Childhood ObesityNCT02794090
Childhood Obesity Treatment - Telephone Coaching vc Usual Care
A study testing Telephone coaching in people with Childhood Obesity, run by Sodertalje Hospital.
Trial summary
This study evaluates if usual physical care visits to an outpatient pediatric clinic can be replaced with more frequent and shorter Telephone coaching Contacts during 18 months. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Telephone coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- May 2007to 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 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 5 to 14 years old who were patients at the outpatient pediatric centre
- All families after that the parents had attended at least 4 of 7 meetings in a parental/education group.
Who cannot join
- Obesity related syndromes
- Non-Swedish speaking families
About this study
Official title: Exclusive Telephone Coaching in Maintaining Weight Loss - An Randomized Controlled Trial of Childhood Obesity Treatment
This study evaluates if usual physical care visits to an outpatient pediatric clinic can be replaced with more frequent and shorter Telephone coaching Contacts during 18 months.
Read the detailed description
In this randomized controlled study, patients at age 5 to 14 and enrolled in obesity treatment, were randomized to either usual care according to regular routine or to telephone consultation.The randomization was done at the start of individual treatment and lasted for 18 months. We also studied working time required for the Health care, and the families' experience of the Telephone coaching.
- Conditions
- Childhood Obesity
- Being tested
- Usual care, individual visits, Telephone coaching
- Keywords
- Behavioral treatment, Telephone coaching, Outpatient clinic
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual care, individual visitsBehavioural
Randomized controlled study of two types of delivering behavioral treatment to Children suffering from obesity.
Telephone coachingBehavioural
Randomized controlled study of two types of delivering behavioral treatment to Children suffering from obesity.
| Study group | Role | What they receive |
|---|---|---|
| Usual care, individual visits | Active comparator | Usual care according to regular treatment routines at the clinic during 18 months. The Child and parent(s) at regular visits to the nurse at the clinic. Receives: Behavioral: Usual care, individual visits |
| Telephone coaching | Active comparator | Intervention: Telephone consultation each months except for summer holidays during 18 months. The treating nurse communicated with one of the parents. Receives: Behavioral: Telephone coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI Standard Deviation Score (units)
BMI Standard Deviation Score units using the Swedish reference by Karlberg et al 2001.
Measured: From start of treatment, during intervention and follow-up. In total mean 3,7 years
Secondary outcomes (2)
Working time required for the Health care personnel
Mean time for each group measured in minutes
Measured: During the intervention 18 months
Families experience of the treatment
Experience for both the Telephone consultation and usual care by not validated anonymous questionnaires constructed by the researchers in this project
Measured: During the intervention 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startMay 2007
- Primary completionSep 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sodertalje Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Pernilla Danielsson, Karolinska Institutet
- Investigators
- Pernilla Danielsson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794090
- Sponsor's protocol ID
- So100
- Status last verified
- Jun 2016
- First submitted
- 31 May 2016
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exclusive Telephone Coaching in Maintaining Weight Loss - An Randomized Controlled Trial of Childhood Obesity Treatment
- ClinicalTrials.gov ID
- NCT02794090
- Acronym / sponsor ID
- So100
- Conditions
- Childhood Obesity
- Keywords
- Behavioral treatment, Telephone coaching, Outpatient clinic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Sodertalje HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- May 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Jun 2016 (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.
This study evaluates if usual physical care visits to an outpatient pediatric clinic can be replaced with more frequent and shorter Telephone coaching Contacts during 18 months.
Detailed description
In this randomized controlled study, patients at age 5 to 14 and enrolled in obesity treatment, were randomized to either usual care according to regular routine or to telephone consultation.The randomization was done at the start of individual treatment and lasted for 18 months. We also studied working time required for the Health care, and the families' experience of the Telephone coaching.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care, individual visits | Active comparator | Behavioral: Usual care, individual visitsUsual care according to regular treatment routines at the clinic during 18 months. The Child and parent(s) at regular visits to the nurse at the clinic. |
| Telephone coaching | Active comparator | Behavioral: Telephone coachingIntervention: Telephone consultation each months except for summer holidays during 18 months. The treating nurse communicated with one of the parents. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children 5 to 14 years old who were patients at the outpatient pediatric centre
- All families after that the parents had attended at least 4 of 7 meetings in a parental/education group.
Key exclusion criteria (2 listed)
- Obesity related syndromes
- Non-Swedish speaking families
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 |
|---|---|---|
| Usual care, individual visitsRandomized controlled study of two types of delivering behavioral treatment to Children suffering from obesity. | Behavioural | Usual care, individual visits |
| Telephone coachingRandomized controlled study of two types of delivering behavioral treatment to Children suffering from obesity. | Behavioural | Telephone coaching |
Primary outcome
Change in BMI Standard Deviation Score (units)
Time frame: From start of treatment, during intervention and follow-up. In total mean 3,7 years
BMI Standard Deviation Score units using the Swedish reference by Karlberg et al 2001.
2 secondary outcomes
Working time required for the Health care personnel
Time frame: During the intervention 18 months
Families experience of the treatment
Time frame: During the intervention 18 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 9 Jun 2016.
- Individual participant dataSharing planned: No
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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.
Pernilla Danielsson, PhD principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A study testing Telephone coaching in people with Childhood Obesity, run by Sodertalje Hospital.
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 9 Jun 2016. 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?
Change in BMI Standard Deviation Score (units) (time frame: From start of treatment, during intervention and follow-up. In total mean 3,7 years). 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 9 Jun 2016.