OverweightNCT01583335
The Healthy Start Project: Primary Prevention of Overweight in Preschool Children Susceptible to Future Overweight
A study testing Lifestyle habits, including sleep and stress in people with Overweight and Obesity, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Obesity prevention should remain a priority, although there is some evidence of a possible leveling off in some age groups across European countries and in USA, Japan and Australia. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Lifestyle habits, including sleep and stress
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,202 participants
- Where
- 1 siteDenmark
- Study dates
- May 2009to Jun 2018
- 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 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Born between 2004-2007
- Born in 11 selected municipalities in the greater Copenhagen area
- Classified as susceptible to overweight and obesity (At least one of the following risk factors present: A high birth weight (> 4000 grams), maternal pre-pregnancy obesity (BMI > 28 kg/m^2), or maternal low education (<= 10 years)
- Normal weight at baseline examination
Who cannot join
- Moved to another municipality after birth,
- Had requested protection from participation in statistical or scientific surveys based on data delivered from the Danish Central Person Registry
- No permanent address
- Lived in a children's home
- Had died
- Had emigrated
Show all 9Show fewer
- Registered in the Danish Central Person Registry as being disappeared or had unknown life status
- Not speaking Danish
- Overweight (including obesity) at baseline examination
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Parker Institute, Research Unit for Dietary Studies
Frederiksberg, 2000
About this study
Official title: Prevention of Weight Gain Among Normal Weight, Obesity Susceptible, Pre-school Children - a Randomized Controlled Interventions Study.
Obesity prevention should remain a priority, although there is some evidence of a possible leveling off in some age groups across European countries and in USA, Japan and Australia. Besides adult health problems such as type-2 diabetes and cardiovascular diseases, obesity in childhood is associated with psychological and social problems, low self-esteem, stigmatization and being teased and bullied by friends. Danish research suggests that the causes behind the increase in obesity occurrence are present already in early childhood, and that prevention of obesity therefore has to start early. Research has suggested that at least three sub-groups can be considered susceptible to develop obesity: Children with obesity among their 1st degree relatives; children with a high birth weight or children coming from socially disadvantaged families (low socioeconomic status). Earlier intervention programs has showed little effect in preventing excessive weight gain and knowledge on how to develop effective intervention programs that reduce overweight and obesity remains limited. It has been suggested that future prevention programs may be more successful if specifically targeting groups that are at high risk, as mention above, of excessive weight gain.
Based on these suggestions, the "Sund Start" project was initiated. The purpose of the study was to determine whether aiming prevention towards 2-6 years old Danish children who were yet normal weight, but were considered susceptible to develop overweight or obese could prevent later on risk of becoming overweight or obese. Furthermore, to investigate if it was possible to improve diet habits, increase physical activity, reduce stress and improve sleeping habits among children at high risk for later on overweight and obesity.
The "Sund Start" project will contribute with knowledge about whether targeting normal weight, predisposed children is effective in preventing overweight and obesity, and if reduced stress and improved sleep, should be considered important new obesity prevention tools. Moreover, the project will contribute with knowledge about how to change lifestyle and its effects on development of overweight and obesity in high risk Danish preschool children.
Read the detailed description
In 2009, data on all births between 2004 and 2007 in 11 selected municipalities from the greater Copenhagen area was obtained from the Danish national birth register at the National Board of Health. This register contains information on all births, whether at hospital or home, on factors such as birth weight and length, height and pre-pregnant weight of the mother, parity, and Central Personal Registry number (CPR-number). Data on socioeconomic status was obtained from the administrative birth forms. This was done manually using the CPR-numbers obtained from the birth register.
After selection of the children eligible for participation, the children were allocated to three groups, (intervention group, control group, shadow group) using computer based randomization. All siblings were allocated to the same group. After the random allocation, children from the intervention group and the control group were sent a letter with an invitation to participate in the project. Children from the shadow group were also identified, and their general practitioners were contacted and asked for information on each child's height and weight.
