ObesityNCT01662557
Treatment of Early Childhood Overweight in Primary Care: Pilot Study
A study testing Family Behavior Modification and Minimal Nutrition Information in people with Obesity, run by University of Pennsylvania at 1 site in United States.
Trial summary
Childhood overweight continues to increase at an alarming rate and the need exists to find effective, accessible intervention strategies to prevent and treat children who are at risk for being overweight or are already overweight. 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?
- Family Behavior Modification and Minimal Nutrition Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Mar 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
- 4-8 year old children
- overweight or obese (BMI≥85th percentile, based on age and sex)
- Parent/primary caregiver willing to attend sessions with child
Who cannot join
- Failure to meet BMI criteria
- Child with elevated internalizing or externalizing behavioral problems, as assessed through Child Behavior Checklist (CBCL)
- Elevated parent distress, as measured by Symptom Checklist-90 (SCL-90)
- Child on medications with any weight-altering effect
- Inability to participate in moderate physical activity or attend study visits
- Residing >1 hour from study site
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
Childhood overweight continues to increase at an alarming rate and the need exists to find effective, accessible intervention strategies to prevent and treat children who are at risk for being overweight or are already overweight. The primary care setting provides an attractive option for families wishing to receive treatment, yet little is known about the feasibility, acceptance or efficacy of this intervention setting. The purpose of this study was to test two different primary care treatments that were intended to increase fruit and vegetable intake, increase physical activity, and reduce sedentary activity in children ages 4-8, who are overweight or at risk for becoming overweight. Both treatments involved the child and a parent/caregiver and both were conducted over a four month period. The parent/child dyads were selected from the pool of families who receive their primary care within the Geisinger Medical Center geographic area and who have been identified by their pediatrician as being overweight or at risk for becoming overweight (BMI >85th percentile for age). One group received weekly mailings which focused on healthy eating, promotion of fruit and vegetable intake and physical activity, and methods to reduce TV viewing time. The second group received a group-based intervention at one of the Geisinger Pediatric Clinic sites using specific behavioral strategies for increasing fruit and vegetable intake, reducing TV viewing and encouraging physical activity. Changes in overweight percentage, child BMI, lipid profile, glucose/insulin levels, and anthropometric measurements were analyzed, as well as treatment satisfaction and acceptance. The investigators hypothesized that children who receive Family Behavior Modification (FBM) in the primary care setting will show greater reductions in Body Mass Index (BMI), BMI z-score, percent overweight and waist circumference, and that children receiving FBM will show greater improvements in dietary intake, increased physical activity, reduced sedentary activity, and improvements in cardiovascular outcomes.
- Conditions
- Obesity
- Being tested
- Family Behavior Modification, Minimal Nutrition Information
- Keywords
- Pediatric Obesity
- 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.
Family Behavior ModificationBehavioural
Also called FBM
5-month intervention for parents and children providing 15 sessions in behavioral skills training in self monitoring, Traffic Light Diet, goal setting, reinforcement and tasting sessions. Of the 15 sessions, 3 were structured as phone sessions.
Minimal Nutrition InformationOther
Also called MNI
Families assigned to MNI received a series of 15 mailings on topics related identifying a healthy body weight for children; energy balance and calorie requirements for children; MyPyramid for Kids; portion control; the benefits of physical activity and screen-time reduction; encouraging fruit and vegetable consumption; healthy snacks and smart shopping; and encouraging family meals.
| Study group | Role | What they receive |
|---|---|---|
| Family Behavior Modification | Active comparator | Family-based behavior modification with parent and child using goal setting, self monitoring, reinforcement, behavioral skills training, and tasting opportunities. Receives: Behavioral: Family Behavior Modification |
| Minimal Nutrition Information | Other | Weekly mailings emphasizing healthy eating guidelines for families. Receives: Other: Minimal Nutrition Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child's Overweight Percentage
Change in child's overweight percentage will be measured from baseline to end of treatment (month 5)
Measured: Baseline and Month 5
Body Mass Index z-score (BMI-z)
Change in BMI-z score will be measured from baseline to end of treatment (month 5)
Measured: Baseline and Month 5
Waist Circumference
Change in child's waist circumference will be measured from baseline to end of treatment (month 5).
Measured: Baseline and Month 5
Body Mass Index (BMI)
Change in BMI will be measured from baseline to end of treatment (month 5).
Measured: Baseline and Month 5
Secondary outcomes (7)
Dietary Intake
Change in dietary intake (kcals, protein, fat, saturated fat, cholesterol, fiber, carbohydrate, fruit/veg servings, Vitamins A and C) will be assessed from baseline to end of treatment (month 5) using 24-hour recall interviews.
