Improving health outcomes in obese children: a randomised controlled trial of the MEND programme

ISRCTN	ISRCTN30238779
DOI	https://doi.org/10.1186/ISRCTN30238779
Protocol serial number	N&AHP/02/RDA/033
Sponsor	UK Department of Health
Funders	Department of Health (UK) (ref: N&AHP/02/RDA/033), Sainsbury's Supermarkets Ltd (UK)

Submission date: 13/09/2004
Registration date: 06/10/2004
Last edited: 21/04/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Paul Sacher
Scientific

MRC Childhood Nutrition Research Centre
Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom

Phone	+44 (0)20 7905 2258
Email	p.sacher@ich.ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	MEND (Mind, Exercise, Nutrition and Diet)
Study objectives	Current hypothesis as of 28/06/2007: We propose a randomised controlled trial in obese 8 - 12 year old children to test the hypothesis that an intensive family-based programme of nutrition education, exercise and behavioural modification, followed by free access to leisure facilities will improve body composition, cardiovascular fitness and self-esteem in obese school-aged children compared to a waiting list control group. The trial will be conservatively powered, with outcomes relevant to public health and the NHS Plan and could provide the first proven childhood obesity intervention programme in the UK. Previous hypothesis: We propose a randomised controlled trial in obese 8 - 11 year old children to test the hypothesis that an intensive family-based programme of nutrition education, exercise and behavioural modification, followed by free access to leisure facilities will improve body composition, cardiovascular fitness and self-esteem in obese school-aged children compared to a waiting list control group. The trial will be conservatively powered, with outcomes relevant to public health and the NHS Plan and could provide the first proven childhood obesity intervention programme in the UK.
Ethics approval(s)	MREC approval gained.
Health condition(s) or problem(s) studied	Childhood Obesity
Intervention	Please note that this trial has concluded; the official end date of this trial was 13th January 2007. The previous end date for this trial was 30/04/2008. Interventions: Childhood obesity treatment programme combining nutrition education, behavioural modification and physical activity.
Intervention type	Other
Primary outcome measure(s)	Waist circumference
Key secondary outcome measure(s)	Body composition, weight, height, Body Mass Index (BMI), self- esteem, family functioning, child mental health, cardiovascular fitness and dietary intake and composition.
Completion date	13/01/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	8 Years
Upper age limit	12 Years
Sex	All
Target sample size at registration	100
Key inclusion criteria	Current inclusion criteria as of 28/06/2007: Obese 8 - 12 year old children and their families. Previous inclusion criteria: Obese 8 - 11 year old children and their families.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/04/2005
Date of final enrolment	13/01/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

MRC Childhood Nutrition Research Centre

London
WC1N 1EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2010		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes