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We run a successful clinic in Bristol for children with severe obesity who already demonstrate many features to suggest they are at increased risk of early diabetes and heart disease. However, we have found that young children respond better to simple interventions than do adolescents. We have used a new treatment regimen "Mandometer®" to help our most difficult adolescent cases lose weight. We would like to do a study to see if all adolescents might improve weight loss using this technology compared to what we routinely offer
Childhood obesity is rapidly reaching epidemic proportions in the United Kingdom. Recent studies have indicated a prevalence level for obesity of 15% at 15 years of age. The implications for metabolic, cardiovascular and cancer risk in later life are enormous. The International Obesity Task Force (IOTF) and the European Association for the Study of Obesity (EASO) have identified childhood obesity as a matter for urgent attention. However, there are very few obesity clinics for children in the UK and effective treatment regimens are simply not available. We have developed an obesity clinic at the Royal Hospital for Children in Bristol and observed effective weight reduction in pre-pubertal children. Our simple treatment framework has proved far less effective in adolescence. We have therefore collaborated with an eating disorder clinic from the Karolinska Institute in Sweden to develop a novel therapy to treat obesity using modified equipment originally designed to treat adolescents with DSM-IV eating disorders. Pilot data indicate that adolescents are better able to address the issue of weight reduction within this treatment modality. Having established the software and treatment process we now wish to perform a randomised, control trial to test the efficacy of this new treatment against that currently provided.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mandometer | Experimental | Active intervention - one meal eaten per day off Mandometer |
|
| Control | Active Comparator | Nutritional and activity advice alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mandometer | Device | A computerised device, Mandometer, providing real time feedback to participants during meals to slow down speed of eating and reduce total intake; standard lifestyle modification therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| BMI SDS or Z-score | Body Mass Index standard deviation (s.d.) scores also called Z-scores, are measures of relative weight adjusted for a child's age and sex. In terms of this score for weight management, a lower score would be viewed a beneficial outcome at the end of the intervention. The change in BMI SDS was calculated as the value at 12 months minus value at baseline ( a negative score being beneficial). | 12 months primary/ 18 months secondary outcome |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity | Insulin sensitivity was measured by the homeostasis model assessment (HOMA-R) equation: HOMA-R = fasting glucose (mmol/l) × fasting insulin (mIU/l)/22.5. The lower the HOMA-R, the more insulin sensitive the participant is which is considered beneficial to metabolic health. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Children:
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| Name | Affiliation | Role |
|---|---|---|
| Julian P Hamilton-Shield, MD | University of Bristol and Bristol Royal Hospital for Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bristol Royal Hospital for Children | Bristol | BS2 8AE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20051465 | Result | Ford AL, Bergh C, Sodersten P, Sabin MA, Hollinghurst S, Hunt LP, Shield JP. Treatment of childhood obesity by retraining eating behaviour: randomised controlled trial. BMJ. 2009 Jan 5;340:b5388. doi: 10.1136/bmj.b5388. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Allocated to Mandometer Group | Received Mandometer therapy and lifestyle advice. |
| FG001 | Control Arm | Received lifestyle advice alone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Allocated to Mandometer Group (54) | Received Mandometer therapy and lifestyle advice. |
| BG001 | Control Arm (52) | Received lifestyle advice alone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | BMI SDS or Z-score | Body Mass Index standard deviation (s.d.) scores also called Z-scores, are measures of relative weight adjusted for a child's age and sex. In terms of this score for weight management, a lower score would be viewed a beneficial outcome at the end of the intervention. The change in BMI SDS was calculated as the value at 12 months minus value at baseline ( a negative score being beneficial). | The 12 months data includes Z-score of patients completing study (Mandometer arm n=45, Standard arm n=46) and last recorded Z-score of those withdrawing (Mandometer n=9, Control n=6). At 18 months (6 months after intervention ended) data was available on 44 participants in the active (Mandometer group) and 43 from the control arm. | Posted | Mean | Standard Deviation | Z-Score | 12 months primary/ 18 months secondary outcome |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mandometer | Active intervention - one meal eaten per day off Mandometer mandometer Mandometer: A computerised device, Mandometer, providing real time feedback to participants during meals to slow down speed of eating and reduce total intake; standard lifestyle modification therapy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julian Hamilton-Shield | University of Bristol | 00441173420183 | j.p.h.shield@bristol.ac.uk |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Lifestyle | Behavioral | Typical dietary and activity advice as normally provided in clinic (control). |
|
| Speed Food Consumed |
Grams of food eaten per minute in Mandometer® arm compared to standard arm at baseline and 12 months. Reducing speed of eating improves satiety and reduces total food consumed at meals in our overall hypothesis. |
| 12 months |
| Percentage Body Fat (Measured Using a Tanita Bio-impedance Monitor Model BC-418MA) | Change in % body fat. Calculated as %body fat at end of intervention minus baseline. A negative value being viewed as beneficial outcome. | 12 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control | Nutritional and activity advice alone |
|
|
| Secondary | Insulin Sensitivity | Insulin sensitivity was measured by the homeostasis model assessment (HOMA-R) equation: HOMA-R = fasting glucose (mmol/l) × fasting insulin (mIU/l)/22.5. The lower the HOMA-R, the more insulin sensitive the participant is which is considered beneficial to metabolic health. | 90 patients completed the intervention study at 12 months. One additional patient withdrew from intervention but agreed to data collection at 12 months. Data unavailable for analysis on one patient allocated to Mandometer. | Posted | Geometric Mean | Full Range | Arbitary units | 12 months |
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|
|
| Secondary | Speed Food Consumed | Grams of food eaten per minute in Mandometer® arm compared to standard arm at baseline and 12 months. Reducing speed of eating improves satiety and reduces total food consumed at meals in our overall hypothesis. | In only 23 of control cases was baseline data available on eating speed which then could be analysed for change at 12 months. | Posted | Mean | Full Range | gms/min of food consumed | 12 months |
|
|
|
| Secondary | Percentage Body Fat (Measured Using a Tanita Bio-impedance Monitor Model BC-418MA) | Change in % body fat. Calculated as %body fat at end of intervention minus baseline. A negative value being viewed as beneficial outcome. | 90 patients completed the intervention study at 12 months. One additional patient withdrew from study but agreed to data collection at 12 months. Data unavailable for analysis on two patients allocated to Mandometer. | Posted | Mean | Standard Deviation | percentage of body fat | 12 months |
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| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Control | Nutritional and activity advice alone mandometer | 0 | 52 | 0 | 52 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |