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Trim Tots Pre-school Obesity Prevention Programme (TrimTots)

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Lifestyle intervention
waiting list control
Sponsored by
Institute of Child Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Obesity, overweight, BMI, ifestyle, diet, nutrition, physical activity, pre-school, toddlers, children, Prevention of overweight and obesity in pre-school children

Eligibility Criteria

12 Months - 72 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

  • Institute of Child Health, 30 Guilford Street

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Stratification by angiotensin converting enzyme (ACE) genotype

Waiting list controls

Outcomes

Primary Outcome Measures

Body Mass index

Secondary Outcome Measures

Cardiovascular (CV) disease risk factors
Physical activity (accelerometry)
Motor co-ordination (ABC battery).
Motor co-ordination (ABC battery). Behaviour (general and dietary).
CV fitness (heart rate variability).
Waist circumference

Full Information

First Posted
May 8, 2008
Last Updated
January 12, 2016
Sponsor
Institute of Child Health
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1. Study Identification

Unique Protocol Identification Number
NCT00675662
Brief Title
Trim Tots Pre-school Obesity Prevention Programme
Acronym
TrimTots
Official Title
TrimTots Pre-school Obesity Prevention Programme
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Child Health

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Obesity, overweight, BMI, ifestyle, diet, nutrition, physical activity, pre-school, toddlers, children, Prevention of overweight and obesity in pre-school children

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Stratification by angiotensin converting enzyme (ACE) genotype
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Waiting list controls
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
Intervention Description
Lifestyle intervention with Trim Tots pre-school programme.
Intervention Type
Behavioral
Intervention Name(s)
waiting list control
Intervention Description
waiting list control
Primary Outcome Measure Information:
Title
Body Mass index
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cardiovascular (CV) disease risk factors
Time Frame
12 months
Title
Physical activity (accelerometry)
Time Frame
12 months
Title
Motor co-ordination (ABC battery).
Time Frame
12 months
Title
Motor co-ordination (ABC battery). Behaviour (general and dietary).
Time Frame
12 months
Title
CV fitness (heart rate variability).
Time Frame
12 months
Title
Waist circumference
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
72 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children who are currently overweight/obese or at increased risk of becoming so and their mother or usual carer.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Lanigan
Organizational Affiliation
Institute of Child Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Child Health, 30 Guilford Street
City
London
ZIP/Postal Code
WC1N 1EH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
16034868
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. doi: 10.1002/14651858.CD001871.pub2.
Results Reference
background
PubMed Identifier
16371076
Citation
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. doi: 10.1111/j.1467-789X.2006.00242.x.
Results Reference
background

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Trim Tots Pre-school Obesity Prevention Programme

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