- Conditions
- Overweight, Obesity
- Being tested
- Lifestyle habits, including sleep and stress
- Keywords
- Overweight, Obesity, Susceptibility, Prevention, Diet, Physical activity, Sleep, Family stress
- Medical subject headings
- Overweight, Obesity, Disease Susceptibility, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle habits, including sleep and stressBehavioural
The intervention group was offered up to 10 individual consultations focusing on improving diet, physical activity and sleep habits and reducing stress. Moreover, the intervention group was offered participation in monthly cooking classes and playing arrangements
| Study group | Role | What they receive |
|---|---|---|
| Improved lifestyle | Experimental | Not described Receives: Behavioral: Lifestyle habits, including sleep and stress |
| Control group | No intervention | The control group was seen at baseline and follow-up, but not in between. |
| Shadow group | No intervention | The shadow group was followed in registers exclusively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric measurements
Changes between baseline and 1.3 years follow.up per intervention year in:
Height in cm Weight in kg BMI in kg/m^2 BMI z-score in SD Waist circumference in cm Hip circumference in cm Sum of four skinfolds (biceps, triceps, subscapular and suprailiac) in cm Body composition measured by bio-electrical impedance
Measured: 1.3 years
Anthropometric measurements
Changes between baseline and 5 years follow.up per intervention year in:
Height in cm Weight in kg BMI in kg/m^2 BMI z-score in SD
Measured: 5 years
Anthropometric measurements
Changes between baseline and 10 years follow.up per intervention year in:
Height in cm Weight in kg BMI in kg/m^2 BMI z-score in SD
Measured: 10 years
Secondary outcomes (25)
Dietary intake
Four day dietary record completed Wednesday-Saturday
Measured: 1.3 years
Priority of serving fruit and vegetables
How high do you prioritize that fruit and vegetables are served at the meals? (Scale from 1 to 4, 1 being low and 4 being high. Higher values considered better outcome)
Measured: 1.3 years
Physical activity
Children's Physical Activity Questionnaire (C-PAQ. 7-day recording of sports, games and leisure time activities outside daycare. The response options were indicated by doing a particular activity ("yes" or "no") and by an indication of total time used on the activity during the week (minutes per week). All minutes per week were summed to obtain an indication of overall physical activity level. Higher values considered better outcome)
Measured: 1.3 years
Sleep duration
7 day sleep record from completed questionnaire (average number of minutes sleep summed from 7 day record on sleep- and wake time points)
Measured: 1.3 years
Child stress level
Measured concentration of cortisol in hair samples
Measured: 1.3 years
Parental stress level
Measured concentration of cortisol in hair samples
Measured: 1.3 year
Sleep quality
Child's sleep is considered (calm all night, a little disturbed, disturbed with occasional awakenings, very disturbed with several awakenings. Calm all night considered best outcome).
Measured: 1.3 year
Child stress level
Strengths and Difficulties Questionnaire (SDQ). Scored 0-2 and summed to Total Difficulties score (0-40, lower score indicate better outcome), and Prosocial Behavior score (0-10, lower score indicate worst outcome)
Measured: 1.3 year
Parental stress level
Modified version of the Swedish Parental Stress Index (PSI). Each question was scored between 0 and 2 (0 considered best score and 2 the worst), according to its estimated indication of an overall stress level. Analysis of intercorrelations among the 10 questions and a principal component analysis suggested that 9 of the 10 questions could be added together to get a score for the overall family stress level (0-18)
Measured: 1.3 years
Daily physical activity: Enjoys being active
If the child enjoyed being physically active (Never, often, some times, usually, always. Always considered best outcome)
Measured: 1.3 years
Meal habits: Eating breakfast together
How many times per week does the family eat breakfast together (None, 1 day, 2-3 days, 4-5 days, 6-7 days. 6-7 days considered best outcome).
Measured: 1.3 years
Meal habits: Eating dinner together
How many times per week does the family eat dinner together (None, 1 day, 2-3 days, 4-5 days, 6-7 days. 6-7 days considered best outcome).
Measured: 1.3 years
Meal habits: Mealtime situation
How would you describe the meals with the child (Very conflictive, little conflictive, very cozy, little cozy, don't know. Very cozy considered best outcome).
Measured: 1.3 years
Meal habits: Pickiness
How would you describe your child's way of eating (Picky, open to new tastes, eats everything. Eats everything considered best outcome).
Measured: 1.3 years
Meal habits: Appetite
How would you describe your child's appetite (Too big appetite, good appetite, normal appetite, too small appetite, don't know. Normal appetite considered best outcome).
