Trim Tots Pre-School Obesity Prevention Programme - Full Text View

Sponsored by:	Institute of Child Health
Information provided by:	Institute of Child Health
ClinicalTrials.gov Identifier:	NCT00675662

Purpose

Randomised controlled trial of a lifestyle intervention programme for mothers and children aged 1-5 years aimed at prevention of overweight and obesity.

Condition	Intervention	Phase
Overweight Obesity	Behavioral: Lifestyle intervention Behavioral: waiting list control	Phase III

MedlinePlus related topics: Diets Obesity Obesity in Children

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Investigator), Factorial Assignment
Official Title:	TrimTots Pre-School Obesity Prevention Programme

Further study details as provided by Institute of Child Health:

Primary Outcome Measures:

Body Mass index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Waist circumference [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cardiovascular (CV) disease risk factors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Physical activity (accelerometry) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Motor co-ordination (ABC battery). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Motor co-ordination (ABC battery). Behaviour (general and dietary). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
CV fitness (heart rate variability). [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	96
Study Start Date:	April 2008
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Stratification by angiotensin converting enzyme (ACE) genotype	Behavioral: Lifestyle intervention Lifestyle intervention with Trim Tots pre-school programme.
2: Placebo Comparator Waiting list controls	Behavioral: waiting list control waiting list control

Eligibility

Ages Eligible for Study:	12 Months to 72 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Children who are currently overweight/obese or at increased risk of becoming so and their mother or usual carer.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675662

Locations

United Kingdom
Institute of Child Health, 30 Guilford Street	Recruiting
London, United Kingdom, WC1N 1EH
Contact: Julie Lanigan j.lanigan@ich.ucl.ac.uk
Principal Investigator: Julie Lanigan

Sponsors and Collaborators

Institute of Child Health

Investigators

Principal Investigator:

Julie Lanigan

Institute of Child Health

More Information

Additional Information:

Obesity guidance on the prevention, identification, assessment and management of overweight and obesity in adults and children. National Institute for Health and Clinical Excellence. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Summerbell CD, Waters E, Edmunds LD, Kelly S, Brown T, Campbell KJ. Interventions for preventing obesity in children. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD001871. Review.

Flynn MA, McNeil DA, Maloff B, Mutasingwa D, Wu M, Ford C, Tough SC. Reducing obesity and related chronic disease risk in children and youth: a synthesis of evidence with 'best practice' recommendations. Obes Rev. 2006 Feb;7 Suppl 1:7-66. Review.

Responsible Party:	Institute of Child Health ( R&D Office )
Study ID Numbers:	07NT14
Study First Received:	May 8, 2008
Last Updated:	May 9, 2008
ClinicalTrials.gov Identifier:	NCT00675662 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Institute of Child Health:

Obesity
overweight
BMI
ifestyle
diet
nutrition

physical activity
pre-school
toddlers
children
Prevention of overweight and obesity in pre-school children

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overnutrition
Overweight

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overnutrition
Overweight

ClinicalTrials.gov processed this record on May 07, 2009