptom- or personality disorder in need of other treatment options

Sponsors & Collaborators

• Ostfold University College: lead
• Norwegian School of Sport Sciences: collaborator
• University of Tromso: collaborator
• The Norwegian Women´s Public Health Association: collaborator
• Norwegian Council for Mental Health: collaborator
• The Dam Foundation: collaborator
• The Vibeke Skofterud Foundation: collaborator

Study Sites (1)

Fredrikstad Frisklivssentral (Exercise Referal Center in the municipality of Fredrikstad)

Fredrikstad, 1610, Norway

Location

Related Publications (1)

• 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.

  PMID: 28494809 BACKGROUND

MeSH Terms

Conditions

Bulimia Nervosa; Binge-Eating Disorder; Motor Activity; Feeding and Eating Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Therese F Mathisen, PhD

  Faculty of Health and Welfare, Østfold University College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking, as this is a non-controlled intervention trial.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: July 28, 2021
• Study Start: March 11, 2021
• Primary Completion: July 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)