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Trim Tots Pre-school Obesity Prevention Programme (TrimTots)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institute of Child Health
ClinicalTrials.gov Identifier:
NCT00675662
First received: May 8, 2008
Last updated: January 12, 2016
Last verified: September 2015
  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
Overweight Obesity Behavioral: Lifestyle intervention Behavioral: waiting list control

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

Further study details as provided by Institute of Child Health:

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

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

Enrollment: 173
Study Start Date: April 2008
Study Completion Date: January 2013
Primary Completion Date: December 2012 (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   (Child)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
Publications:
Responsible Party: Institute of Child Health
ClinicalTrials.gov Identifier: NCT00675662     History of Changes
Other Study ID Numbers: 07NT14
Study First Received: May 8, 2008
Last Updated: January 12, 2016

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

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

ClinicalTrials.gov processed this record on August 16, 2017