Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/09/2004
Date assigned
06/10/2004
Last edited
21/04/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.mendprogramme.org/the_research/

Contact information

Type

Scientific

Primary contact

Mr Paul Sacher

ORCID ID

Contact details

MRC Childhood Nutrition Research Centre
Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7905 2258
p.sacher@ich.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N&AHP/02/RDA/033

Study information

Scientific title

Acronym

MEND (Mind, Exercise, Nutrition and Diet)

Study hypothesis

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

MREC approval gained.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Waist circumference

Secondary outcome measures

Body composition, weight, height, Body Mass Index (BMI), self- esteem, family functioning, child mental health, cardiovascular fitness and dietary intake and composition.

Overall trial start date

01/04/2005

Overall trial end date

13/01/2007

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

100

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/2005

Recruitment end date

13/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Childhood Nutrition Research Centre
London
WC1N 1EH
United Kingdom

Sponsor information

Organisation

UK Department of Health

Sponsor details

Blenheim House
Duncombe Street
Leeds
LS1 4PL
United Kingdom
+44 (0)113 254 3837
barbara.sutherland@doh.gsi.gov.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Department of Health (UK) (ref: N&AHP/02/RDA/033)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Sainsbury's Supermarkets Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20107463

Publication citations

  1. Results

    Sacher PM, Kolotourou M, Chadwick PM, Cole TJ, Lawson MS, Lucas A, Singhal A, Randomized controlled trial of the MEND program: a family-based community intervention for childhood obesity., Obesity (Silver Spring), 2010, 18 Suppl 1, S62-8, doi: 10.1038/oby.2009.433.

Additional files

Editorial Notes