ObesityEarlySTOPPNCT01198847
Early Stockholm Obesity Prevention Program
A study testing Dietary, physical activity and sleeping in people with Obesity and Overweight, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
To study whether a targeted intervention can prevent the development of overweight and obesity among pre-school children in families with either one obese or two overweight parents. Read more about this study
- Who is it for?
- Ages 1 to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Dietary, physical activity and sleeping
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2010to Mar 2019
- 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 1 to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- one obese or two overweight parents, 1 year old child
Who cannot join
- weight effecting diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity
To study whether a targeted intervention can prevent the development of overweight and obesity among pre-school children in families with either one obese or two overweight parents.
Read the detailed description
Early STOPP project wants to promote good health in children from early age by supporting good habits for the whole family. Our aim is to see if we can prevent overweight and obesity in children in families where parents are overweight or obese. Normal weight parents will also be needed in this study.
Background Life is in constant change and affects our habits. In many ways this is positive but it also contributes to less favorable health factors. For example, take the car instead of cycling, take the lift instead of the stairs. This makes us less active in everyday life. Individuals also eat more unhealthy foods in larger portions. In combination with genetics, social in heritage and surrounding factors this contributes to increase overweight and obesity among children not only in adults but also in children.
Good treatment methods for childhood obesity are lacking, making prevention very important. The earlier good habits are introduced to a child the better it is.
In Early STOPP project we study food, physical activity and sleep habits in the families with a little child. The height, weight, waist circumference and blood pressure will be recorded in both child and parents. The parents will answer questionnaires about food, physical activity and sleeping habits for both the child and themselves. During the study, the child's physical activity will be measured.
- Conditions
- Obesity, Overweight
- Being tested
- Dietary, physical activity and sleeping
- Keywords
- child overweight, child obesity, prevention, targeted intervention, development of overweight
- Medical subject headings
- Obesity, Overweight, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary, physical activity and sleepingBehavioural
The intervention in the present study will be delivered through sessions aiming at developing healthy lifestyle habits regarding physical activity, food intake and regular sleeping habits for parents and children. These sessions will be performed face to face by trained health care workers and carried out in the welfare centres with the parent/s. Children will not be approached directly in the present study. All families will meet with their coach/facilitator during at least 12 times (including start and final evaluation meeting) until the children reach 6 years of age (such as school age). However extra effort (as boosting sessions) will be made if growth records show an increased BMI (weight induced meetings). The parents are also encouraged to keep contact with their coach either by phone or e-mail as often as they feel needed.
The Low intensity arm will only receive written information and no direct face to face support
| Study group | Role | What they receive |
|---|---|---|
| Low intensity arm | Active comparator | Written information about a healthy lifestyle Receives: Behavioral: Dietary, physical activity and sleeping |
| High intensity arm | Experimental | Lifestyle support (PA, sleep, food intake) using MI Receives: Behavioral: Dietary, physical activity and sleeping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention
Weight gain, reflected in BMI sds will reflect if the intervention has been successful
Measured: 5 years
Secondary outcomes (5)
sleeping behavior
sleeping duration will be monitored to study its effect on intervention
Measured: 5 years
biomarkers
such as bacterial population in feces, markers in blood and in saliva
Measured: 5 years
physical activity and sedentary behaviour
physical activity and sedentary behavious will be monitored during the intervention
Measured: 5 years
dietary intake
changes in dietary habits and behaviour will be monitored
Measured: 5 years
socioeconomic factors
factors effecting obesity development will be assessed in order to understand their impact on intervention
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2014
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claude Marcus, Karolinska Institutet
- Investigators
- claude marcus, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198847
- Sponsor's protocol ID
- ES-2010
- Acronym
- EarlySTOPP
- Status last verified
- Aug 2019
- First submitted
- 9 Sep 2010
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sobko T, Svensson V, Ek A, Ekstedt M, Karlsson H, Johansson E, Cao Y, Hagstromer M, Marcus C. A randomised controlled trial for overweight and obese parents to prevent childhood obesity--Early STOPP (STockholm Obesity Prevention Program). BMC Public Health. 2011 May 18;11:336. doi: 10.1186/1471-2458-11-336.
PubMed 21592388Bergqvist-Noren L, Hagman E, Xiu L, Marcus C, Hagstromer M. Physical activity in early childhood: a five-year longitudinal analysis of patterns and correlates. Int J Behav Nutr Phys Act. 2022 Apr 20;19(1):47. doi: 10.1186/s12966-022-01289-x.
PubMed 35443696Xiu L, Ekstedt M, Hagstromer M, Bruni O, Bergqvist-Noren L, Marcus C. Sleep and Adiposity in Children From 2 to 6 Years of Age. Pediatrics. 2020 Mar;145(3):e20191420. doi: 10.1542/peds.2019-1420. Epub 2020 Feb 18.
