Obesity
Conditions
Keywords
Obesity, Tier 3, weight-loss
Brief summary
Over one in four adults living in the UK is living with obesity. Obesity is associated with health complications including type 2 diabetes, heart disease and depression. The current NHS treatment for obesity includes attending a specialist hospital weight management service called 'Tier 3' where patients receive help from healthcare professionals such as doctors, dieticians and psychologists. It is known that health conditions associated with obesity improve or reverse if a person with obesity loses five per cent or more of their body weight. On average, currently available Tier 3 programmes achieve less weight loss than this. In our specialist obesity clinic at the Imperial Weight Centre, we (the study research team) have designed a new weight loss programme called Imperial Satiety Protocol (or I-SatPro for short). I-SatPro comprises dietary advice including eating a low carbohydrate (low glycaemic index) diet, eating protein for the satiating effects, eating healthy fats and abstaining from high sugar and/or processed foods which can drive over-eating. Participants will be advised to eat according to subjective feelings of hunger and fullness, rather than eating according to a defined calorie restriction. Similar to other Tier 3 Programmes, I-SatPro also contains locally devised content related to healthy eating, for example fibre intake, the timing of eating, lifestyle change such as exercise, self-care such as advice on sleep and behavioural change strategies.
Detailed description
The purpose of this feasibility/pilot study is to check whether: 1. Our patients like I-SatPro 2. Whether our patients want to follow I-SatPro 3. Check whether our patients following I-SatPro achieve improvements in their health including: weight loss, changes in blood pressure, changes in diabetes control, changes in blood lipids 'cholesterol', changes in their eating patterns and relationship with food, changes in their wellbeing
Interventions
OTHERI-SatPro weight loss programme
I-SatPro weight loss programme: participants advised on I-SatPro dietary change as well as eating patterns, lifestyle change such as exercise, self-care such as advice on sleep and behavioural change strategies.
OTHERTier 3 weight loss programme
Tier 3 weight loss programme: participants advised to make changes to food choices in accordance with NHS healthy eating advice, eating habits, lifestyle change such as exercise, mindful eating and behavioural change strategies.
Sponsors
Imperial College Healthcare NHS Trust
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two groups of patients will be recruited from our hospital obesity clinic. One group will take part in the I-SatPro weight management programme One group will take part in the Tier 3 weight loss programme that is currently offered in our clinical service.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥18 years * Male or female * Body mass index ≥35kg/m2 with at least one obesity related co-morbidity * Body mass index ≥40kg/m2 with or without an obesity related co-morbidity * Eligible for treatment under the NHS
Exclusion criteria
* History of any medical, psychological or other condition, or use of any medications, which would either compromise the validity of the study or the safety of the participant * English language fluency and comprehension insufficient to be able to participate in educational and group components of the programme * Usual residence/place of work is sufficiently far from the study site or logistical/lifestyle factors mean that it is likely that the patient would be unable to attend for all sessions/components of the study * Pregnancy or breast feeding * Previous bariatric surgery * Concurrent participation in another research study which would either compromise the validity of the study or the safety of the participant * Previous participation in a study if the investigators judge that this would either compromise the validity of the study or the safety of the participant * Unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight Change | First patient group visit (week 0) to end of study (week 52) | Change in body weight will be measured from patient group session 1 (week 0) to the end of study (week 52) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight Composition - How Much of Your Weight is Body Fat? | Pre-dietary intervention (baseline) and post-dietary intervention (week 52) | Percentage body fat as measured using bio-impedance weighing scales Although baseline data were recorded by the study team, inter-individual differences at the same timepoint indicated recorded measure of insufficient reliability to continue to record/report. |
| Change in Blood Pressure | Pre-dietary intervention (baseline) and end of study post-dietary intervention (week 52) | Measuring patients' blood pressure to see if it changes |
| Change in Blood Sugar Levels (Changes in the Blood Test Marker for Diabetes Called HbA1c) | Pre-dietary intervention (baseline) and end of study post-dietary intervention (week 52) | Change in blood sugar levels measured using the blood test marker for diabetes (glycemic control) called HbA1c |
| Energy Expenditure (How Efficiently Your Body Burns Calories) | Pre-dietary intervention (baseline) and end of study post-dietary intervention (week 52) | Measurement of whether the dietary intervention changes the rate at which your body burns calories |
