N/A
Completed N=106
"Mandometer®" Study for Managing Childhood Obesity
Source: ClinicalTrials.gov NCT00407420 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: BMI SDS or Z-score — 3.29; 3.21; 2.93; 3.07 Z-Score
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BMI SDS or Z-score |
3.29; 3.21; 2.93; 3.07; 2.88; 3.07 | — |
| SECONDARY Insulin Sensitivity |
4.04; 4.04; 3.27; 3.77 | — |
| SECONDARY Speed Food Consumed |
29.8; 29.3; 26.4; 30.6 | — |
| SECONDARY Percentage Body Fat (Measured Using a Tanita Bio-impedance Monitor Model BC-418MA) |
43.5; 43; 38.9; 41.6 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00407420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.