PubMed 32071262Johansson E, Hagstromer M, Svensson V, Ek A, Forssen M, Nero H, Marcus C. Objectively measured physical activity in two-year-old children - levels, patterns and correlates. Int J Behav Nutr Phys Act. 2015 Jan 24;12:3. doi: 10.1186/s12966-015-0161-0.
PubMed 25616495
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity
- ClinicalTrials.gov ID
- NCT01198847
- Acronym / sponsor ID
- EarlySTOPP / ES-2010
- Conditions
- Obesity, Overweight
- Keywords
- child overweight, child obesity, prevention, targeted intervention, development of overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 10 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.
To study whether a targeted intervention can prevent the development of overweight and obesity among pre-school children in families with either one obese or two overweight parents.
Detailed description
Early STOPP project wants to promote good health in children from early age by supporting good habits for the whole family. Our aim is to see if we can prevent overweight and obesity in children in families where parents are overweight or obese. Normal weight parents will also be needed in this study.
Background Life is in constant change and affects our habits. In many ways this is positive but it also contributes to less favorable health factors. For example, take the car instead of cycling, take the lift instead of the stairs. This makes us less active in everyday life. Individuals also eat more unhealthy foods in larger portions. In combination with genetics, social in heritage and surrounding factors this contributes to increase overweight and obesity among children not only in adults but also in children.
Good treatment methods for childhood obesity are lacking, making prevention very important. The earlier good habits are introduced to a child the better it is.
In Early STOPP project we study food, physical activity and sleep habits in the families with a little child. The height, weight, waist circumference and blood pressure will be recorded in both child and parents. The parents will answer questionnaires about food, physical activity and sleeping habits for both the child and themselves. During the study, the child's physical activity will be measured.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low intensity arm | Active comparator | Behavioral: Dietary, physical activity and sleepingWritten information about a healthy lifestyle |
| High intensity arm | Experimental | Behavioral: Dietary, physical activity and sleepingLifestyle support (PA, sleep, food intake) using MI |
Who may qualify
- Ages
- 1 to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- one obese or two overweight parents, 1 year old child
Key exclusion criteria (1 listed)
- weight effecting diseases
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 |
|---|---|---|
| Dietary, physical activity and sleepingThe intervention in the present study will be delivered through sessions aiming at developing healthy lifestyle habits regarding physical activity, food intake and regular sleeping habits for parents and children. These sessions will be performed face to face by trained health care workers and carried out in the welfare centres with the parent/s. Children will not be approached directly in the present study. All families will meet with their coach/facilitator during at least 12 times (including start and final evaluation meeting) until the children reach 6 years of age (such as school age). However extra effort (as boosting sessions) will be made if growth records show an increased BMI (weight induced meetings). The parents are also encouraged to keep contact with their coach either by phone or e-mail as often as they feel needed. The Low intensity arm will only receive written information and no direct face to face support | Behavioural | High intensity arm, Low intensity arm |
Primary outcome
Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention
Time frame: 5 years
Weight gain, reflected in BMI sds will reflect if the intervention has been successful
5 secondary outcomes
sleeping behavior
Time frame: 5 years
biomarkers
Time frame: 5 years
physical activity and sedentary behaviour
Time frame: 5 years
dietary intake
Time frame: 5 years
socioeconomic factors
Time frame: 5 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 14 Aug 2019.
- Background: PubMed 21592388Sobko T, Svensson V, Ek A, Ekstedt M, Karlsson H, Johansson E, Cao Y, Hagstromer M, Marcus C. A randomised controlled trial for overweight and obese parents to prevent childhood obesity--Early STOPP (STockholm Obesity Prevention Program). BMC Public Health. 2011 May 18;11:336. doi: 10.1186/1471-2458-11-336.
- Derived from this study: PubMed 35443696Bergqvist-Noren L, Hagman E, Xiu L, Marcus C, Hagstromer M. Physical activity in early childhood: a five-year longitudinal analysis of patterns and correlates. Int J Behav Nutr Phys Act. 2022 Apr 20;19(1):47. doi: 10.1186/s12966-022-01289-x.
- Derived from this study: PubMed 32071262Xiu L, Ekstedt M, Hagstromer M, Bruni O, Bergqvist-Noren L, Marcus C. Sleep and Adiposity in Children From 2 to 6 Years of Age. Pediatrics. 2020 Mar;145(3):e20191420. doi: 10.1542/peds.2019-1420. Epub 2020 Feb 18.
- Derived from this study: PubMed 25616495Johansson E, Hagstromer M, Svensson V, Ek A, Forssen M, Nero H, Marcus C. Objectively measured physical activity in two-year-old children - levels, patterns and correlates. Int J Behav Nutr Phys Act. 2015 Jan 24;12:3. doi: 10.1186/s12966-015-0161-0.
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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.
claude marcus, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary, physical activity and sleeping in people with Obesity and Overweight, run by Karolinska Institutet 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 1 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 14 Aug 2019. 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 score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (time frame: 5 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 NCT01198847, which also lists 4 linked publications.
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 14 Aug 2019.