OverweightSELFHNCT01012206
Overweighed Children´s Health - Studies of the Effect of Lifestyle and Food Habits
A study testing Intervention regarding food habits and physical activity. in people with Overweight and Obesity, run by Umeå University at 1 site in Sweden.
Trial summary
The aim is to investigate the development of overweight and obesity from infancy to school age, and to evaluate an intervention to prevent further development of overweight and obesity among children. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Intervention regarding food habits and physical activity.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2006to Jun 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age and gender adjusted body mass index (BMI) > 25
- born in 1995-1998
- living in or nearby the northern city of Umea, Sweden
Who cannot join
- no chronic disease that could influence metabolic parameters
- no attention deficit disorders
- no access to internet
Trial locations and contacts
1 site in 1 country.
About this study
The aim is to investigate the development of overweight and obesity from infancy to school age, and to evaluate an intervention to prevent further development of overweight and obesity among children.
A follow-up study will be conducted on 267 children and will allow comparison between children that developed overweight with the ones who did not. Subjects will be requited at 10 years of age from a previous project. These children have been studied when they were 6-18 months old and a follow-up was conducted at 4 years of age. Sixteen percent of the children were overweight at 4 years of age and retrospective data of e.g. food intake, blood lipids and anthropometric measurements exists. In the present follow-up data regarding food and physical activity habits, anthropometric measurements and blood samples of e.g. blood lipids, IGF1 will be collected.
An intervention study will be conducted on 80-120 overweight children that will be randomized into one intervention and one control group. An intervention during two years will encourage long term healthy habits regarding diet and physical activity through group meetings and supervision. Information about food habits will be collected through questionnaires, interviews and diaries. Measurement of physical activity and energy expenditure will be made with Sense Wear and double labeled water, and will be used to validate reported food intake. Further, anthropometric measurements and blood samples will be collected.
- Conditions
- Overweight, Obesity
- Being tested
- Intervention regarding food habits and physical activity.
- Keywords
- Children, Overweight, Obesity, Food habits, Dietary assessment, Physical activity
- Medical subject headings
- Overweight, Obesity, Feeding Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention regarding food habits and physical activity.Behavioural
Children in the intervention group participated in an intervention program regarding food habits and physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Children in control group obtained no lifestyle counseling (intervention). |
| Intervention group | Active comparator | Children in the intervention group and their parents were given lifestyle counseling and participated in an intervention program regarding food habits and physical activity. Receives: Behavioral: Intervention regarding food habits and physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Measured: Two years
Secondary outcomes (2)
Food intake
Measured: Two years
Physical activity
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startAug 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christel Larsson, Göteborg University
- Investigators
- Christel Larsson, PhD, Principal investigator, Department of Food and Nutrition, Umeå university.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012206
- Sponsor's protocol ID
- 05-088M
- Acronym
- SELFH
- Status last verified
- Sep 2016
- First submitted
- 10 Nov 2009
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Waling MU, Larsson CL. Energy intake of Swedish overweight and obese children is underestimated using a diet history interview. J Nutr. 2009 Mar;139(3):522-7. doi: 10.3945/jn.108.101311. Epub 2009 Jan 21.
PubMed 19158227
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overweighed Children´s Health - Studies of the Effect of Lifestyle and Food Habits
- ClinicalTrials.gov ID
- NCT01012206
- Acronym / sponsor ID
- SELFH / 05-088M
- Conditions
- Overweight, Obesity
- Keywords
- Children, Overweight, Obesity, Food habits, Dietary assessment, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 11 Nov 2009 (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 aim is to investigate the development of overweight and obesity from infancy to school age, and to evaluate an intervention to prevent further development of overweight and obesity among children.
A follow-up study will be conducted on 267 children and will allow comparison between children that developed overweight with the ones who did not. Subjects will be requited at 10 years of age from a previous project. These children have been studied when they were 6-18 months old and a follow-up was conducted at 4 years of age. Sixteen percent of the children were overweight at 4 years of age and retrospective data of e.g. food intake, blood lipids and anthropometric measurements exists. In the present follow-up data regarding food and physical activity habits, anthropometric measurements and blood samples of e.g. blood lipids, IGF1 will be collected.
An intervention study will be conducted on 80-120 overweight children that will be randomized into one intervention and one control group. An intervention during two years will encourage long term healthy habits regarding diet and physical activity through group meetings and supervision. Information about food habits will be collected through questionnaires, interviews and diaries. Measurement of physical activity and energy expenditure will be made with Sense Wear and double labeled water, and will be used to validate reported food intake. Further, anthropometric measurements and blood samples will be collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Children in control group obtained no lifestyle counseling (intervention). |
| Intervention group | Active comparator | Behavioral: Intervention regarding food habits and physical activity.Children in the intervention group and their parents were given lifestyle counseling and participated in an intervention program regarding food habits and physical activity. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age and gender adjusted body mass index (BMI) > 25
- born in 1995-1998
- living in or nearby the northern city of Umea, Sweden
Key exclusion criteria (3 listed)
- no chronic disease that could influence metabolic parameters
- no attention deficit disorders
- no access to internet
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 |
|---|---|---|
| Intervention regarding food habits and physical activity.Children in the intervention group participated in an intervention program regarding food habits and physical activity. | Behavioural | Intervention group |
Primary outcome
Body Mass Index
Time frame: Two years
2 secondary outcomes
Food intake
Time frame: Two years
Physical activity
Time frame: Two years
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 5 Sep 2016.
- Results publication: PubMed 19158227Waling MU, Larsson CL. Energy intake of Swedish overweight and obese children is underestimated using a diet history interview. J Nutr. 2009 Mar;139(3):522-7. doi: 10.3945/jn.108.101311. Epub 2009 Jan 21.
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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.
Christel Larsson, PhD principal investigator
Department of Food and Nutrition, Umeå university.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention regarding food habits and physical activity. in people with Overweight and Obesity, run by Umeå University at 1 site in Sweden.
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 3 inclusion and 3 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 5 Sep 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 Sweden. 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?
Body Mass Index (time frame: Two years). 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 NCT01012206, which also lists 1 linked publication.
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 5 Sep 2016.