Childhood Obesity
Conditions
Keywords
Childhood, Obesity, Behavior modification, Insulin resistance
Brief summary
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
Detailed description
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.
Interventions
DEVICEMandometer
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.
BEHAVIORALLifestyle
Typical dietary and activity advice as normally provided in clinic (control).
Sponsors
University of Bristol
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Obese children and adolescents aged 10-18
Exclusion criteria
Children: * Having associated learning difficulties * Who have received medication for associated insulin resistance * Refusal of parent/legal guardian to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMI SDS or Z-score | 12 months primary/ 18 months secondary outcome | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Sensitivity | 12 months | 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. |
| Speed Food Consumed | 12 months | 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. |
| Percentage Body Fat (Measured Using a Tanita Bio-impedance Monitor Model BC-418MA) | 12 months | Change in % body fat. Calculated as %body fat at end of intervention minus baseline. A negative value being viewed as beneficial outcome. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Allocated to Mandometer Group (54) Received Mandometer therapy and lifestyle advice. | 54 |
| Control Arm (52) Received lifestyle advice alone | 52 |
| Total | 106 |
Baseline characteristics
| Characteristic | Control Arm (52) | Total | Allocated to Mandometer Group (54) |
|---|---|---|---|
| Age, Categorical <=18 years | 52 Participants | 106 Participants | 54 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 12.5 years | 12.6 years | 12.7 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 52 participants | 106 participants | 54 participants |
| Sex: Female, Male Female | 29 Participants | 59 Participants | 30 Participants |
| Sex: Female, Male Male | 23 Participants | 47 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 54 | 0 / 52 |
| serious Total, serious adverse events | 0 / 54 | 0 / 52 |
Outcome results
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).
Time frame: 12 months primary/ 18 months secondary outcome
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mandometer | BMI SDS or Z-score | Baseline | 3.29 Z-Score | Standard Deviation 0.52 |
| Mandometer | BMI SDS or Z-score | 12 months | 2.93 Z-Score | Standard Deviation 0.72 |
| Mandometer | BMI SDS or Z-score | 18 months | 2.88 Z-Score | Standard Deviation 0.74 |
| Control | BMI SDS or Z-score | Baseline | 3.21 Z-Score | Standard Deviation 0.45 |
| Control | BMI SDS or Z-score | 12 months | 3.07 Z-Score | Standard Deviation 0.56 |
| Control | BMI SDS or Z-score | 18 months | 3.07 Z-Score | Standard Deviation 0.54 |
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Mandometer | Insulin Sensitivity | Baseline | 4.04 Arbitary units |
| Mandometer | Insulin Sensitivity | 12 months | 3.27 Arbitary units |
| Control | Insulin Sensitivity | Baseline | 4.04 Arbitary units |
| Control | Insulin Sensitivity | 12 months | 3.77 Arbitary units |
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mandometer | Percentage Body Fat (Measured Using a Tanita Bio-impedance Monitor Model BC-418MA) | Baseline | 43.5 percentage of body fat | Standard Deviation 7.8 |
| Mandometer | Percentage Body Fat (Measured Using a Tanita Bio-impedance Monitor Model BC-418MA) | 12 Months | 38.9 percentage of body fat | Standard Deviation 8.5 |
| Control | Percentage Body Fat (Measured Using a Tanita Bio-impedance Monitor Model BC-418MA) | Baseline | 43 percentage of body fat | Standard Deviation 6.7 |
| Control | Percentage Body Fat (Measured Using a Tanita Bio-impedance Monitor Model BC-418MA) | 12 Months | 41.6 percentage of body fat | Standard Deviation 6.9 |
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.
Time frame: 12 months
Population: In only 23 of control cases was baseline data available on eating speed which then could be analysed for change at 12 months.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mandometer | Speed Food Consumed | 12months | 26.4 gms/min of food consumed |
| Mandometer | Speed Food Consumed | Baseline | 29.8 gms/min of food consumed |
| Control | Speed Food Consumed | 12months | 30.6 gms/min of food consumed |
| Control | Speed Food Consumed | Baseline | 29.3 gms/min of food consumed |