Trim Tots Pre-school Obesity Prevention Programme (TrimTots)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00675662
Recruitment Status : Completed
First Posted : May 12, 2008
Last Update Posted : January 13, 2016
Information provided by (Responsible Party):
Institute of Child Health

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

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: Lifestyle intervention Behavioral: waiting list control Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: TrimTots Pre-school Obesity Prevention Programme
Study Start Date : April 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Body Mass index [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Cardiovascular (CV) disease risk factors [ Time Frame: 12 months ]
  2. Physical activity (accelerometry) [ Time Frame: 12 months ]
  3. Motor co-ordination (ABC battery). [ Time Frame: 12 months ]
  4. Motor co-ordination (ABC battery). Behaviour (general and dietary). [ Time Frame: 12 months ]
  5. CV fitness (heart rate variability). [ Time Frame: 12 months ]
  6. Waist circumference [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 72 Months   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00675662

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

Additional Information:
Responsible Party: Institute of Child Health Identifier: NCT00675662     History of Changes
Other Study ID Numbers: 07NT14
First Posted: May 12, 2008    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: September 2015

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

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