Clinical trial NCT03075345: Acceptance and Commitment Therapy in the Treatment of Obesity: Pilot.
Official title: Testing the Added Benefit of Acceptance and Commitment Therapy (ACT) in the Treatment of Obesity: a Pilot Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity, Acceptance and Commitment Therapy, Weight Management Service
Lead sponsor: University of Sheffield
Sponsor class: OTHER
Collaborators: name: Mid Yorkshire Teaching NHS Trust
First posted: 2017-03-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity is an 'epidemic' within the UK. Individuals living with obseity are at risk of developing cancer, heart problems and dieing. Furthermore, obesity impacts on psychological wellbeing via lowered self-efficacy, self-esteem, body image and overall quality of life (QoL). A pilot randomised controlled trial (RCT) is proposed to investigate the additional benefit of a psychological intervention alongside treatment as usual (TAU) in a weight management service. Patients routinely attending an outpatient clinic will be randomised into TAU with or without additional acceptance and commitment Therapy (ACT) group based-input and their outcomes monitored over time.

Detailed description: Overweight and obesity is reported as an 'epidemic' problem within the UK as well as the world. Individuals living with this may be at higher risk of developing co-morbidities, such as cancers, heart problems or diabetes, and higher mortality rates are reported in this group. Furthermore, overweight and obesity can also impact on a person's psychological wellbeing, such as their self-efficacy, self-esteem and body image as well as have a negative effect on their overall quality of life (QoL). Therefore, a pilot randomised controlled trial (RCT) is proposed to investigate the additional benefit of a psychological intervention alongside treatment as usual (TAU) in a weight management service. Patients routinely attending an outpatient clinic will be randomised into TAU with or without additional Acceptance and Commitment Therapy (ACT) group based-input.

Eligibility criteria: Inclusion Criteria:

* Individuals will be willing and able to give informed consent for participation in the study;
* Male or Female, aged 18 years or above.
* Individuals will have a Body Mass Index (BMI) of over 40 (or over 35 if they are from a black or other minority ethic (BME) group or have a co-existing physical health problem);
* Individuals will be on a waiting list for a weight loss management programme in the UK;
* Individuals will have English as a written language.

Exclusion Criteria:

* Individuals who are currently pregnant or breastfeeding;
* Individuals with current drug or alcohol abuse, such that would prevent them from engaging in a weight management programme;
* Individuals who are acutely mentally unwell, such that would prevent them from engaging in a weight management programme;
* Individuals who at time of referral are at significant risk to themselves of others, such that would prevent them from engaging in a weight management programme;
* Individuals who are acutely physically unwell and/or hospitalised, such that would prevent them from engaging in a weight management programme;
* Individuals who have a learning disability or cognitive impairment, such that would prevent them from engaging in a weight management programme.
* Currently in receipt of psychiatric services.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 7 days
Secondary outcomes:
measure: Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
timeFrame: 24 hours
measure: Eating Self-Efficacy Scale (ESES)
timeFrame: 24 hours
measure: Action and Acceptance Questionnaire - II (AAQ-II)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: University of Sheffield
Study officials:
References: