OverweightTrimTotsNCT00675662
Trim Tots Pre-school Obesity Prevention Programme
A study testing Lifestyle intervention in people with Overweight and Obesity, run by Institute of Child Health at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 12 to 72 monthsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 173 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2008to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 72 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children who are currently overweight/obese or at increased risk of becoming so and their mother or usual carer.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Child Health, 30 Guilford Street
London, WC1N 1EH
About this study
Official title: TrimTots Pre-school Obesity Prevention Programme
Randomised controlled trial of a lifestyle intervention programme for mothers and children aged 1-5 years aimed at prevention of overweight and obesity.
- Conditions
- Overweight, Obesity
- Being tested
- Lifestyle intervention, waiting list control
- Keywords
- Obesity, overweight, BMI, ifestyle, diet, nutrition, physical activity, pre-school, toddlers, children, Prevention of overweight and obesity in pre-school children
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
Lifestyle intervention with Trim Tots pre-school programme.
waiting list controlBehavioural
waiting list control
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Stratification by angiotensin converting enzyme (ACE) genotype Receives: Behavioral: Lifestyle intervention |
| 2 | Placebo comparator | Waiting list controls Receives: Behavioral: waiting list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass index
Measured: 12 months
Secondary outcomes (6)
Cardiovascular (CV) disease risk factors
Measured: 12 months
Physical activity (accelerometry)
Measured: 12 months
Motor co-ordination (ABC battery).
Measured: 12 months
Motor co-ordination (ABC battery). Behaviour (general and dietary).
Measured: 12 months
CV fitness (heart rate variability).
Measured: 12 months
Waist circumference
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Lanigan, Principal investigator, Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675662
- Sponsor's protocol ID
- 07NT14
- Acronym
- TrimTots
- Status last verified
- Sep 2015
- First submitted
- 8 May 2008
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16034868Flynn 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.
PubMed 16371076
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TrimTots Pre-school Obesity Prevention Programme
- ClinicalTrials.gov ID
- NCT00675662
- Acronym / sponsor ID
- TrimTots / 07NT14
- Conditions
- Overweight, Obesity
- Keywords
- Obesity, overweight, BMI, ifestyle, diet, nutrition, physical activity, pre-school
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 12 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomised controlled trial of a lifestyle intervention programme for mothers and children aged 1-5 years aimed at prevention of overweight and obesity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Lifestyle interventionStratification by angiotensin converting enzyme (ACE) genotype |
| 2 | Placebo comparator | Behavioral: waiting list controlWaiting list controls |
Who may qualify
- Ages
- 12 to 72 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children who are currently overweight/obese or at increased risk of becoming so and their mother or usual carer.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle interventionLifestyle intervention with Trim Tots pre-school programme. | Behavioural | 1 |
| waiting list controlwaiting list control | Behavioural | 2 |
Primary outcome
Body Mass index
Time frame: 12 months
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- Background: PubMed 16034868Summerbell 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.
- Background: PubMed 16371076Flynn 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.
- Obesity guidance on the prevention, identification, assessment and management of overweight and obesity in adults and children. National Institute for Health and Clinical Excellence.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Lanigan principal investigator
Institute of Child Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Overweight and Obesity, run by Institute of Child Health at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass index (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00675662, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016; AzTrials last refreshed its copy on 28 Oct 2026.