ObesityNCT00149695
Soft Drink, Milk and Obesity in Chilean Children
A study testing Weekly home delivery of milk products in people with Obesity, run by Boston Children's Hospital at 1 site in Chile.
Trial summary
The primary aim of this randomized controlled trial is to evaluate the effects of replacing habitual consumption of sugar-sweetened soft drinks with milk over 16 weeks. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Weekly home delivery of milk products
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 96 participants
- Where
- 1 siteChile
- Study dates
- Jul 2004to Dec 2005
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female, age 8 to 10 years
- Tanner Stage I
- BMI between 85th and 95th percentiles for age and gender
- Consuming at least 2 servings/day of sugar-sweetened beverages
- Willingness to consume milk instead of sugar-sweetened beverages for 16 weeks
- Able to read Spanish and accurately complete dietary assessments
Who cannot join
- Presence of a serious underlying medical condition
- Taking any medication that affects body weight
- History of lactose intolerance or milk protein allergies
- History of an eating disorder
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim of this randomized controlled trial is to evaluate the effects of replacing habitual consumption of sugar-sweetened soft drinks with milk over 16 weeks.
Read the detailed description
The prevalence of obesity has risen dramatically among children in the U.S. and throughout the world since the 1960s. Many factors are thought to have contributed to the epidemic of pediatric obesity. One factor that has received increasing attention is consumption of sugar-sweetened beverages. Feeding studies suggest physiological mechanisms by which sugar in liquid form may be less satiating than other foods. An observational study found total energy consumption to be greater among children who consume sugar-sweetened beverages compared to non-consumes. Short-term interventional studies report increasing energy intake and body weight in subjects given sugar-sweetened beverages compared to non-caloric beverages. Our preliminary data found that the risk for becoming obese increased by about 60% in middle school children for every additional serving per day of sugar-sweetened beverage consumed. The purpose of the present study is to conduct a 16-week clinical trial involving 96 children ages 8 to 10 years in Chile, a developing nation characterized as undergoing a "nutrition transition." The subjects, selected for current sugar-sweetened soft drink consumption, will be randomly assigned to intervention or control groups. The intervention group will be encouraged to substitute milk products for soft-drinks; to facilitate this dietary change, a variety of milk products will be delivered to subjects' homes on a weekly basis. Clinical endpoints include changes in dietary quality, body weight, adiposity by DEXA-scan and measures of calcium homeostasis.
- Conditions
- Obesity
- Being tested
- Weekly home delivery of milk products
- Keywords
- Obesity, beverages, weight loss, body mass index, diet
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly home delivery of milk productsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percent body fat by DXA scan
Secondary outcomes (4)
Body mass index
Blood glucose
Blood insulin
Serum lipids
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJul 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Single blind
- Enrolment
- 96 participants
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Charles H. Hood Foundation
- Investigators
- David S Ludwig, MD, PhD, Principal investigator, Boston Children's HospitalCecilia Albala, MD, Principal investigator, INTA - University of ChileCara B Ebbeling, PhD, Study director, Boston Children's HospitalMariana Cifuentes, PhD, Study director, INTA - University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149695
- Sponsor's protocol ID
- TW006818-Fogarty (completed)
- Other IDs
- R03TW006818
- Status last verified
- Aug 2010
- First submitted
- 31 Aug 2005
- Last updated
- 24 Aug 2010
- Results posted
- No
Publications
Ludwig DS, Peterson KE, Gortmaker SL. Relation between consumption of sugar-sweetened drinks and childhood obesity: a prospective, observational analysis. Lancet. 2001 Feb 17;357(9255):505-8. doi: 10.1016/S0140-6736(00)04041-1.
PubMed 11229668Pereira MA, Jacobs DR Jr, Van Horn L, Slattery ML, Kartashov AI, Ludwig DS. Dairy consumption, obesity, and the insulin resistance syndrome in young adults: the CARDIA Study. JAMA. 2002 Apr 24;287(16):2081-9. doi: 10.1001/jama.287.16.2081.
PubMed 11966382Albala C, Ebbeling CB, Cifuentes M, Lera L, Bustos N, Ludwig DS. Effects of replacing the habitual consumption of sugar-sweetened beverages with milk in Chilean children. Am J Clin Nutr. 2008 Sep;88(3):605-11. doi: 10.1093/ajcn/88.3.605.
