Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/01/2006
Date assigned
17/02/2006
Last edited
18/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Barrie Margetts

ORCID ID

Contact details

Institute of Human Nutrition
University of Southampton
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
+44 (0)23 8079 4776
B.M.Margetts@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

J03

Study information

Scientific title

Comparing the effectiveness of multidisciplinary family approach with traditional dietetic treatment in managing the weight of overweight or obese children

Acronym

Study hypothesis

That a multidisciplinary family approach will be more effective in managing weight than usual care

Ethics approval

Health and Social Services Ethics Committee, Jersey

Study design

Randomised cross-over design

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Overweight or obese children

Intervention

Family support and activity versus usual care

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Weight

Secondary outcome measures

1. Percentage body fat
2. Nutritional balance
3. Physical activity
4. Self-esteem
5. Body image

Overall trial start date

01/10/2004

Overall trial end date

30/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Overweight or obese children between 6 to 14 years of age

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

40 children

Participant exclusion criteria

1. Any medical condition preventing safe exercising
2. Inability to attend without parent or guardian

Recruitment start date

01/10/2004

Recruitment end date

30/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Southampton
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

University of Southampton, Institute of Human Nutrition (UK)

Sponsor details

Public Health Nutrition
Institute of Human Nutrition
University of Southampton
Level E (893)
Centre Block
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Wessex Medical Trust 300175

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

2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21487425

Publication citations

Additional files

Editorial Notes

18/10/2016: Publication reference added.