Trial Outcomes & Findings for "Mandometer®" Study for Managing Childhood Obesity (NCT NCT00407420)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

106 participants

Primary outcome timeframe

12 months primary/ 18 months secondary outcome

Results posted on

2019-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	Allocated to Mandometer Group Received Mandometer therapy and lifestyle advice.	Control Arm Received lifestyle advice alone
Overall Study STARTED	54	52
Overall Study COMPLETED	45	46
Overall Study NOT COMPLETED	9	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Allocated to Mandometer Group (54) n=54 Participants Received Mandometer therapy and lifestyle advice.	Control Arm (52) n=52 Participants Received lifestyle advice alone	Total n=106 Participants Total of all reporting groups
Age, Categorical <=18 years	54 Participants n=54 Participants	52 Participants n=52 Participants	106 Participants n=106 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=54 Participants	0 Participants n=52 Participants	0 Participants n=106 Participants
Age, Categorical >=65 years	0 Participants n=54 Participants	0 Participants n=52 Participants	0 Participants n=106 Participants
Age, Continuous	12.7 years n=54 Participants	12.5 years n=52 Participants	12.6 years n=106 Participants
Sex: Female, Male Female	30 Participants n=54 Participants	29 Participants n=52 Participants	59 Participants n=106 Participants
Sex: Female, Male Male	24 Participants n=54 Participants	23 Participants n=52 Participants	47 Participants n=106 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	54 participants n=54 Participants	52 participants n=52 Participants	106 participants n=106 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Mandometer n=54 Participants 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.	Control n=52 Participants Nutritional and activity advice alone
BMI SDS or Z-score Baseline	3.29 Z-Score Standard Deviation 0.52	3.21 Z-Score Standard Deviation 0.45
BMI SDS or Z-score 12 months	2.93 Z-Score Standard Deviation 0.72	3.07 Z-Score Standard Deviation 0.56
BMI SDS or Z-score 18 months	2.88 Z-Score Standard Deviation 0.74	3.07 Z-Score Standard Deviation 0.54

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Mandometer n=44 Participants 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.	Control n=46 Participants Nutritional and activity advice alone
Insulin Sensitivity Baseline	4.04 Arbitary units Interval 0.3 to 15.2	4.04 Arbitary units Interval 1.5 to 15.1
Insulin Sensitivity 12 months	3.27 Arbitary units Interval 0.8 to 13.4	3.77 Arbitary units Interval 1.0 to 18.1

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Mandometer n=44 Participants 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.	Control n=23 Participants Nutritional and activity advice alone
Speed Food Consumed Baseline	29.8 gms/min of food consumed Interval 13.4 to 90.4	29.3 gms/min of food consumed Interval 12.6 to 63.9
Speed Food Consumed 12months	26.4 gms/min of food consumed Interval 10.2 to 54.8	30.6 gms/min of food consumed Interval 12.3 to 54.7

SECONDARY outcome

Timeframe: 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.

Change in % body fat. Calculated as %body fat at end of intervention minus baseline. A negative value being viewed as beneficial outcome.

Outcome measures

Outcome measures
Measure	Mandometer n=43 Participants 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.	Control n=46 Participants Nutritional and activity advice alone
Percentage Body Fat (Measured Using a Tanita Bio-impedance Monitor Model BC-418MA) Baseline	43.5 percentage of body fat Standard Deviation 7.8	43 percentage of body fat Standard Deviation 6.7
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	41.6 percentage of body fat Standard Deviation 6.9

Adverse Events

Mandometer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julian Hamilton-Shield

University of Bristol

Phone: 00441173420183

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place