PubMed 18779274
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Drink, Milk and Obesity in Chilean Children
- ClinicalTrials.gov ID
- NCT00149695
- Acronym / sponsor ID
- TW006818-Fogarty (completed)
- Conditions
- Obesity
- Keywords
- Obesity, beverages, weight loss, body mass index, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Charles H. Hood Foundation
- Study start
- Jul 2004
- Study completion
- Dec 2005 (actual)
- First posted
- 8 Sep 2005 (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 primary aim of this randomized controlled trial is to evaluate the effects of replacing habitual consumption of sugar-sweetened soft drinks with milk over 16 weeks.
Detailed description
The prevalence of obesity has risen dramatically among children in the U.S. and throughout the world since the 1960s. Many factors are thought to have contributed to the epidemic of pediatric obesity. One factor that has received increasing attention is consumption of sugar-sweetened beverages. Feeding studies suggest physiological mechanisms by which sugar in liquid form may be less satiating than other foods. An observational study found total energy consumption to be greater among children who consume sugar-sweetened beverages compared to non-consumes. Short-term interventional studies report increasing energy intake and body weight in subjects given sugar-sweetened beverages compared to non-caloric beverages. Our preliminary data found that the risk for becoming obese increased by about 60% in middle school children for every additional serving per day of sugar-sweetened beverage consumed. The purpose of the present study is to conduct a 16-week clinical trial involving 96 children ages 8 to 10 years in Chile, a developing nation characterized as undergoing a "nutrition transition." The subjects, selected for current sugar-sweetened soft drink consumption, will be randomly assigned to intervention or control groups. The intervention group will be encouraged to substitute milk products for soft-drinks; to facilitate this dietary change, a variety of milk products will be delivered to subjects' homes on a weekly basis. Clinical endpoints include changes in dietary quality, body weight, adiposity by DEXA-scan and measures of calcium homeostasis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female, age 8 to 10 years
- Tanner Stage I
- BMI between 85th and 95th percentiles for age and gender
- Consuming at least 2 servings/day of sugar-sweetened beverages
- Willingness to consume milk instead of sugar-sweetened beverages for 16 weeks
Key exclusion criteria (4 listed)
- Presence of a serious underlying medical condition
- Taking any medication that affects body weight
- History of lactose intolerance or milk protein allergies
- History of an eating disorder
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 |
|---|---|---|
| Weekly home delivery of milk products | Behavioural | – |
Primary outcome
Change in percent body fat by DXA scan
4 secondary outcomes
Body mass index
Blood glucose
Blood insulin
Serum lipids
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 24 Aug 2010.
- Background: PubMed 11229668Ludwig DS, Peterson KE, Gortmaker SL. Relation between consumption of sugar-sweetened drinks and childhood obesity: a prospective, observational analysis. Lancet. 2001 Feb 17;357(9255):505-8. doi: 10.1016/S0140-6736(00)04041-1.
- Background: PubMed 11966382Pereira MA, Jacobs DR Jr, Van Horn L, Slattery ML, Kartashov AI, Ludwig DS. Dairy consumption, obesity, and the insulin resistance syndrome in young adults: the CARDIA Study. JAMA. 2002 Apr 24;287(16):2081-9. doi: 10.1001/jama.287.16.2081.
- Derived from this study: PubMed 18779274Albala C, Ebbeling CB, Cifuentes M, Lera L, Bustos N, Ludwig DS. Effects of replacing the habitual consumption of sugar-sweetened beverages with milk in Chilean children. Am J Clin Nutr. 2008 Sep;88(3):605-11. doi: 10.1093/ajcn/88.3.605.
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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.
David S Ludwig, MD, PhD principal investigator
Boston Children's Hospital
Cecilia Albala, MD principal investigator
INTA - University of Chile
Cara B Ebbeling, PhD study director
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly home delivery of milk products in people with Obesity, run by Boston Children's Hospital at 1 site in Chile.
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 6 inclusion and 4 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 24 Aug 2010. 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 Chile. 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?
Change in percent body fat by DXA scan. 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 NCT00149695, which also lists 3 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 24 Aug 2010.