Measured: 1.3 years
Sleep quality: Difficulties falling asleep
Difficulties falling asleep (yes/no. No considered best outcome)
Measured: 1.3 years
Sleep quality: Difficulties waking up
Difficulties waking up (yes/no. No considered best outcome)
Measured: 1.3 years
Sleep quality: Sleep onset latency
Sleep onset latency (numerical. Lower values considered better outcome)
Measured: 1.3 years
Sleep quality: Bedtime routines
Routine activities before bedtime (No, < 1/week, 1-2 times/week, 3-4 times/week, 5-6 times/week, every day. Every day considered best outcome)
Measured: 1.3 years
Sleep quality: Joining parents' bed
Child joining parents' bed (yes/no. If yes, how often (< 1/month, 1-3 times/month,1-3 times/week, 4-6 times/week, every night)
Measured: 1.3 years
Sleep quality: Falling asleep
Child afraid to fall asleep (Never, rarely, some times, often, very often. Never considered best outcome)
Measured: 1.3 years
Sleep quality: Dreams
Child has frightening/upsetting dreams (Never, rarely, some times, often, very often. Never considered best outcome)
Measured: 1.3 years
Daily physical activity: Means of transportation
Means of transportation to and from day-care, and frequency (Walk, strolling, bike on its own, biked by parent, and bus, train or car, number of times per week (1,2,3,4 or 5. Walking or biking on its own considered best outcome).
Measured: 1.3 years
Daily physical activity: Activity compared to other children
How active is the child compared to other children at similar age? (as active, somewhat active, very active, don't know. Very active considered best outcome)
Measured: 1.3 years
Daily physical activity: Activity with parents
Frequency of which one or both parents were physically active with the child (once per week, 2-4 times per week, 5-7 times per week, multiple times per day. Multiple times per day considered best outcome)
Measured: 1.3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startMay 2009
- Primary completionAug 2012
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Participant
- Enrolment
- 1,202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark, The Danish Medical Research Council, Sygekassernes Helsefond
- Responsible party
- Principal investigator, Berit Lilienthal Heitmann, Bispebjerg Hospital
- Investigators
- Berit L Heitmann, Professor, Study director, Parker Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583335
- Sponsor's protocol ID
- Tryg-7984-07
- Status last verified
- May 2020
- First submitted
- 31 Mar 2012
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Rohde JF, Larsen SC, Handel MN, Olsen NJ, Stougaard M, Heitmann BL. Associations between Parental Stress and Subsequent Changes in Dietary Intake and Quality among Preschool Children Susceptible to Obesity. Int J Environ Res Public Health. 2021 Mar 30;18(7):3590. doi: 10.3390/ijerph18073590.
PubMed 33808371Zheng M, Rangan A, Olsen NJ, Heitmann BL. Longitudinal association of nighttime sleep duration with emotional and behavioral problems in early childhood: results from the Danish Healthy Start Study. Sleep. 2021 Jan 21;44(1):zsaa138. doi: 10.1093/sleep/zsaa138.
PubMed 32691048Olsen NJ, Rohde JF, Handel MN, Stougaard M, Mortensen EL, Heitmann BL. Joining Parents' Bed at Night and Overweight among 2- to 6-Year-Old Children - Results from the 'Healthy Start' Randomized Intervention. Obes Facts. 2018;11(5):372-380. doi: 10.1159/000492003. Epub 2018 Oct 12.
PubMed 30308484Handel MN, Larsen SC, Rohde JF, Stougaard M, Olsen NJ, Heitmann BL. Effects of the Healthy Start randomized intervention trial on physical activity among normal weight preschool children predisposed to overweight and obesity. PLoS One. 2017 Oct 9;12(10):e0185266. doi: 10.1371/journal.pone.0185266. eCollection 2017.
PubMed 28991907Olsen NJ, Buch-Andersen T, Handel MN, Ostergaard LM, Pedersen J, Seeger C, Stougaard M, Traerup M, Livemore K, Mortensen EL, Holst C, Heitmann BL. The Healthy Start project: a randomized, controlled intervention to prevent overweight among normal weight, preschool children at high risk of future overweight. BMC Public Health. 2012 Aug 1;12:590. doi: 10.1186/1471-2458-12-590.
PubMed 22852799
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Weight Gain Among Normal Weight, Obesity Susceptible, Pre-school Children - a Randomized Controlled Interventions Study.