| Change in Scores Across the Three Measured Domains (Emotional Eating, External Eating and Restrained Eating) on Dutch Eating Behaviours Questionnaire (DEBQ) | Pre-dietary intervention (baseline) and post-dietary intervention (week 52) | The DEBQ questionnaire completed by study participants to assess eating behaviour across three domains: Emotional eating - eating in response to negative emotions External eating - eating in response to external cues such as the sight or smell of food Restrained eating - the conscious limiting of food intake The DEBQ consists of 33 items grouped into the three categories: emotional eating (13 items), external eating (10 items) and restrained eating (10 items) Participant responses to each item range from 1 (never) to 5 (very often) with higher scores indicating a greater endorsement of the eating behaviour described in the question. The lowest total score for the DEBQ (combined for all three categories) is 33 indicating no behaviours relating to the three domains eating and the highest score is 165 indicating very frequent behaviours relating to the three domains. A lower score indicates healthy eating behaviours, a higher score indicates more problematic eating behaviours. |
| Measurement of Wellbeing and Quality of Life | Pre-dietary intervention (baseline) and post-dietary intervention (week 52) | This secondary outcome measures will be assessed using the Short Form-36 (SF-36) questionnaire. SF-36 is a participant completed questionnaire consisting of 36 questions relating to quality of life and well-being. Questions cover the following eight domains: Physical functioning Role limitation due to physical health Role limitation due to emotional problems Energy/fatigue Emotional wellbeing Social functioning Pain General Health Each of these domains is scored from 0 to 100 with a higher score indicating better quality of life and well-being. |
| Patient Drop-out Rate | Patient drop out will be recorded from the first patient group session (week 0) to the end of the study (week 52). | Patient drop out will be recorded. Drop out will be defined as a patient expressing the wish to drop out either verbally or in writing. A patient will also be considered to have dropped out of the study if they do not attend patient group sessions or fail to attend study visits without providing the investigators with an explanation for their non-attendance. Drop-out rate will be used as a surrogate marker of the acceptability of the intervention to patients. |
| Measurement of Eating Patterns, Hunger Levels and Relationship With Food | Pre-dietary intervention (baseline) and post-dietary intervention (week 52) | Three Factor Hunger Questionnaire: The TFEQ is a 51-item questionnaire completed by study participants to measure three areas (or factors) related to eating behaviour: cognitive restraint of eating (score 0 to 20), disinhibition (score 0 to 16), and hunger (score 0 to 15). The higher the score the greater the level of restrained eating, disinhibited eating and subjective feelings of/predisposition to feeling hungry. |
Participant flow
Pre-assignment details
Three participants in the I-SatPro group were excluded for the following reasons: psychiatric (n=1), medical (n=1), literacy (n=1) Two participants dropped out. Ten participants in the I-SatPro arm completed the study. Primary outcome data were available for: n=10 Zero participants in the control arm completed the study.
Participants by arm
| Arm | Count |
|---|---|
| I-SatPro Patients in the I-SatPro group will attend I-SatPro patient group sessions and follow the I-SatPro weight loss programme | 15 |
| Control Patients in the control group will attend established NHS Tier 3 patient group sessions (standard care) and follow the NHS Tier 3 weight loss programme | 6 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 3 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 5 |
Baseline characteristics
| Characteristic | I-SatPro | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 6 Participants | 20 Participants |
| Age, Continuous | 43.5 Years STANDARD_DEVIATION 8.6 | 42.8 Years STANDARD_DEVIATION 14.4 | 43.3 Years STANDARD_DEVIATION 10.2 |
| Body mass index (BMI) | 41.3 kg/m2 STANDARD_DEVIATION 9.4 | 45.3 kg/m2 STANDARD_DEVIATION 6 | 42.4 kg/m2 STANDARD_DEVIATION 8.6 |
| Race/Ethnicity, Customized Asian (other) | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black (African) | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black (Caribbean) | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Middle Eastern | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Mixed | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized South Asian | 5 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 5 Participants | 1 Participants | 6 Participants |
| Region of Enrollment United Kingdom | 15 Participants | 6 Participants | 21 Participants |
| Sex: Female, Male Female | 9 Participants | 4 Participants | 13 Participants |
| Sex: Female, Male Male | 6 Participants | 2 Participants | 8 Participants |
| Weight units: kg | 112.8 kg STANDARD_DEVIATION 24 | 133.1 kg STANDARD_DEVIATION 24.1 | 118.6 kg STANDARD_DEVIATION 25.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 6 |
| other Total, other adverse events | 0 / 15 | 0 / 6 |
| serious Total, serious adverse events | 0 / 15 | 0 / 6 |
Outcome results
Primary
Body Weight Change
Change in body weight will be measured from patient group session 1 (week 0) to the end of study (week 52)
Time frame: First patient group visit (week 0) to end of study (week 52)
Population: Baseline pre-dietary intervention and post-dietary intervention (week 52) data were available for n=10 participants in the I-SatPro group and body weight change was analyzed in these participants.~No patients were analysed for the control group: it was not possible to analyze change in body weight for the control group at the end of the study (week 52) as these data were not collected because no participants remained in this arm of the study at this timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I-SatPro | Body Weight Change | -12.99 kg | Standard Error 1.7 |
Comparison: I-SatPro starting weight Vs 52 week weight (kg)p-value: <0.0001t-test, 2 sided
Secondary
Body Weight Composition - How Much of Your Weight is Body Fat?
