Obesity, Acceptance and Commitment Therapy, Weight Management ServiceNCT03075345
Acceptance and Commitment Therapy in the Treatment of Obesity: Pilot.
A study testing Acceptance and commitment therapy and Treatment as usual (dietetic intervention) in people with Obesity, Acceptance and Commitment Therapy, Weight Management Service, run by University of Sheffield at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Acceptance and Commitment Therapy, Weight Management Service
- What is being tested?
- Acceptance and commitment therapy and Treatment as usual (dietetic intervention)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2017to Jan 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Added Benefit of Acceptance and Commitment Therapy (ACT) in the Treatment of Obesity: a Pilot Randomised Controlled Trial.
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.
Read the 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.
- Being tested
- Acceptance and commitment therapy, Treatment as usual (dietetic intervention)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and commitment therapyBehavioural
Four sessions of the ACT protocol will be psychoeducational in nature, with brief experiential exercises in the class and in-between session practice. It's aim is to allow individuals to be able to sit with difficult experiences (rather than fight against them) and in turn this may allow them to live towards what they value in life.
Treatment as usual (dietetic intervention)Behavioural
Six sessions of a dietetic intervention will be psychoeducational in nature around weight and nutrition, delivered by professionals working in the service.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual (weight management intervention) | Active comparator | 6 session weight management programme (over 12 weeks). Receives: Behavioral: Treatment as usual (dietetic intervention) |
| Treatment as usual plus acceptance and commitment therapy | Experimental | 6 session weight management programme (over 12 weeks) plus a 4 session acceptance and commitment therapy (ACT) programme. The ACT part will commence straight after the conclusion of the weight management programme. Receives: Behavioral: Acceptance and commitment therapy; Behavioral: Treatment as usual (dietetic intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale (HADS)
A measure of psychological distress in relation to anxiety and depression symptoms. There is a total of 14 items (7 items relate to anxiety; 7 items relate to depression) with answers scored on a Likert scale of 0-3 (scores from 0-42; higher scores indicating worse symptoms).
Measured: 7 days
Secondary outcomes (3)
Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
The SF-36 is a generic measure of health related quality of life. There is a total of 36 questions which can be grouped into 3 levels: i) 36 individual items; ii) 8 subscales; iii) 2 summary measures.
Measured: 24 hours
Eating Self-Efficacy Scale (ESES)
It measures self-efficacy. It contains 25-items measuring the person's confidence in ability to manage overeating in various situations (Likert scale 1-7 used).
Measured: 24 hours
Action and Acceptance Questionnaire - II (AAQ-II)
The AAQ-II is a measure of experiential avoidance (i.e., attempts to alter difficult internal experiences which often leads to increased distress) and psychological inflexibility. Patients are asked to rate their experiences on a 7-point Likert scale (from '1: never true' to '7: always true').
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study startMay 2017 (estimated)
- Primary completionOct 2017 (estimated)
- Study completionJan 2018 (estimated)
Why it stopped: NHS service understaffing which made study unable to begin.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, Acceptance and Commitment Therapy, Weight Management ServiceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Collaborators
- Mid Yorkshire Teaching NHS Trust
- Responsible party
- Principal investigator, Sarah Wakefield, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075345
- Sponsor's protocol ID
- 151261
- Status last verified
- Oct 2018
- First submitted
- 4 Mar 2017
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Added Benefit of Acceptance and Commitment Therapy (ACT) in the Treatment of Obesity: a Pilot Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT03075345
- Acronym / sponsor ID
- 151261
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: NHS service understaffing which made study unable to begin.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Collaborators
- Mid Yorkshire Teaching NHS Trust
- Study start
- May 2017 (estimated)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 9 Mar 2017 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual (weight management intervention) | Active comparator | Behavioral: Treatment as usual (dietetic intervention)6 session weight management programme (over 12 weeks). |
| Treatment as usual plus acceptance and commitment therapy | Experimental | Behavioral: Acceptance and commitment therapy, Behavioral: Treatment as usual (dietetic intervention)6 session weight management programme (over 12 weeks) plus a 4 session acceptance and commitment therapy (ACT) programme. The ACT part will commence straight after the conclusion of the weight management programme. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
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 |
|---|---|---|
| Acceptance and commitment therapyFour sessions of the ACT protocol will be psychoeducational in nature, with brief experiential exercises in the class and in-between session practice. It's aim is to allow individuals to be able to sit with difficult experiences (rather than fight against them) and in turn this may allow them to live towards what they value in life. | Behavioural | Treatment as usual plus acceptance and commitment therapy |
| Treatment as usual (dietetic intervention)Six sessions of a dietetic intervention will be psychoeducational in nature around weight and nutrition, delivered by professionals working in the service. | Behavioural | Treatment as usual (weight management intervention), Treatment as usual plus acceptance and commitment therapy |
Primary outcome
Hospital Anxiety and Depression Scale (HADS)
Time frame: 7 days
A measure of psychological distress in relation to anxiety and depression symptoms. There is a total of 14 items (7 items relate to anxiety; 7 items relate to depression) with answers scored on a Likert scale of 0-3 (scores from 0-42; higher scores indicating worse symptoms).
3 secondary outcomes
Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
Time frame: 24 hours
Eating Self-Efficacy Scale (ESES)
Time frame: 24 hours
Action and Acceptance Questionnaire - II (AAQ-II)
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: No
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 Acceptance and commitment therapy and Treatment as usual (dietetic intervention) in people with Obesity, Acceptance and Commitment Therapy, Weight Management Service, run by University of Sheffield at 1 site in United Kingdom.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 16 Oct 2018. 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 Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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?
Hospital Anxiety and Depression Scale (HADS) (time frame: 7 days). 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 16 Oct 2018; AzTrials last refreshed its copy on 6 Nov 2026.