Childhood ObesityNCT00407420
"Mandometer®" Study for Managing Childhood Obesity
A study testing Mandometer and Lifestyle in people with Childhood Obesity, run by University of Bristol at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Mandometer and Lifestyle
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2004to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Obese children and adolescents aged 10-18
Who cannot join
- Children:
- Having associated learning difficulties
- Who have received medication for associated insulin resistance
- Refusal of parent/legal guardian to give informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bristol Royal Hospital for Children
Bristol, BS2 8AE
About this study
Official title: Can a Novel Treatment Using "Mandometer®" Technology Improve Weight Loss in a Childhood Obesity Clinic?
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
Read the 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.
- Conditions
- Childhood Obesity
- Being tested
- Mandometer, Lifestyle
- Keywords
- Childhood, Obesity, Behavior modification, Insulin resistance
- Medical subject headings
- Pediatric Obesity, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MandometerDevice
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.
LifestyleBehavioural
Typical dietary and activity advice as normally provided in clinic (control).
| Study group | Role | What they receive |
|---|---|---|
| Mandometer | Experimental | Active intervention - one meal eaten per day off Mandometer Receives: Device: Mandometer; Behavioral: Lifestyle |
| Control | Active comparator | Nutritional and activity advice alone Receives: Device: Mandometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months primary/ 18 months secondary outcome
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startSep 2004
- Primary completionOct 2009
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bristol
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julian P Hamilton-Shield, MD, Principal investigator, University of Bristol and Bristol Royal Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407420
- Sponsor's protocol ID
- RJ4316
- Status last verified
- Sep 2019
- First submitted
- 1 Dec 2006
- Last updated
- 9 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 20051465
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Novel Treatment Using "Mandometer®" Technology Improve Weight Loss in a Childhood Obesity Clinic?
- ClinicalTrials.gov ID
- NCT00407420
- Acronym / sponsor ID
- RJ4316
- Conditions
- Childhood Obesity
- Keywords
- Childhood, Obesity, Behavior modification, Insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of BristolUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 5 Dec 2006 (estimated)
- Results
- Posted 30 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mandometer | Experimental | Device: Mandometer, Behavioral: LifestyleActive intervention - one meal eaten per day off Mandometer |
| Control | Active comparator | Device: MandometerNutritional and activity advice alone |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Obese children and adolescents aged 10-18
Key exclusion criteria (4 listed)
- Having associated learning difficulties
- Who have received medication for associated insulin resistance
- Refusal of parent/legal guardian to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MandometerA 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. | Device | Control, Mandometer |
| LifestyleTypical dietary and activity advice as normally provided in clinic (control). | Behavioural | Mandometer |
Primary outcome
BMI SDS or Z-score
Time frame: 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).
3 secondary outcomes
Insulin Sensitivity
Time frame: 12 months
Speed Food Consumed
Time frame: 12 months
Percentage Body Fat (Measured Using a Tanita Bio-impedance Monitor Model BC-418MA)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20051465Ford 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julian P Hamilton-Shield, MD principal investigator
University of Bristol and Bristol Royal Hospital for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandometer and Lifestyle in people with Childhood Obesity, run by University of Bristol at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI SDS or Z-score (time frame: 12 months primary/ 18 months secondary outcome). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00407420, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.