Percentage body fat as measured using bio-impedance weighing scales Although baseline data were recorded by the study team, inter-individual differences at the same timepoint indicated recorded measure of insufficient reliability to continue to record/report.
Time frame: Pre-dietary intervention (baseline) and post-dietary intervention (week 52)
Population: Participant baseline data are reported. One participant in the Control group was unable to comply with instructions for bio-impedance scale use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I-SatPro | Body Weight Composition - How Much of Your Weight is Body Fat? | 43.8 Percentage body fat (%) | Standard Error 2.3 |
| Control | Body Weight Composition - How Much of Your Weight is Body Fat? | 48.7 Percentage body fat (%) | Standard Error 2.9 |
Secondary
Change in Blood Pressure
Measuring patients' blood pressure to see if it changes
Time frame: Pre-dietary intervention (baseline) and end of study post-dietary intervention (week 52)
Population: Baseline pre-dietary intervention and post-dietary intervention (week 52) data were available for n= 9 participants in the I-SatPro group and change in blood pressure was analyzed in these participants.~No patients were analysed for the control group: it was not possible to analyze change in blood pressure for the control group at the end of the study (week 52) as these data were not collected because no participants remained in this arm of the study at this timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I-SatPro | Change in Blood Pressure | -6.0 mmHg | Standard Error 3.7 |
Secondary
Change in Blood Sugar Levels (Changes in the Blood Test Marker for Diabetes Called HbA1c)
Change in blood sugar levels measured using the blood test marker for diabetes (glycemic control) called HbA1c
Time frame: Pre-dietary intervention (baseline) and end of study post-dietary intervention (week 52)
Population: Baseline pre-dietary intervention and post-dietary intervention (week 52) data were available for n=9 participants in the I-SatPro group and change in HbA1c was analyzed in these participants.~No patients were analysed for the control group: it was not possible to analyze change in HbA1c for the control group at the end of the study (week 52) as these data were not collected because no participants remained in this arm of the study at this timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I-SatPro | Change in Blood Sugar Levels (Changes in the Blood Test Marker for Diabetes Called HbA1c) | -1.3 mmol/mol | Standard Error 1 |
Secondary
Change in Scores Across the Three Measured Domains (Emotional Eating, External Eating and Restrained Eating) on Dutch Eating Behaviours Questionnaire (DEBQ)
The DEBQ questionnaire completed by study participants to assess eating behaviour across three domains: Emotional eating - eating in response to negative emotions External eating - eating in response to external cues such as the sight or smell of food Restrained eating - the conscious limiting of food intake The DEBQ consists of 33 items grouped into the three categories: emotional eating (13 items), external eating (10 items) and restrained eating (10 items) Participant responses to each item range from 1 (never) to 5 (very often) with higher scores indicating a greater endorsement of the eating behaviour described in the question. The lowest total score for the DEBQ (combined for all three categories) is 33 indicating no behaviours relating to the three domains eating and the highest score is 165 indicating very frequent behaviours relating to the three domains. A lower score indicates healthy eating behaviours, a higher score indicates more problematic eating behaviours.
