Prevention of weight gain in people who have had bariatric surgery Mental and Behavioural Disorders
Conditions
Interventions
Design
This will be a feasibility study for a single-centre, parallel group, single blind, two arm trial with participants randomised to either ACT or control. It will provide information about recru
however, should the rate of recruitment or follow-up be below that expected, the trialists will invite another local weight loss surgery service to participate. All elements of study participation wil
Sponsors
West London Mental Health NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults (aged 18 or over) who have undergone bariatric surgery >1 year ago and have given their consent for the study
Exclusion criteria
Exclusion criteria: 1. Suicidal ideation (score of > 0 on Question 9, PHQ-9) 2. Inability to communicate in English as the intervention is delivered in English 3. Inability to commit to attendance to 10 sessions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim of this study is to establish the feasibility of a definitive RCT of the effectiveness of ACT for preventing weight regain in post-bariatric surgery patients. Outcomes to be assessed are: 1. The willingness of participants to be randomised. This will be assessed using the number of eligible participants minus the number of patients who agree to randomisation (measured at screening) 2. The number of eligible patients coming through clinic. This will be assessed by calculating the percentage of patients who meet eligibility criteria (measured at baseline) 3. Recruitment and completion rates, follow-up rates, response rates to questionnaires, adherence/compliance rates to the intervention and trial procedures. This will be assessed by the number of participants who consent to participate and who remain in the study until 12 month follow-up, the number of participants who provide complete datasets, and the number of participants who attend all 10 sessions of intervention/support group. Reasons for attrition will also be recorded 4. Time needed to collect data. This will be assessed by how long it takes participants to complete the battery of questionnaires at each time point (measured at baseline, 3, 6 and 12 month follow-up) 5. The acceptability of the intervention to participants. This will be assessed by a visual analogue scale (measured at 12 month follow-up) 6. The standard deviation of potential outcome measures for a future trial (to estimate the required sample size for a future trial) (measured at study close-out) 7. Information to inform the undertaking of an economic evaluation in the definitive RCT and to pilot the data collection methods. This will be assessed by calculating the cost of the intervention and examining data on patients’ resource use on the CSRI (measured at study close-out) | — |
Secondary
| Measure | Time frame |
|---|---|
| The measures that will be evaluated within this feasibility study are as follows: MEASURES TO TEST THE PROCESS OF THE ACT INTERVENTION: 1. The ability to tolerate distress measured by the Distress Tolerance Scale at baseline, 3, 6, & 12 month follow-up 2. Present moment awareness and acceptance measured by the Philadelphia Mindfulness Scale at baseline, 3, 6 & 12 month follow-up 3. Experiential distancing measured by the Drexel Defusion Scale at baseline, 3, 6 & 12 month follow-up 4. The extent to which an individual is able to accept or tolerate physical or psychological discomfort, measured by the Physical Activity Acceptance Questionnaire at baseline, 3, 6 & 12 month follow-up 5. Acceptance of food related thoughts and urges measured by the Food Acceptance and Action Questionnaire at baseline, 3, 6 & 12 month follow-up OBESITY AND HEALTH OUTCOMES: 1. Class of obesity measured by the Kings Obesity Criteria at baseline and 12 month follow-up 2. Levels of physical activity measured by the International Physical Activity Questionnaire at baseline, 3, 6 & 12 month follow-up 3. Food intake measured by the Automated Self-Administered 24-hr Dietary Recall at baseline, 3, 6 & 12 month follow-up 4. Adherence to a Mediterranean diet measured by the Brief Mediterranean Diet Questionnaire at baseline, 3, 6 & 12 month follow-up 5. Level of risk to alcohol harm measured by the Alcohol Use Disorders Identification Test at baseline, 3, 6 & 12 month follow-up 6. Eating behaviour, in terms of restrained, emotional, and external eating, measured by the Dutch Eating Behaviour Questionnaire at baseline, 3, 6 & 12 month follow-up WELLBEING OUTCOMES: 1. Levels of anxiety and depression measured by the Hospital Anxiety and Depression Scale at baseline, 3, 6 & 12 month follow-up HEALTH ECONOMIC OUTCOMES: 1. Service utilisation, income, accommodation and other cost-related variables measured by the Client Service Receipt Inventory at baseline, 3, 6 & 12 month follow-up 2. Health-relate | — |
Countries
England, United Kingdom
Outcome results
None listed