TrimTots: Trim Tots Pre-school Obesity Prevention Programme

• Sponsor: Institute of Child Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT00675662
• Collaborator: (none)
• Enrollment: 173
• Location: 1
• Arms: 2
• Duration (Months): 57
• Patients Per Site Per Month: 3

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Apr 1, 2008
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Body Mass index [12 months]

Secondary Outcome Measures

1. Cardiovascular (CV) disease risk factors [12 months]

2. Physical activity (accelerometry) [12 months]

3. Motor co-ordination (ABC battery). [12 months]

4. Motor co-ordination (ABC battery). Behaviour (general and dietary). [12 months]

5. CV fitness (heart rate variability). [12 months]

6. Waist circumference [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Months to 72 Months
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

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.

Publications

• 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.
• 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.

• Responsible Party: Institute of Child Health
• ClinicalTrials.gov Identifier: NCT00675662
• Other Study ID Numbers: 07NT14
• First Posted: May 12, 2008
• Last Update Posted: Jan 13, 2016
• Last Verified: Sep 1, 2015

• 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

Study Results

No Results Posted as of Jan 13, 2016