ObesityLIFTNCT01204489
Lifestyle Intervention for Toddlers Pilot Study
A study testing Intensified dietary counseling at child wellfare clinics. in people with Obesity, run by Finnish Institute for Health and Welfare at 1 site in Finland.
Trial summary
Study aims to pilot a family-centred tailored nutrition intervention at child welfare clinics, targeting the previously observed dietary defaults of Finnish children. Read more about this study
- Who is it for?
- Ages 6 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Intensified dietary counseling at child wellfare clinics.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2010to May 2012
- 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 6 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- all families at their child's standard 6-month child welfare clinic visit
Who cannot join
- families with twins
- families who do not speak Finnish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lifestyle Intervention for Toddlers at Finnish Welfare Clinics
Study aims to pilot a family-centred tailored nutrition intervention at child welfare clinics, targeting the previously observed dietary defaults of Finnish children.
Read the detailed description
Eating habits can predict diet-related health problems and obesity. The defaults observed previously in the diet of Finnish children include low consumption of vegetables, fruits and vegetable oil-based fats, high consumption of sucrose, poor quality of drinks and low frequency of family meals. Child welfare clinic is the place to promote healthy lifestyles because most Finnish families visit there at regular intervals.
- Conditions
- Obesity
- Being tested
- Intensified dietary counseling at child wellfare clinics.
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensified dietary counseling at child wellfare clinics.Behavioural
The intervention is completed by public health nurses who receive updating education in nutrition. A special training in a family-centred lifestyle counseling method in implemented. The nutrition intervention consists of tailored dietary counseling, information leaflets and self-evaluation card given to the families in the intervention arm. In the control clinics, public health nurses continue their usual dietary counseling.
| Study group | Role | What they receive |
|---|---|---|
| Intensified dietary counseling | Experimental | The dietary intervention consists of tailored dietary counseling, information leaflets and self-evaluation cards given to the families. Receives: Behavioral: Intensified dietary counseling at child wellfare clinics. |
| Normal dietary counseling | Active comparator | Public health nurses continue their usual dietary counseling. Receives: Behavioral: Intensified dietary counseling at child wellfare clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To promote child's and family's healthy diet
Changes in family's dietary choices, knowledge and attitudes. Also changes in parent's motivation and self-efficiency to improve family's diet.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Tampere University, University of Helsinki, The Finnish Hearth Association, The Finnish Food Information
- Responsible party
- Sponsor
- Investigators
- Suvi M Virtanen, Professor, Principal investigator, Head of the Nutrition Unit, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204489
- Sponsor's protocol ID
- THL 10109
- Acronym
- LIFT
- Status last verified
- Jun 2011
- First submitted
- 16 Sep 2010
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention for Toddlers at Finnish Welfare Clinics
- ClinicalTrials.gov ID
- NCT01204489
- Acronym / sponsor ID
- LIFT / THL 10109
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Tampere University, University of Helsinki, The Finnish Hearth Association, The Finnish Food Information
- Study start
- Sep 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 Sep 2010 (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.
Study aims to pilot a family-centred tailored nutrition intervention at child welfare clinics, targeting the previously observed dietary defaults of Finnish children.
Detailed description
Eating habits can predict diet-related health problems and obesity. The defaults observed previously in the diet of Finnish children include low consumption of vegetables, fruits and vegetable oil-based fats, high consumption of sucrose, poor quality of drinks and low frequency of family meals. Child welfare clinic is the place to promote healthy lifestyles because most Finnish families visit there at regular intervals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensified dietary counseling | Experimental | Behavioral: Intensified dietary counseling at child wellfare clinics.The dietary intervention consists of tailored dietary counseling, information leaflets and self-evaluation cards given to the families. |
| Normal dietary counseling | Active comparator | Behavioral: Intensified dietary counseling at child wellfare clinics.Public health nurses continue their usual dietary counseling. |
Who may qualify
- Ages
- 6 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all families at their child's standard 6-month child welfare clinic visit
Key exclusion criteria (2 listed)
- families with twins
- families who do not speak Finnish
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 |
|---|---|---|
| Intensified dietary counseling at child wellfare clinics.The intervention is completed by public health nurses who receive updating education in nutrition. A special training in a family-centred lifestyle counseling method in implemented. The nutrition intervention consists of tailored dietary counseling, information leaflets and self-evaluation card given to the families in the intervention arm. In the control clinics, public health nurses continue their usual dietary counseling. | Behavioural | Intensified dietary counseling, Normal dietary counseling |
Primary outcome
To promote child's and family's healthy diet
Time frame: 8 months
Changes in family's dietary choices, knowledge and attitudes. Also changes in parent's motivation and self-efficiency to improve family's diet.
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 21 Jun 2012.
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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.
Suvi M Virtanen, Professor principal investigator
Head of the Nutrition Unit, professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensified dietary counseling at child wellfare clinics. in people with Obesity, run by Finnish Institute for Health and Welfare at 1 site in Finland.
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 2 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 21 Jun 2012. 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 Finland. 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. 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?
To promote child's and family's healthy diet (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2012.