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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
History of Changes
  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 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:

MedlinePlus related topics: Obesity
U.S. FDA Resources

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

  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

Publications:

Responsible Party: R&D Office, Institute of Child Health
ClinicalTrials.gov 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:
Obesity
Prevention of overweight and obesity in pre-school children
overweight
BMI
ifestyle
diet
 nutrition
physical activity
pre-school
toddlers
children

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013