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
Sponsor:
Information provided by:
Institute of Child Health
ClinicalTrials.gov Identifier:
NCT00675662
First received: May 8, 2008
Last updated: May 9, 2008
Last verified: May 2008

May 8, 2008
May 9, 2008
April 2008
September 2009   (final data collection date for primary outcome measure)
  • Body Mass index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00675662 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Trim Tots Pre-School Obesity Prevention Programme
TrimTots Pre-School Obesity Prevention Programme

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
  • Overweight
  • Obesity
  • Behavioral: Lifestyle intervention
    Lifestyle intervention with Trim Tots pre-school programme.
  • Behavioral: waiting list control
    waiting list control
  • Experimental: 1
    Stratification by angiotensin converting enzyme (ACE) genotype
    Intervention: Behavioral: Lifestyle intervention
  • Placebo Comparator: 2
    Waiting list controls
    Intervention: Behavioral: waiting list control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
96
Not Provided
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children who are currently overweight/obese or at increased risk of becoming so and their mother or usual carer.
Both
12 Months to 72 Months
Yes
Not Provided
United Kingdom
 
NCT00675662
07NT14
No
R&D Office, Institute of Child Health
Institute of Child Health
Not Provided
Principal Investigator: Julie Lanigan Institute of Child Health
Institute of Child Health
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP