Trim Tots Pre-school Obesity Prevention Programme

Obesity Clinical Trial

— TrimTots  

Official title:

TrimTots Pre-school Obesity Prevention Programme

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00675662
• Other study ID #: 07NT14
• Status: Completed
• Phase: N/A
• First received: May 8, 2008
• Last updated: January 12, 2016
• Start date: April 2008
• Est. completion date: January 2013

Study information

• Verified date: September 2015
• Source: Institute of Child Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 72 Months

Eligibility

Inclusion Criteria:

• Children who are currently overweight/obese or at increased risk of becoming so and their mother or usual carer.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Lifestyle intervention
Lifestyle intervention with Trim Tots pre-school programme.
• waiting list control
waiting list control

Locations

Country	Name	City	State
United Kingdom	Institute of Child Health, 30 Guilford Street	London

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Child Health

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Flynn MA, McNeil DA, Maloff B, Mutasingwa D, Wu M, Ford C, Tough SC. Reducing obesity and related chronic disease risk in children and youth: a synthesis of evidence with 'best practice' recommendations. Obes Rev. 2006 Feb;7 Suppl 1:7-66. Review. — View Citation

Summerbell CD, Waters E, Edmunds LD, Kelly S, Brown T, Campbell KJ. Interventions for preventing obesity in children. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD001871. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass index		12 months	No
Secondary	Cardiovascular (CV) disease risk factors		12 months	No
Secondary	Physical activity (accelerometry)		12 months	No
Secondary	Motor co-ordination (ABC battery).		12 months	No
Secondary	Motor co-ordination (ABC battery). Behaviour (general and dietary).		12 months	No
Secondary	CV fitness (heart rate variability).		12 months	No
Secondary	Waist circumference		12 months	No

External Links

•   Obesity guidance on the prevention, identification, assessment and management of overweight and obesity in adults and children. National Institute for Health and Clinical Excellence.