Trial Outcomes & Findings for Investigation of a New Diet for the Treatment of Obesity in the NHS (NCT NCT05249439)
NCT ID: NCT05249439
Last Updated: 2025-03-21
Results Overview
Change in body weight will be measured from patient group session 1 (week 0) to the end of study (week 52)
COMPLETED
NA
21 participants
First patient group visit (week 0) to end of study (week 52)
2025-03-21
Participant Flow
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.
Participant milestones
| Measure |
I-SatPro
Patients in the I-SatPro group will attend I-SatPro patient group sessions and follow the I-SatPro weight loss programme
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
6
|
|
Overall Study
COMPLETED
|
10
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
I-SatPro
Patients in the I-SatPro group will attend I-SatPro patient group sessions and follow the I-SatPro weight loss programme
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
|
Overall Study
Physician Decision
|
3
|
1
|
Baseline Characteristics
Investigation of a New Diet for the Treatment of Obesity in the NHS
Baseline characteristics by cohort
| Measure |
I-SatPro
n=15 Participants
Patients in the I-SatPro group will attend I-SatPro patient group sessions and follow the I-SatPro weight loss programme
|
Control
n=6 Participants
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
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
43.5 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
42.8 Years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
43.3 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
South Asian
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black (Caribbean)
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black (African)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian (other)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Weight units: kg
|
112.8 kg
STANDARD_DEVIATION 24.0 • n=5 Participants
|
133.1 kg
STANDARD_DEVIATION 24.1 • n=7 Participants
|
118.6 kg
STANDARD_DEVIATION 25.2 • n=5 Participants
|
|
Body mass index (BMI)
|
41.3 kg/m2
STANDARD_DEVIATION 9.4 • n=5 Participants
|
45.3 kg/m2
STANDARD_DEVIATION 6.0 • n=7 Participants
|
42.4 kg/m2
STANDARD_DEVIATION 8.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Change in body weight will be measured from patient group session 1 (week 0) to the end of study (week 52)
Outcome measures
| Measure |
I-SatPro
n=10 Participants
Patients in the I-SatPro group will attend I-SatPro patient group sessions and follow the I-SatPro weight loss programme
|
Control
Patients in the control group will attend established NHS Tier 3 patient group sessions (standard clinical care) and follow the Imperial Weight Centre Tier 3 weight loss programme
|
|---|---|---|
|
Body Weight Change
|
-12.99 kg
Standard Error 1.7
|
—
|
SECONDARY outcome
Timeframe: 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).
Measurement of whether the dietary intervention changes the rate at which your body burns calories
Outcome measures
| Measure |
I-SatPro
n=9 Participants
Patients in the I-SatPro group will attend I-SatPro patient group sessions and follow the I-SatPro weight loss programme
|
Control
n=4 Participants
Patients in the control group will attend established NHS Tier 3 patient group sessions (standard clinical care) and follow the Imperial Weight Centre Tier 3 weight loss programme
|
|---|---|---|
|
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
|
17.7 kcal/kg
Standard Error 0.8
|
|
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
|
—
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
I-SatPro
n=9 Participants
Patients in the I-SatPro group will attend I-SatPro patient group sessions and follow the I-SatPro weight loss programme
|
Control
n=5 Participants
Patients in the control group will attend established NHS Tier 3 patient group sessions (standard clinical care) and follow the Imperial Weight Centre Tier 3 weight loss programme
|
|---|---|---|
|
Body Weight Composition - How Much of Your Weight is Body Fat?
|
43.8 Percentage body fat (%)
Standard Error 2.3
|
48.7 Percentage body fat (%)
Standard Error 2.9
|
SECONDARY outcome
Timeframe: 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.
Measuring patients' blood pressure to see if it changes
Outcome measures
| Measure |
I-SatPro
n=9 Participants
Patients in the I-SatPro group will attend I-SatPro patient group sessions and follow the I-SatPro weight loss programme
|
Control
Patients in the control group will attend established NHS Tier 3 patient group sessions (standard clinical care) and follow the Imperial Weight Centre Tier 3 weight loss programme
|
|---|---|---|
|
Change in Blood Pressure
|
-6.0 mmHg
Standard Error 3.7
|
—
|
SECONDARY outcome
Timeframe: 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.