Time frame: Pre-dietary intervention (baseline) and post-dietary intervention (week 52)
Population: In analysis of this secondary outcome measure:~In the I-SatPro group: a set of baseline and week 52 data were available for n=7 participants No data were collected for the week 52 time point: in the control group baseline data were available for n=6 participants and post-dietary intervention (week 52) data were available for n=0 participants (please see pre-assignment details).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| I-SatPro | Change in Scores Across the Three Measured Domains (Emotional Eating, External Eating and Restrained Eating) on Dutch Eating Behaviours Questionnaire (DEBQ) | Total score restrained eating (baseline) Scale range: Minimum score: 10 Maximum score: 50 | 27.3 Score on a scale | Standard Deviation 4.2 |
| I-SatPro | Change in Scores Across the Three Measured Domains (Emotional Eating, External Eating and Restrained Eating) on Dutch Eating Behaviours Questionnaire (DEBQ) | Total score emotional eating (week 52) Scale range: Minimum score: 13 Maximum score: 65 | 28.3 Score on a scale | Standard Deviation 10.5 |
| I-SatPro | Change in Scores Across the Three Measured Domains (Emotional Eating, External Eating and Restrained Eating) on Dutch Eating Behaviours Questionnaire (DEBQ) | Total score external eating (baseline) Scale range: Minimum score: 10 Maximum score: 50 | 34.1 Score on a scale | Standard Deviation 7 |
| I-SatPro | Change in Scores Across the Three Measured Domains (Emotional Eating, External Eating and Restrained Eating) on Dutch Eating Behaviours Questionnaire (DEBQ) | Total score external eating (week 52) Scale range: Minimum score: 10 Maximum score: 50 | 19.3 Score on a scale | Standard Deviation 5.8 |
| I-SatPro | Change in Scores Across the Three Measured Domains (Emotional Eating, External Eating and Restrained Eating) on Dutch Eating Behaviours Questionnaire (DEBQ) | Total score restrained eating (week 52) Scale range: Minimum score: 10 Maximum score: 50 | 33.4 Score on a scale | Standard Deviation 8.8 |
| I-SatPro | Change in Scores Across the Three Measured Domains (Emotional Eating, External Eating and Restrained Eating) on Dutch Eating Behaviours Questionnaire (DEBQ) | Total score emotional eating (baseline) Scale range: Minimum score: 13 Maximum score: 65 | 53.3 Score on a scale | Standard Deviation 11.2 |
| Control | Change in Scores Across the Three Measured Domains (Emotional Eating, External Eating and Restrained Eating) on Dutch Eating Behaviours Questionnaire (DEBQ) | Total score restrained eating (baseline) Scale range: Minimum score: 10 Maximum score: 50 | 32.8 Score on a scale | Standard Deviation 7.2 |
| Control | Change in Scores Across the Three Measured Domains (Emotional Eating, External Eating and Restrained Eating) on Dutch Eating Behaviours Questionnaire (DEBQ) | Total score emotional eating (baseline) Scale range: Minimum score: 13 Maximum score: 65 | 35.8 Score on a scale | Standard Deviation 17.6 |
| Control | Change in Scores Across the Three Measured Domains (Emotional Eating, External Eating and Restrained Eating) on Dutch Eating Behaviours Questionnaire (DEBQ) | Total score external eating (baseline) Scale range: Minimum score: 10 Maximum score: 50 | 30.5 Score on a scale | Standard Deviation 6.4 |
Secondary
Energy Expenditure (How Efficiently Your Body Burns Calories)
Measurement of whether the dietary intervention changes the rate at which your body burns calories
Time frame: Pre-dietary intervention (baseline) and end of study post-dietary intervention (week 52)
Population: Resting energy expenditure corrected for body weight (kcal/kg)~In analysis of this secondary outcome measure:~Baseline pre-dietary intervention and post-dietary intervention (week 52) data were available for n=9 participants in the I-SatPro group.~Baseline data were available for n=4 out of 6 participants in the control group. No data were collected for the week 52 time point: data were available for n=0 participants post-dietary intervention (week 52) (please see pre-assignment details).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| I-SatPro | Energy Expenditure (How Efficiently Your Body Burns Calories) | Resting energy expenditure corrected for body weight (kcal/kg) pre-intervention (baseline) | 17.8 kcal/kg | Standard Error 1.4 |
| I-SatPro | Energy Expenditure (How Efficiently Your Body Burns Calories) | Resting energy expenditure corrected for body weight (kcal/kg) post-dietary intervention (week 52) | 18.0 kcal/kg | Standard Error 0.6 |
| Control | Energy Expenditure (How Efficiently Your Body Burns Calories) | Resting energy expenditure corrected for body weight (kcal/kg) pre-intervention (baseline) | 17.7 kcal/kg | Standard Error 0.8 |
Secondary
Measurement of Eating Patterns, Hunger Levels and Relationship With Food
Three Factor Hunger Questionnaire: The TFEQ is a 51-item questionnaire completed by study participants to measure three areas (or factors) related to eating behaviour: cognitive restraint of eating (score 0 to 20), disinhibition (score 0 to 16), and hunger (score 0 to 15). The higher the score the greater the level of restrained eating, disinhibited eating and subjective feelings of/predisposition to feeling hungry.
