OverweightNCT01127412
Early Obesity Intervention Program Within GECKO Drenthe; a Randomized Controlled Trial
A study testing Physical activity stimulating program in people with Overweight and Physical Activity, run by University Medical Center Groningen.
Trial summary
The purpose of this study is to investigate whether stimulating physical activity during the first year of life influences growth and body composition, and stimulates motor activity and motor development Read more about this study
- Who is it for?
- Ages Up to 2 weeksHealthy volunteers can take part
- Conditions the study is for
- Overweight, Physical Activity
- What is being tested?
- Physical activity stimulating program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Dec 2009
- 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 Up to 2 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- date of birth (December 2006-February 2008)
- area of living (around Meppel and Hoogeveen in the province of Drenthe, one of the Northern provinces of the Netherlands)
Who cannot join
- Children under care of child physiotherapists will be excluded from the program
About this study
The purpose of this study is to investigate whether stimulating physical activity during the first year of life influences growth and body composition, and stimulates motor activity and motor development
- Conditions
- Overweight, Physical Activity
- Being tested
- Physical activity stimulating program
- Keywords
- overweight, physical activity, infancy, body composition, motor development, motor activity
- Medical subject headings
- Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity stimulating programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Physical activity stimulating program | Active comparator | Advices to stimulate motor activity and motor development at the age of two weeks, two months, four months, eight months and eleven months Receives: Behavioral: Physical activity stimulating program |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth
Weight, length
Measured: Regularly during the first year of life, at 2.5 years of age
Body composition
Waist circumference, Hip circumference, Skin fold thickness, Bioelectrical impedance analyses (BIA)
Measured: Regularly during the first year of life, at 2.5 years of age
Secondary outcomes (2)
Motor activity
Accelerometer
Measured: At the age of 5 months, 8 months and 2.5 years of age
Motor development
Albertha Infant Motor Scale, Bayley Scales of Infant and Toddler Development
Measured: At the age of 5 months, 8 months and 2.5 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startDec 2006
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127412
- Sponsor's protocol ID
- EOIP-GECKO
- Status last verified
- May 2010
- First submitted
- 19 May 2010
- Last updated
- 20 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Obesity Intervention Program Within GECKO Drenthe; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01127412
- Acronym / sponsor ID
- EOIP-GECKO
- Conditions
- Overweight, Physical Activity
- Keywords
- overweight, physical activity, infancy, body composition, motor development, motor activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2009 (actual)
- First posted
- 20 May 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.
The purpose of this study is to investigate whether stimulating physical activity during the first year of life influences growth and body composition, and stimulates motor activity and motor development
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity stimulating program | Active comparator | Behavioral: Physical activity stimulating programAdvices to stimulate motor activity and motor development at the age of two weeks, two months, four months, eight months and eleven months |
| Control | No intervention | – |
Who may qualify
- Ages
- Up to 2 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- date of birth (December 2006-February 2008)
- area of living (around Meppel and Hoogeveen in the province of Drenthe, one of the Northern provinces of the Netherlands)
Key exclusion criteria (1 listed)
- Children under care of child physiotherapists will be excluded from the program
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 |
|---|---|---|
| Physical activity stimulating program | Behavioural | Physical activity stimulating program |
Primary outcome
Growth
Time frame: Regularly during the first year of life, at 2.5 years of age
Weight, length
Body composition
Time frame: Regularly during the first year of life, at 2.5 years of age
Waist circumference, Hip circumference, Skin fold thickness, Bioelectrical impedance analyses (BIA)
2 secondary outcomes
Motor activity
Time frame: At the age of 5 months, 8 months and 2.5 years of age
Motor development
Time frame: At the age of 5 months, 8 months and 2.5 years of age
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 20 May 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity stimulating program in people with Overweight and Physical Activity, run by University Medical Center Groningen.
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 2 inclusion and 1 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 20 May 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Growth (time frame: Regularly during the first year of life, at 2.5 years of age). The study lists 2 primary outcomes in all. 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 20 May 2010; AzTrials last refreshed its copy on 28 Oct 2026.