Health BehaviorNCT02290171
Promoting Health in Healthy Living Centres - a Clinical Study Among Children
A study testing Activity groups, Group based dietary counselling and Individual counselling in people with Health Behavior, run by Eivind Meland at 2 sites in Norway.
Trial summary
The overall aim is to evaluate if a familybased intervention, targeting overweight and obese children and their parents, has a long-term positive effect on weight development and health of the children. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Activity groups, Group based dietary counselling and Individual counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 2 sitesNorway
- Study dates
- Aug 2014to Dec 2017
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Iso-BMI>25,
- able to participate in activity groups
Who cannot join
- Children being unable to participate in activity groups,
- parents not able to participate in group based and individual counseling
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
University of Bergen
Bergen, Hordaland, 5018
University of Agder
Kristiansand, Vest-Agder, 4604
About this study
Official title: Promoting Health in Healthy Living Centres - a Clinical Study Among Famililies With Overweight Children
The overall aim is to evaluate if a familybased intervention, targeting overweight and obese children and their parents, has a long-term positive effect on weight development and health of the children. The alternative hypothesis to the zero hypothesis is that the children with overweight and obesity who participate in a one-year intervention together with their parents, both at completion of the six months intervention and at long term follow up will have reduced their BMI-for-age z-score (Iso-BMI) and have adopted healthy habits. The behavioral models and educational strategies will be tailored (by age, gender etc.) and include both general information and practical learning sessions.
Read the detailed description
The investigators intend to perform a controlled clinical trial on interventions on a systemic level.
The target group is overweight and obese children between 6 and 10 years old, their parents, community administrators and public health nurses. The overall aim is to evaluate if a familybased intervention, targeting overweight and obese children and their parents, has a long-term positive effect on weight development of the children. The alternative hypothesis to the zero hypothesis is that the children with overweight and obesity who participate with their parents, both at completion of the six months intervention and at long term follow up (2 years) will have reduced their BMI-for-age z-score (Iso-BMI). The behavioral models and educational strategies will be tailored (by age, gender etc.) and include both general information and practical learning sessions. The program will offer guided active play, defined as spontaneous gross locomotor movement in which children engage to amuse and to occupy themselves.
Parents will attend to workshops intending to increase knowledge and awareness of family structure, healthy eating habits and practical suggestions for implementing healthy behaviors into everyday life. Parents will be educated on how to use these strategies at home, to further support their children in improving their behaviors. This community based study is the support by the local leadership and collaboration with locally based sports clubs. The primary outcome variable, child BMI-for-age z-score will be measured at referral, inclusion, after 6 months, and at 1 and 2 years post intervention. Secondary outcome variables, measured at inclusion and at the end of intervention, are child activity pattern, screen viewing time, eating habits, sleeping patterns and body composition as well as parent BMI, body composition, exercise habits, perception of health, experience of parenthood and level of parental stress.
Physical activity level as well as sleep duration and -quality will be recorded using biaxial accellerometers. A validated food diary will be used. The participants will also be asked to complete a questionnaire including questions about screen viewing time, self-perceived healt, sleeping patterns (children) and perceived autonomy support and autonomous regulations (parents).
- Conditions
- Health Behavior
- Being tested
- Activity groups, Group based dietary counselling, Individual counselling
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity groupsBehavioural
Children attend to activity groups weekly during the intervention periode.
Group based dietary counsellingBehavioural
Parents attend to four sessions of group based dietary counselling
Individual counsellingBehavioural
Parents attend to individual counselling focusing on parental skills and family structure
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | The intervention groups start the intervention 6 months ahead of the control group. Receives: Behavioral: Activity groups; Behavioral: Group based dietary counselling; Behavioral: Individual counselling |
| Delayed intervention group | No intervention | The control groups will start intervention with 6 months delay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iso-BMI
Measure change at 6 month controlled study, and at 1 and 2 years to measure long-term effects
Measured: Change at 6 months, 1 year, 2 years
Secondary outcomes (3)
Physical activity level
Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects. We will use SenseWear bi-axial accelerometer to mesa sure physics activity.
Measured: 6 months, 1 and 2 years
Dietary habits
Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects. We will use a specially designed questionnaire to measure dietary habits.
Measured: 6 months, 1 and 2 years
Self-perceived health
Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects. We will use KidScreen 10 questionnaire to measure self-perceived health.
Measured: 6 months, 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2017
- Study completionDec 2017
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 Health BehaviorStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eivind Meland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Agder
- Responsible party
- Sponsor-investigator, Eivind Meland, University of Bergen
- Investigators
- Eivind Meland, MD, PhD, Principal investigator, Dept of Glob Publ Health and Primary Care, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290171
- Sponsor's protocol ID
- NCT02290171
- Status last verified
- Oct 2019
- First submitted
- 26 Oct 2014
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Stea TH, Vettore MV, Ovrebo B, Abildsnes E. Changes in dietary habits and BMI z-score after a 6-month non-randomized cluster-controlled trial among 6-12 years old overweight and obese Norwegian children. Food Nutr Res. 2023 Dec 12;67. doi: 10.29219/fnr.v67.9617. eCollection 2023.