Change in blood sugar levels measured using the blood test marker for diabetes (glycemic control) called HbA1c
Outcome measures
| Measure |
I-SatPro
n=9 Participants
Patients in the I-SatPro group will attend I-SatPro patient group sessions and follow the I-SatPro weight loss programme
|
Control
Patients in the control group will attend established NHS Tier 3 patient group sessions (standard clinical care) and follow the Imperial Weight Centre Tier 3 weight loss programme
|
|---|---|---|
|
Change in Blood Sugar Levels (Changes in the Blood Test Marker for Diabetes Called HbA1c)
|
-1.3 mmol/mol
Standard Error 1.0
|
—
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
I-SatPro
n=7 Participants
Patients in the I-SatPro group will attend I-SatPro patient group sessions and follow the I-SatPro weight loss programme
|
Control
n=6 Participants
Patients in the control group will attend established NHS Tier 3 patient group sessions (standard clinical care) and follow the Imperial Weight Centre Tier 3 weight loss programme
|
|---|---|---|
|
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
|
6.8 Score on a scale
Standard Deviation 3.1
|
|
Measurement of Eating Patterns, Hunger Levels and Relationship With Food
Hunger score post-intervention
|
0.7 Score on a scale
Standard Deviation 0.5
|
—
|
|
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
|
9.7 Score on a scale
Standard Deviation 4.8
|
|
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 4.0
|
—
|
|
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
|
8.5 Score on a scale
Standard Deviation 4.2
|
|
Measurement of Eating Patterns, Hunger Levels and Relationship With Food
Disinhibition score post-dietary intervention
|
4.0 Score on a scale
Standard Deviation 2.0
|
—
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
I-SatPro
n=7 Participants
Patients in the I-SatPro group will attend I-SatPro patient group sessions and follow the I-SatPro weight loss programme
|
Control
n=6 Participants
Patients in the control group will attend established NHS Tier 3 patient group sessions (standard clinical care) and follow the Imperial Weight Centre Tier 3 weight loss programme
|
|---|---|---|
|
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
|
32.8 Score on a scale
Standard Deviation 7.2
|
|
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
|
—
|
|
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
|
35.8 Score on a scale
Standard Deviation 17.6
|
|
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
|
—
|
|
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 7.0
|
30.5 Score on a scale
Standard Deviation 6.4
|
|
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
|
—
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
I-SatPro
n=7 Participants
Patients in the I-SatPro group will attend I-SatPro patient group sessions and follow the I-SatPro weight loss programme
|
Control
n=6 Participants
Patients in the control group will attend established NHS Tier 3 patient group sessions (standard clinical care) and follow the Imperial Weight Centre Tier 3 weight loss programme
|
|---|---|---|
|
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
|
44.6 Score on a scale
Standard Deviation 18.5
|
|
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
|
45 Score on a scale
Standard Deviation 30.7
|
|
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
|
—
|
|
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
|
25.0 Score on a scale
Standard Deviation 38.7
|
|
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
|
—
|
|
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
|
27.8 Score on a scale
Standard Deviation 39.0
|
|
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
|
—
|
|
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
|
37.5 Score on a scale
Standard Deviation 16.4
|
|
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 9.0
|
—
|
|
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
|
56.7 Score on a scale
Standard Deviation 9.9
|
|
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 6.0
|
—
|
|
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 26.0
|
58.3 Score on a scale
Standard Deviation 25.8
|
|
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
|
—
|
|
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 12.0
|
—
|
|
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
|
31.7 Score on a scale
Standard Deviation 18.1
|
|
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
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
I-SatPro
n=15 Participants
Patients in the I-SatPro group will attend I-SatPro patient group sessions and follow the I-SatPro weight loss programme
|
Control
n=6 Participants
Patients in the control group will attend established NHS Tier 3 patient group sessions (standard clinical care) and follow the Imperial Weight Centre Tier 3 weight loss programme
|
|---|---|---|
|
Patient Drop-out Rate
|
2 Participants
|
5 Participants
|
Adverse Events
I-SatPro
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place