Time frame: Pre-dietary intervention (baseline) and post-dietary intervention (week 52)
Population: In analysis of this secondary outcome measure:~In the I-SatPro group: a set of baseline and week 52 data were available for n=7 participants No data were collected for the week 52 time point: in the control group baseline data were available for n=6 participants and post-dietary intervention (week 52) data were available for n=0 participants (please see pre-assignment details).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| I-SatPro | Measurement of Eating Patterns, Hunger Levels and Relationship With Food | Disinhibition score post-dietary intervention | 4.0 Score on a scale | Standard Deviation 2 |
| I-SatPro | Measurement of Eating Patterns, Hunger Levels and Relationship With Food | Hunger score pre-dietary intervention | 8.4 Score on a scale | Standard Deviation 4.6 |
| I-SatPro | Measurement of Eating Patterns, Hunger Levels and Relationship With Food | Cognitive restraint of eating pre-dietary intervention | 10.0 Score on a scale | Standard Deviation 2.6 |
| I-SatPro | Measurement of Eating Patterns, Hunger Levels and Relationship With Food | Cognitive restraint of eating post-dietary intervention | 10.4 Score on a scale | Standard Deviation 4 |
| I-SatPro | Measurement of Eating Patterns, Hunger Levels and Relationship With Food | Disinhibition score pre-dietary intervention | 11.1 Score on a scale | Standard Deviation 3.4 |
| I-SatPro | Measurement of Eating Patterns, Hunger Levels and Relationship With Food | Hunger score post-intervention | 0.7 Score on a scale | Standard Deviation 0.5 |
| Control | Measurement of Eating Patterns, Hunger Levels and Relationship With Food | Hunger score pre-dietary intervention | 6.8 Score on a scale | Standard Deviation 3.1 |
| Control | Measurement of Eating Patterns, Hunger Levels and Relationship With Food | Cognitive restraint of eating pre-dietary intervention | 9.7 Score on a scale | Standard Deviation 4.8 |
| Control | Measurement of Eating Patterns, Hunger Levels and Relationship With Food | Disinhibition score pre-dietary intervention | 8.5 Score on a scale | Standard Deviation 4.2 |
Secondary
Measurement of Wellbeing and Quality of Life
This secondary outcome measures will be assessed using the Short Form-36 (SF-36) questionnaire. SF-36 is a participant completed questionnaire consisting of 36 questions relating to quality of life and well-being. Questions cover the following eight domains: Physical functioning Role limitation due to physical health Role limitation due to emotional problems Energy/fatigue Emotional wellbeing Social functioning Pain General Health Each of these domains is scored from 0 to 100 with a higher score indicating better quality of life and well-being.
Time frame: Pre-dietary intervention (baseline) and post-dietary intervention (week 52)
Population: In analysis of this secondary outcome measure:~In the I-SatPro group: a set of baseline and week 52 data were available for n=7 participants No data were collected for the week 52 time point: in the control group baseline data were available for n=6 participants and post-dietary intervention (week 52) data were available for n=0 participants (please see pre-assignment details).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| I-SatPro | Measurement of Wellbeing and Quality of Life | SF-36 score general health post-dietary intervention (week 52) out of 100 | 85.0 Score on a scale | Standard Deviation 8.2 |
| I-SatPro | Measurement of Wellbeing and Quality of Life | SF-36 score emotional wellbeing pre-dietary intervention (baseline) out of 100 | 67.4 Score on a scale | Standard Deviation 15.4 |
| I-SatPro | Measurement of Wellbeing and Quality of Life | SF-36 score emotional wellbeing post-dietary intervention (week 52) out of 100 | 89.7 Score on a scale | Standard Deviation 6 |
| I-SatPro | Measurement of Wellbeing and Quality of Life | SF-36 score social functioning pre-dietary intervention (baseline) out of 100 | 62.5 Score on a scale | Standard Deviation 26 |
| I-SatPro | Measurement of Wellbeing and Quality of Life | SF-36 score social functioning post-dietary intervention (week 52) out of 100 | 98.2 Score on a scale | Standard Deviation 4.7 |
| I-SatPro | Measurement of Wellbeing and Quality of Life | SF-36 score pain pre-dietary intervention (baseline) out of 100 | 67.5 Score on a scale | Standard Deviation 29.9 |