PubMed 38187797
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Health in Healthy Living Centres - a Clinical Study Among Famililies With Overweight Children
- ClinicalTrials.gov ID
- NCT02290171
- Acronym / sponsor ID
- NCT02290171
- Conditions
- Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Eivind MelandUniversity, hospital or other
- Collaborators
- University of Agder
- Study start
- Aug 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 13 Nov 2014 (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 overall aim is to evaluate if a familybased intervention, targeting overweight and obese children and their parents, has a long-term positive effect on weight development and health of the children. The alternative hypothesis to the zero hypothesis is that the children with overweight and obesity who participate in a one-year intervention together with their parents, both at completion of the six months intervention and at long term follow up will have reduced their BMI-for-age z-score (Iso-BMI) and have adopted healthy habits. The behavioral models and educational strategies will be tailored (by age, gender etc.) and include both general information and practical learning sessions.
Detailed description
The investigators intend to perform a controlled clinical trial on interventions on a systemic level.
The target group is overweight and obese children between 6 and 10 years old, their parents, community administrators and public health nurses. The overall aim is to evaluate if a familybased intervention, targeting overweight and obese children and their parents, has a long-term positive effect on weight development of the children. The alternative hypothesis to the zero hypothesis is that the children with overweight and obesity who participate with their parents, both at completion of the six months intervention and at long term follow up (2 years) will have reduced their BMI-for-age z-score (Iso-BMI). The behavioral models and educational strategies will be tailored (by age, gender etc.) and include both general information and practical learning sessions. The program will offer guided active play, defined as spontaneous gross locomotor movement in which children engage to amuse and to occupy themselves.
Parents will attend to workshops intending to increase knowledge and awareness of family structure, healthy eating habits and practical suggestions for implementing healthy behaviors into everyday life. Parents will be educated on how to use these strategies at home, to further support their children in improving their behaviors. This community based study is the support by the local leadership and collaboration with locally based sports clubs. The primary outcome variable, child BMI-for-age z-score will be measured at referral, inclusion, after 6 months, and at 1 and 2 years post intervention. Secondary outcome variables, measured at inclusion and at the end of intervention, are child activity pattern, screen viewing time, eating habits, sleeping patterns and body composition as well as parent BMI, body composition, exercise habits, perception of health, experience of parenthood and level of parental stress.
Physical activity level as well as sleep duration and -quality will be recorded using biaxial accellerometers. A validated food diary will be used. The participants will also be asked to complete a questionnaire including questions about screen viewing time, self-perceived healt, sleeping patterns (children) and perceived autonomy support and autonomous regulations (parents).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: Activity groups, Behavioral: Group based dietary counselling, Behavioral: Individual counsellingThe intervention groups start the intervention 6 months ahead of the control group. |
| Delayed intervention group | No intervention | –The control groups will start intervention with 6 months delay |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Iso-BMI>25,
- able to participate in activity groups
Key exclusion criteria (2 listed)
- Children being unable to participate in activity groups,
- parents not able to participate in group based and individual counseling
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 |
|---|---|---|
| Activity groupsChildren attend to activity groups weekly during the intervention periode. | Behavioural | Intervention group |
| Group based dietary counsellingParents attend to four sessions of group based dietary counselling | Behavioural | Intervention group |
| Individual counsellingParents attend to individual counselling focusing on parental skills and family structure | Behavioural | Intervention group |
Primary outcome
Iso-BMI
Time frame: Change at 6 months, 1 year, 2 years
Measure change at 6 month controlled study, and at 1 and 2 years to measure long-term effects
3 secondary outcomes
Physical activity level
Time frame: 6 months, 1 and 2 years
Dietary habits
Time frame: 6 months, 1 and 2 years
Self-perceived health
Time frame: 6 months, 1 and 2 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 10 Oct 2019.
- Derived from this study: PubMed 38187797Stea TH, Vettore MV, Ovrebo B, Abildsnes E. Changes in dietary habits and BMI z-score after a 6-month non-randomized cluster-controlled trial among 6-12 years old overweight and obese Norwegian children. Food Nutr Res. 2023 Dec 12;67. doi: 10.29219/fnr.v67.9617. eCollection 2023.
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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.
Eivind Meland, MD, PhD principal investigator
Dept of Glob Publ Health and Primary Care, University of Bergen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity groups, Group based dietary counselling and Individual counselling in people with Health Behavior, run by Eivind Meland at 2 sites in Norway.
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 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 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
Iso-BMI (time frame: Change at 6 months, 1 year, 2 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 NCT02290171, 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 10 Oct 2019.