Improving health outcomes in obese children: a randomised controlled trial of the MEND programme
| ISRCTN | ISRCTN30238779 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30238779 |
| Secondary identifying numbers | N&AHP/02/RDA/033 |
- 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
Not provided at time of registration
Contact information
Mr Paul Sacher
Scientific
Scientific
MRC Childhood Nutrition Research Centre
Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
| Phone | +44 (0)20 7905 2258 |
|---|---|
| p.sacher@ich.ucl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study 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(s) | MREC approval gained. |
| 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 |
| Primary outcome measure | 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 study start date | 01/04/2005 |
| Overall study end date | 13/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 100 |
| 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 exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 01/04/2005 |
| Recruitment end date | 13/01/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Childhood Nutrition Research Centre
London
WC1N 1EH
United Kingdom
WC1N 1EH
United Kingdom
Sponsor information
UK Department of Health
Government
Government
Blenheim House
Duncombe Street
Leeds
LS1 4PL
United Kingdom
| Phone | +44 (0)113 254 3837 |
|---|---|
| barbara.sutherland@doh.gsi.gov.uk | |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
Department of Health (UK) (ref: N&AHP/02/RDA/033)
No information available
Sainsbury's Supermarkets Ltd (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
