NCT00675662

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 8, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2008

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 13, 2016

Status Verified

September 1, 2015

Enrollment Period

4.7 years

First QC Date

May 8, 2008

Last Update Submit

January 12, 2016

Conditions

OverweightObesity

Keywords

ObesityoverweightBMIifestyledietnutritionphysical activitypre-schooltoddlerschildrenPrevention of overweight and obesity in pre-school children

Outcome Measures

Primary Outcomes (1)

  • Body Mass index

    12 months

Secondary Outcomes (6)

  • Cardiovascular (CV) disease risk factors

    12 months

  • Physical activity (accelerometry)

    12 months

  • Motor co-ordination (ABC battery).

    12 months

  • Motor co-ordination (ABC battery). Behaviour (general and dietary).

    12 months

  • CV fitness (heart rate variability).

    12 months

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Stratification by angiotensin converting enzyme (ACE) genotype

Behavioral: Lifestyle intervention

2

PLACEBO COMPARATOR

Waiting list controls

Behavioral: waiting list control

Interventions

Lifestyle interventionBEHAVIORAL

Lifestyle intervention with Trim Tots pre-school programme.

1
waiting list controlBEHAVIORAL

waiting list control

2

Eligibility Criteria

Age12 Months - 72 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Child Health, 30 Guilford Street

London, WC1N 1EH, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 16034868BACKGROUND

  • 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.

    PMID: 16371076BACKGROUND

Related Links

MeSH Terms

Conditions

OverweightObesityMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Julie Lanigan

    Institute of Child Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2008

First Posted

May 12, 2008

Study Start

April 1, 2008

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

January 13, 2016

Record last verified: 2015-09

Locations

GB(1)