- ClinicalTrials.gov ID
- NCT01583335
- Acronym / sponsor ID
- Tryg-7984-07
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obesity, Susceptibility, Prevention, Diet, Physical activity, Sleep, Family stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,202 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark, The Danish Medical Research Council, Sygekassernes Helsefond
- Study start
- May 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 24 Apr 2012 (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.
Obesity prevention should remain a priority, although there is some evidence of a possible leveling off in some age groups across European countries and in USA, Japan and Australia. Besides adult health problems such as type-2 diabetes and cardiovascular diseases, obesity in childhood is associated with psychological and social problems, low self-esteem, stigmatization and being teased and bullied by friends. Danish research suggests that the causes behind the increase in obesity occurrence are present already in early childhood, and that prevention of obesity therefore has to start early. Research has suggested that at least three sub-groups can be considered susceptible to develop obesity: Children with obesity among their 1st degree relatives; children with a high birth weight or children coming from socially disadvantaged families (low socioeconomic status). Earlier intervention programs has showed little effect in preventing excessive weight gain and knowledge on how to develop effective intervention programs that reduce overweight and obesity remains limited. It has been suggested that future prevention programs may be more successful if specifically targeting groups that are at high risk, as mention above, of excessive weight gain.
Based on these suggestions, the "Sund Start" project was initiated. The purpose of the study was to determine whether aiming prevention towards 2-6 years old Danish children who were yet normal weight, but were considered susceptible to develop overweight or obese could prevent later on risk of becoming overweight or obese. Furthermore, to investigate if it was possible to improve diet habits, increase physical activity, reduce stress and improve sleeping habits among children at high risk for later on overweight and obesity.
The "Sund Start" project will contribute with knowledge about whether targeting normal weight, predisposed children is effective in preventing overweight and obesity, and if reduced stress and improved sleep, should be considered important new obesity prevention tools. Moreover, the project will contribute with knowledge about how to change lifestyle and its effects on development of overweight and obesity in high risk Danish preschool children.
Detailed description
In 2009, data on all births between 2004 and 2007 in 11 selected municipalities from the greater Copenhagen area was obtained from the Danish national birth register at the National Board of Health. This register contains information on all births, whether at hospital or home, on factors such as birth weight and length, height and pre-pregnant weight of the mother, parity, and Central Personal Registry number (CPR-number). Data on socioeconomic status was obtained from the administrative birth forms. This was done manually using the CPR-numbers obtained from the birth register.
After selection of the children eligible for participation, the children were allocated to three groups, (intervention group, control group, shadow group) using computer based randomization. All siblings were allocated to the same group. After the random allocation, children from the intervention group and the control group were sent a letter with an invitation to participate in the project. Children from the shadow group were also identified, and their general practitioners were contacted and asked for information on each child's height and weight.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Improved lifestyle | Experimental | Behavioral: Lifestyle habits, including sleep and stress |
| Control group | No intervention | –The control group was seen at baseline and follow-up, but not in between. |
| Shadow group | No intervention | –The shadow group was followed in registers exclusively |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Born between 2004-2007
- Born in 11 selected municipalities in the greater Copenhagen area
- Classified as susceptible to overweight and obesity (At least one of the following risk factors present: A high birth weight (> 4000 grams), maternal pre-pregnancy obesity (BMI > 28 kg/m^2), or maternal low education (<= 10 years)
- Normal weight at baseline examination
Key exclusion criteria (9 listed)
- Moved to another municipality after birth,
- Had requested protection from participation in statistical or scientific surveys based on data delivered from the Danish Central Person Registry
- No permanent address
- Lived in a children's home
- Had died
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 |
|---|---|---|
