Trial record 5 of 12 for:    toddler nutrition | Open Studies

Trim Tots Pre-School Obesity Prevention Programme

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Institute of Child Health.
Recruitment status was  Recruiting
Information provided by:
Institute of Child Health Identifier:
First received: May 8, 2008
Last updated: May 9, 2008
Last verified: May 2008

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
Behavioral: Lifestyle intervention
Behavioral: waiting list control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: TrimTots Pre-School Obesity Prevention Programme

Resource links provided by NLM:

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


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

Inclusion Criteria:

  • Children who are currently overweight/obese or at increased risk of becoming so and their mother or usual carer.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00675662

United Kingdom
Institute of Child Health, 30 Guilford Street Recruiting
London, United Kingdom, WC1N 1EH
Contact: Julie Lanigan   
Principal Investigator: Julie Lanigan         
Sponsors and Collaborators
Institute of Child Health
Principal Investigator: Julie Lanigan Institute of Child Health
  More Information

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

Keywords provided by Institute of Child Health:
physical activity
Prevention of overweight and obesity in pre-school children

Additional relevant MeSH terms:
Body Weight
Nutrition Disorders
Signs and Symptoms processed this record on August 27, 2015