| I-SatPro | Measurement of Wellbeing and Quality of Life | SF-36 score pain post-dietary intervention (week 52) out of 100 | 92.5 Score on a scale | Standard Deviation 12 |
| I-SatPro | Measurement of Wellbeing and Quality of Life | SF-36 score general health pre-dietary intervention (baseline) out of 100 | 47.1 Score on a scale | Standard Deviation 26.1 |
| I-SatPro | Measurement of Wellbeing and Quality of Life | SF-36 score physical functioning pre-dietary intervention (baseline) out of 100 | 70.0 Score on a scale | Standard Deviation 16.8 |
| I-SatPro | Measurement of Wellbeing and Quality of Life | SF-36 score physical functioning post-dietary intervention (week 52) out of 100 | 98.6 Score on a scale | Standard Deviation 2.4 |
| I-SatPro | Measurement of Wellbeing and Quality of Life | SF-36 score role limitation due to physical health pre-dietary intervention (baseline) out of 100 | 53.6 Score on a scale | Standard Deviation 46.6 |
| I-SatPro | Measurement of Wellbeing and Quality of Life | SF-36 score role limitation due to physical health post-dietary intervention (week 52) out of 100 | 100 Score on a scale | Standard Deviation 0 |
| I-SatPro | Measurement of Wellbeing and Quality of Life | SF-36 score role limitation due to emotional problems pre-dietary intervention (baseline) out of 100 | 76.2 Score on a scale | Standard Deviation 31.7 |
| I-SatPro | Measurement of Wellbeing and Quality of Life | SF-36 score role limitation due to emotional problems post-dietary intervention (week 52) out of 100 | 95.2 Score on a scale | Standard Deviation 12.6 |
| I-SatPro | Measurement of Wellbeing and Quality of Life | SF-36 score energy/fatigue pre-dietary intervention (baseline) out of 100 | 47.1 Score on a scale | Standard Deviation 13.8 |
| I-SatPro | Measurement of Wellbeing and Quality of Life | SF-36 score energy/fatigue post-dietary intervention (week 52) out of 100 | 86.4 Score on a scale | Standard Deviation 9 |
| Control | Measurement of Wellbeing and Quality of Life | SF-36 score physical functioning pre-dietary intervention (baseline) out of 100 | 45 Score on a scale | Standard Deviation 30.7 |
| Control | Measurement of Wellbeing and Quality of Life | SF-36 score pain pre-dietary intervention (baseline) out of 100 | 44.6 Score on a scale | Standard Deviation 18.5 |
| Control | Measurement of Wellbeing and Quality of Life | SF-36 score energy/fatigue pre-dietary intervention (baseline) out of 100 | 37.5 Score on a scale | Standard Deviation 16.4 |
| Control | Measurement of Wellbeing and Quality of Life | SF-36 score role limitation due to physical health pre-dietary intervention (baseline) out of 100 | 25.0 Score on a scale | Standard Deviation 38.7 |
| Control | Measurement of Wellbeing and Quality of Life | SF-36 score general health pre-dietary intervention (baseline) out of 100 | 31.7 Score on a scale | Standard Deviation 18.1 |
| Control | Measurement of Wellbeing and Quality of Life | SF-36 score social functioning pre-dietary intervention (baseline) out of 100 | 58.3 Score on a scale | Standard Deviation 25.8 |
| Control | Measurement of Wellbeing and Quality of Life | SF-36 score role limitation due to emotional problems pre-dietary intervention (baseline) out of 100 | 27.8 Score on a scale | Standard Deviation 39 |
| Control | Measurement of Wellbeing and Quality of Life | SF-36 score emotional wellbeing pre-dietary intervention (baseline) out of 100 | 56.7 Score on a scale | Standard Deviation 9.9 |
Secondary
Patient Drop-out Rate
Patient drop out will be recorded. Drop out will be defined as a patient expressing the wish to drop out either verbally or in writing. A patient will also be considered to have dropped out of the study if they do not attend patient group sessions or fail to attend study visits without providing the investigators with an explanation for their non-attendance. Drop-out rate will be used as a surrogate marker of the acceptability of the intervention to patients.
Time frame: Patient drop out will be recorded from the first patient group session (week 0) to the end of the study (week 52).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| I-SatPro | Patient Drop-out Rate | 2 Participants |
| Control | Patient Drop-out Rate | 5 Participants |