| Lifestyle habits, including sleep and stressThe intervention group was offered up to 10 individual consultations focusing on improving diet, physical activity and sleep habits and reducing stress. Moreover, the intervention group was offered participation in monthly cooking classes and playing arrangements | Behavioural | Improved lifestyle |
Primary outcome
Anthropometric measurements
Time frame: 1.3 years
Changes between baseline and 1.3 years follow.up per intervention year in: Height in cm Weight in kg BMI in kg/m^2 BMI z-score in SD Waist circumference in cm Hip circumference in cm Sum of four skinfolds (biceps, triceps, subscapular and suprailiac) in cm Body composition measured by bio-electrical impedance
Anthropometric measurements
Time frame: 5 years
Changes between baseline and 5 years follow.up per intervention year in: Height in cm Weight in kg BMI in kg/m^2 BMI z-score in SD
Anthropometric measurements
Time frame: 10 years
Changes between baseline and 10 years follow.up per intervention year in: Height in cm Weight in kg BMI in kg/m^2 BMI z-score in SD
25 secondary outcomes
Dietary intake
Time frame: 1.3 years
Priority of serving fruit and vegetables
Time frame: 1.3 years
Physical activity
Time frame: 1.3 years
Sleep duration
Time frame: 1.3 years
Child stress level
Time frame: 1.3 years
Parental stress level
Time frame: 1.3 year
Sleep quality
Time frame: 1.3 year
Child stress level
Time frame: 1.3 year
Parental stress level
Time frame: 1.3 years
Daily physical activity: Enjoys being active
Time frame: 1.3 years
Meal habits: Eating breakfast together
Time frame: 1.3 years
Meal habits: Eating dinner together
Time frame: 1.3 years
Meal habits: Mealtime situation
Time frame: 1.3 years
Meal habits: Pickiness
Time frame: 1.3 years
Meal habits: Appetite
Time frame: 1.3 years
Sleep quality: Difficulties falling asleep
Time frame: 1.3 years
Sleep quality: Difficulties waking up
Time frame: 1.3 years
Sleep quality: Sleep onset latency
Time frame: 1.3 years
Sleep quality: Bedtime routines
Time frame: 1.3 years
Sleep quality: Joining parents' bed
Time frame: 1.3 years
Sleep quality: Falling asleep
Time frame: 1.3 years
Sleep quality: Dreams
Time frame: 1.3 years
Daily physical activity: Means of transportation
Time frame: 1.3 years
Daily physical activity: Activity compared to other children
Time frame: 1.3 years
Daily physical activity: Activity with parents
Time frame: 1.3 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 15 May 2020.
- Derived from this study: PubMed 33808371Rohde JF, Larsen SC, Handel MN, Olsen NJ, Stougaard M, Heitmann BL. Associations between Parental Stress and Subsequent Changes in Dietary Intake and Quality among Preschool Children Susceptible to Obesity. Int J Environ Res Public Health. 2021 Mar 30;18(7):3590. doi: 10.3390/ijerph18073590.
- Derived from this study: PubMed 32691048Zheng M, Rangan A, Olsen NJ, Heitmann BL. Longitudinal association of nighttime sleep duration with emotional and behavioral problems in early childhood: results from the Danish Healthy Start Study. Sleep. 2021 Jan 21;44(1):zsaa138. doi: 10.1093/sleep/zsaa138.
- Derived from this study: PubMed 30308484Olsen NJ, Rohde JF, Handel MN, Stougaard M, Mortensen EL, Heitmann BL. Joining Parents' Bed at Night and Overweight among 2- to 6-Year-Old Children - Results from the 'Healthy Start' Randomized Intervention. Obes Facts. 2018;11(5):372-380. doi: 10.1159/000492003. Epub 2018 Oct 12.
- Derived from this study: PubMed 28991907Handel MN, Larsen SC, Rohde JF, Stougaard M, Olsen NJ, Heitmann BL. Effects of the Healthy Start randomized intervention trial on physical activity among normal weight preschool children predisposed to overweight and obesity. PLoS One. 2017 Oct 9;12(10):e0185266. doi: 10.1371/journal.pone.0185266. eCollection 2017.
- Derived from this study: PubMed 22852799Olsen NJ, Buch-Andersen T, Handel MN, Ostergaard LM, Pedersen J, Seeger C, Stougaard M, Traerup M, Livemore K, Mortensen EL, Holst C, Heitmann BL. The Healthy Start project: a randomized, controlled intervention to prevent overweight among normal weight, preschool children at high risk of future overweight. BMC Public Health. 2012 Aug 1;12:590. doi: 10.1186/1471-2458-12-590.
- Click here for latest information about the "Sund Start" study.Link provided by the sponsor.
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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.
Berit L Heitmann, Professor study director
Parker Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle habits, including sleep and stress in people with Overweight and Obesity, run by Bispebjerg Hospital at 1 site in Denmark.
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 4 inclusion and 9 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 15 May 2020. 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 Denmark. 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?
Anthropometric measurements (time frame: 1.3 years). The study lists 3 primary outcomes in all. 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 NCT01583335, which also lists 5 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 15 May 2020.