An interventional study of Mandometer and Lifestyle in Childhood Obesity, sponsored by University of Bristol. Completed at 1 site in United Kingdom. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-10-09.
Sponsored by University of Bristol · Not applicable, Interventional, and Treatment
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.
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's enrollment of 106 is close to the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →University of Bristol is the lead sponsor of 22 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Children:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active intervention - one meal eaten per day off Mandometer
Device: Mandometer · Behavioral: Lifestyle
Nutritional and activity advice alone
Device: 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.
Typical dietary and activity advice as normally provided in clinic (control).
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
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
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
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
| Milestone | Allocated to Mandometer Group | Control Arm |
|---|---|---|
| Started | 54 | 52 |
| Completed | 45 | 46 |
| Not completed | 9 | 6 |
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).
| Z-Score | Mandometer | Control |
|---|---|---|
| Baseline | 3.29 ± 0.52 | 3.21 ± 0.45 |
| 12 months | 2.93 ± 0.72 | 3.07 ± 0.56 |
| 18 months | 2.88 ± 0.74 | 3.07 ± 0.54 |
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.
| Arbitary units | Allocated to Mandometer Group (54) | Control Arm (52) |
|---|---|---|
| Baseline | 4.04 (0.3 to 15.2) | 4.04 (1.5 to 15.1) |
| 12 months | 3.27 (0.8 to 13.4) | 3.77 (1.0 to 18.1) |
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.
| gms/min of food consumed | Allocated to Mandometer Group (54) | Control Arm (52) |
|---|---|---|
| Baseline | 29.8 (13.4 to 90.4) | 29.3 (12.6 to 63.9) |
| 12months | 26.4 (10.2 to 54.8) | 30.6 (12.3 to 54.7) |
Change in % body fat. Calculated as %body fat at end of intervention minus baseline. A negative value being viewed as beneficial outcome.
| percentage of body fat | Allocated to Mandometer Group (54) | Control Arm (52) |
|---|---|---|
| Baseline | 43.5 ± 7.8 | 43 ± 6.7 |
| 12 Months | 38.9 ± 8.5 | 41.6 ± 6.9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mandometer | — | 0/54 (0%) | 0/54 (0%) |
| Control | — | 0/52 (0%) | 0/52 (0%) |
| Age, Categorical(Participants) | Allocated to Mandometer Group (54) | Control Arm (52) | Total |
|---|---|---|---|
| <=18 years | 54 | 52 | 106 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Allocated to Mandometer Group (54) | Control Arm (52) | Total |
|---|---|---|---|
| Mean | 12.7 (9.0 to 16.9) | 12.5 (9.1 to 17.5) | 12.6 (9.0 to 17.5) |
| Sex: Female, Male(Participants) | Allocated to Mandometer Group (54) | Control Arm (52) | Total |
|---|---|---|---|
| Female | 30 | 29 | 59 |
| Male | 24 | 23 | 47 |
| Race and Ethnicity Not Collected(Participants) | Allocated to Mandometer Group (54) | Control Arm (52) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Allocated to Mandometer Group (54) | Control Arm (52) | Total |
|---|---|---|---|
| United Kingdom | 54 | 52 | 106 |
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Bristol