ObesityNCT01662570
Beverage Choice and Lifestyle Modification in Overweight Youth
A study testing Beverage Choice and Lifestyle Modification and Nutrition Education (NE) in people with Obesity, run by University of Pennsylvania at 1 site in United States.
Trial summary
The rise in childhood overweightness and concomitant increase in chronic disease risk warrants exploration into the effectiveness of interventions targeting the eating and activity habits of overweight youth. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Beverage Choice and Lifestyle Modification and Nutrition Education (NE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jan 2011
- 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ages 4-8 years old
- BMI≥85th percentile (based on age and sex)
- consumes large (≥16 oz.day) sugar sweetened beverages
Who cannot join
- Child has a serious medical condition
- Signs of elevated psychopathology are present, as assessed by the Child Behavior Checklist (CBCL)
- Parent demonstrates elevated psychiatric problems or eating disorders
- Failure of parent or child to meet BMI criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, 19104
About this study
The rise in childhood overweightness and concomitant increase in chronic disease risk warrants exploration into the effectiveness of interventions targeting the eating and activity habits of overweight youth. This research study developed and tested a "Beverage Choice and Lifestyle Modification" (BCLM) intervention for 4 to 8 year old children who are at-risk for being overweight or are overweight and who consume large amounts of sugar sweetened beverages and juice. The overall study objectives were to test the acceptability and effectiveness of the BCLM intervention for improving the weight status, energy (kcal) intake, beverage selections and beverage preferences of children in targeted age and BMI group. The investigators hypothesized that those children randomized to the BCLM group will show greater improvements in weight and Body Mass Index (BMI) status, beverage choices,and energy intake than those assigned to our Nutrition Education (NE) group.
- Conditions
- Obesity
- Being tested
- Beverage Choice and Lifestyle Modification, Nutrition Education (NE)
- Keywords
- Pediatric Obesity, Child Overweight
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beverage Choice and Lifestyle ModificationBehavioural
The family-based BCLM intervention trained children and parents in self monitoring of sugar sweetened beverage intake and goal-setting, incorporated feedback and reinforcement, and provided water bottles and water filters to promote a reduction in sugar sweetened beverages and overall energy intake. 16 sessions were provided over a 6-month period.
Nutrition Education (NE)Other
Also called NE
This treatment for parents and children addressed a variety of topics in nutrition including benefits of fruits and vegetables, the food pyramid, vitamins, benefits of eating a variety of foods, and healthy beverage selections. No behavioral change training component was included. 16 sessions over 24 weeks was provided.
| Study group | Role | What they receive |
|---|---|---|
| Beverage Choice Lifestyle Modification | Active comparator | The family-based BCLM intervention trained children and parents in self monitoring of sugar sweetened beverage intake and goal-setting, incorporated feedback and reinforcement, and provided water bottles and water filters to promote a reduction in sugar sweetened beverages and overall energy intake. Receives: Behavioral: Beverage Choice and Lifestyle Modification |
| Nutrition Education (NE) | Other | This treatment for parents and children addressed a variety of topics in nutrition including benefits of fruits and vegetables, the food pyramid, vitamins, benefits of eating a variety of foods, and healthy beverage selections. No behavioral change training component was included. Receives: Other: Nutrition Education (NE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
Change in BMI will be measured from baseline to end of treatment (month 6).
Measured: Baseline and Month 6
Body Mass Index z-score (BMI-z)
Change in BMI-z will be measured from baseline to end of treatment (month 6).
Measured: Baseline and month 6
Body Mass Index Percentile (BMI%)
Change in BMI% will be measured from baseline to end of treatment (month 6).
Measured: Baseline and Month 6
Child percent overweight
Change in child percent overweight will be measured from baseline to end of treatment (month 6).
Measured: Baseline and Month 6
Waist Circumference
Change in waist circumference will be measured from baseline to end of treatment (month 6).
Measured: Baseline to Month 6
Energy (kcal) intake
Change in energy intake (kcals/day) will be measured from baseline to end of treatment (month 6) using 3-day food diaries.
Measured: Baseline to Month 6
Sugar-sweetened beverage intake
Change in sugar-sweetened beverage intake will be measured from baseline to end of treatment (month 6).
Measured: Baseline to Month 6
Treatment acceptance and satisfaction
Overall treatment acceptance and satisfaction will be measured at end of treatment.
Measured: Month 6
Secondary outcomes (1)
Child preferences and motivation for sugar-sweetened beverages
Change in child preference and motivation for sugar-sweetened beverages will be measured from baseline to month 6 using a computerized behavioral choice task assessment.
