| Methods |
Type of trial: interventional; randomised controlled trial
Allocation: randomised
Intervention model: parallel assignment
Masking: not reported
Primary purpose: treatment |
| Participants |
Condition: adolescent obesity
Enrolment: target 48
Inclusion criteria:
aged 12 to 18 years BMI > 95th centile for age and sex pubertal stage ≥ 3 ability for parent and child to read and understand written instructions in English; parents able to give informed written consent in English; adolescent able to give verbal assent successfully completed a 6‐month lifestyle intervention without a gain in BMI z‐score
Exclusion criteria:
renal disorders, diabetes, diagnosed psychological disorders taking stimulants or psychotropic medication or drugs known to alter metabolism including insulin sensitisers, glucocorticoids, thyroxine, other weight loss medications taking any drugs known to be contraindicated with metformin therapy known adverse reactions to metformin pregnancy
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| Interventions |
Intervention: metformin + lifestyle intervention
Comparator: placebo + lifestyle intervention |
| Outcomes |
Primary outcome:
Secondary outcomes:
subjective appetite sensations using a novel electronic appetite rating system (EARS), immediately before and then hourly for 4 hours after a fixed‐energy breakfast. Measured at baseline, day 1, week 2, week 4, then monthly. This is a validated technique of measuring appetite which has been used in appetite trials involving obese children food preferences will be measured using a novel 'liking and wanting' (L&W) experimental procedure. Measured at baseline, day 1, week 2, week 4, then monthly. This method has been validated in several trials. The L&W procedure is sensitive to detect changes in nutrient and taste preferences we will measure fasting gastrointestinal hormones (at baseline, day 28, 2 months and 6 months) to identify potential biomarkers which could explain any differences in appetite responses between the 2 groups. These will be correlated with fasting and postprandial subjective appetite sensations in a subset of participants (10 in each group), will measure gastrointestinal hormones and subjective sensations of appetite, pre‐ and postprandially (by insertion of an intravenous cannula) and pre‐ and postdosing with metformin (at baseline, each metformin dose increment (day 1, week 2, week 4), 2 months and 6 months)
Other outcomes: not reported |
| Study identifier |
ISRCTN number: ISRCTN08063839
Trial start date: 1 July 2010
Trial completion date: 30 June 2014 |
| Official title |
Investigating the use of pharmacotherapy in adolescents for weight loss maintenance: the role of appetite: a randomised, placebo controlled trial |
| Stated purpose of study |
Quote: "Eat Smart is a novel research study in which 2 dietary approaches to treat childhood obesity are being tested." |
| Notes |
Trial completed in 2014, no publication available and page not found on website
Trial sponsor: Royal Children's Hospital (Australia)
Ethics approved by the Human Research Ethics Committee (HREC) of the Royal Children's Hospital (ref: HREC/10/QRCH/53)
Sources of funding are:
Further information obtained from trial website: www2.som.uq.edu.au/som/Research/ResearchCentres/cnrc/Pages/CNRCHome.aspx
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