Measured: Baseline and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startMar 2008
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Myles S Faith, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662570
- Sponsor's protocol ID
- 807775
- Other IDs
- R21DK079075
- Status last verified
- Nov 2011
- First submitted
- 7 Aug 2012
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beverage Choice and Lifestyle Modification in Overweight Youth
- ClinicalTrials.gov ID
- NCT01662570
- Acronym / sponsor ID
- 807775
- Conditions
- Obesity
- Keywords
- Pediatric Obesity, Child Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 10 Aug 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.
The rise in childhood overweightness and concomitant increase in chronic disease risk warrants exploration into the effectiveness of interventions targeting the eating and activity habits of overweight youth. This research study developed and tested a "Beverage Choice and Lifestyle Modification" (BCLM) intervention for 4 to 8 year old children who are at-risk for being overweight or are overweight and who consume large amounts of sugar sweetened beverages and juice. The overall study objectives were to test the acceptability and effectiveness of the BCLM intervention for improving the weight status, energy (kcal) intake, beverage selections and beverage preferences of children in targeted age and BMI group. The investigators hypothesized that those children randomized to the BCLM group will show greater improvements in weight and Body Mass Index (BMI) status, beverage choices,and energy intake than those assigned to our Nutrition Education (NE) group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beverage Choice Lifestyle Modification | Active comparator | Behavioral: Beverage Choice and Lifestyle ModificationThe family-based BCLM intervention trained children and parents in self monitoring of sugar sweetened beverage intake and goal-setting, incorporated feedback and reinforcement, and provided water bottles and water filters to promote a reduction in sugar sweetened beverages and overall energy intake. |
| Nutrition Education (NE) | Other | Other: Nutrition Education (NE)This treatment for parents and children addressed a variety of topics in nutrition including benefits of fruits and vegetables, the food pyramid, vitamins, benefits of eating a variety of foods, and healthy beverage selections. No behavioral change training component was included. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Ages 4-8 years old
- BMI≥85th percentile (based on age and sex)
- consumes large (≥16 oz.day) sugar sweetened beverages
Key exclusion criteria (4 listed)
- Child has a serious medical condition
- Signs of elevated psychopathology are present, as assessed by the Child Behavior Checklist (CBCL)
- Parent demonstrates elevated psychiatric problems or eating disorders
- Failure of parent or child to meet BMI criteria
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 |
|---|---|---|
| Beverage Choice and Lifestyle ModificationThe family-based BCLM intervention trained children and parents in self monitoring of sugar sweetened beverage intake and goal-setting, incorporated feedback and reinforcement, and provided water bottles and water filters to promote a reduction in sugar sweetened beverages and overall energy intake. 16 sessions were provided over a 6-month period. | Behavioural | Beverage Choice Lifestyle Modification |
| Nutrition Education (NE)Also: NEThis treatment for parents and children addressed a variety of topics in nutrition including benefits of fruits and vegetables, the food pyramid, vitamins, benefits of eating a variety of foods, and healthy beverage selections. No behavioral change training component was included. 16 sessions over 24 weeks was provided. | Other | Nutrition Education (NE) |
Primary outcome
Body Mass Index (BMI)
Time frame: Baseline and Month 6
Change in BMI will be measured from baseline to end of treatment (month 6).
Body Mass Index z-score (BMI-z)
Time frame: Baseline and month 6
Change in BMI-z will be measured from baseline to end of treatment (month 6).
Body Mass Index Percentile (BMI%)
Time frame: Baseline and Month 6
Change in BMI% will be measured from baseline to end of treatment (month 6).
Child percent overweight
Time frame: Baseline and Month 6
Change in child percent overweight will be measured from baseline to end of treatment (month 6).
Waist Circumference
Time frame: Baseline to Month 6
Change in waist circumference will be measured from baseline to end of treatment (month 6).
Energy (kcal) intake
Time frame: Baseline to Month 6
Change in energy intake (kcals/day) will be measured from baseline to end of treatment (month 6) using 3-day food diaries.
Sugar-sweetened beverage intake
Time frame: Baseline to Month 6
Change in sugar-sweetened beverage intake will be measured from baseline to end of treatment (month 6).
Treatment acceptance and satisfaction
Time frame: Month 6
Overall treatment acceptance and satisfaction will be measured at end of treatment.
1 secondary outcome
Child preferences and motivation for sugar-sweetened beverages
Time frame: Baseline and Month 6
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 Aug 2012.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Myles S Faith, Ph.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beverage Choice and Lifestyle Modification and Nutrition Education (NE) in people with Obesity, run by University of Pennsylvania at 1 site in United States.
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 3 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 15 Aug 2012. 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 United States. 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 (BMI) (time frame: Baseline and Month 6). The study lists 8 primary outcomes in all. 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 15 Aug 2012.