Measured: Baseline and Month 5
Activity Level
Physical activity (sedentary, light, moderate and moderate to vigorous) will be assessed via accelerometry between baseline and end of treatment (month 5).
Measured: Baseline to Month 5
Insulin (uUnits/ml)
Change in fasting insulin will be measured at baseline and end of treatment (month 5).
Measured: Baseline and Month 5
Glucose (mg/dl)
Change in fasting glucose levels will be measured from baseline to end of treatment (month 5).
Measured: Baseline and Month 5
Triglycerides (mg/dl)
Change in fasting triglyceride levels will be measured from baseline to end of treatment (month 5).
Measured: Baseline and Month 5
HDL (mg/dl)
Change in HDL levels will be measured from baseline to end of treatment (month 5).
Measured: Baseline and Month 5
LDL (mg/dl)
Change in LDL levels will be measured from baseline to end of treatment (month 5).
Measured: Baseline and Month 5
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 startFeb 2008
- Primary completionMar 2011
- Study completionMar 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Geisinger Center for Health Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Myles S Faith, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662557
- Sponsor's protocol ID
- 807610
- Other IDs
- R34DK080473
- Status last verified
- Jan 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
- Treatment of Early Childhood Overweight in Primary Care: Pilot Study
- ClinicalTrials.gov ID
- NCT01662557
- Acronym / sponsor ID
- 807610
- Conditions
- Obesity
- Keywords
- Pediatric Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Geisinger Center for Health Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Feb 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 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.
Childhood overweight continues to increase at an alarming rate and the need exists to find effective, accessible intervention strategies to prevent and treat children who are at risk for being overweight or are already overweight. The primary care setting provides an attractive option for families wishing to receive treatment, yet little is known about the feasibility, acceptance or efficacy of this intervention setting. The purpose of this study was to test two different primary care treatments that were intended to increase fruit and vegetable intake, increase physical activity, and reduce sedentary activity in children ages 4-8, who are overweight or at risk for becoming overweight. Both treatments involved the child and a parent/caregiver and both were conducted over a four month period. The parent/child dyads were selected from the pool of families who receive their primary care within the Geisinger Medical Center geographic area and who have been identified by their pediatrician as being overweight or at risk for becoming overweight (BMI >85th percentile for age). One group received weekly mailings which focused on healthy eating, promotion of fruit and vegetable intake and physical activity, and methods to reduce TV viewing time. The second group received a group-based intervention at one of the Geisinger Pediatric Clinic sites using specific behavioral strategies for increasing fruit and vegetable intake, reducing TV viewing and encouraging physical activity. Changes in overweight percentage, child BMI, lipid profile, glucose/insulin levels, and anthropometric measurements were analyzed, as well as treatment satisfaction and acceptance. The investigators hypothesized that children who receive Family Behavior Modification (FBM) in the primary care setting will show greater reductions in Body Mass Index (BMI), BMI z-score, percent overweight and waist circumference, and that children receiving FBM will show greater improvements in dietary intake, increased physical activity, reduced sedentary activity, and improvements in cardiovascular outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Behavior Modification | Active comparator | Behavioral: Family Behavior ModificationFamily-based behavior modification with parent and child using goal setting, self monitoring, reinforcement, behavioral skills training, and tasting opportunities. |
| Minimal Nutrition Information | Other | Other: Minimal Nutrition InformationWeekly mailings emphasizing healthy eating guidelines for families. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 4-8 year old children
- overweight or obese (BMI≥85th percentile, based on age and sex)
- Parent/primary caregiver willing to attend sessions with child
Key exclusion criteria (6 listed)
- Failure to meet BMI criteria
- Child with elevated internalizing or externalizing behavioral problems, as assessed through Child Behavior Checklist (CBCL)
- Elevated parent distress, as measured by Symptom Checklist-90 (SCL-90)
- Child on medications with any weight-altering effect
- Inability to participate in moderate physical activity or attend study visits
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 |
|---|---|---|
| Family Behavior ModificationAlso: FBM5-month intervention for parents and children providing 15 sessions in behavioral skills training in self monitoring, Traffic Light Diet, goal setting, reinforcement and tasting sessions. Of the 15 sessions, 3 were structured as phone sessions. | Behavioural | Family Behavior Modification |
| Minimal Nutrition InformationAlso: MNIFamilies assigned to MNI received a series of 15 mailings on topics related identifying a healthy body weight for children; energy balance and calorie requirements for children; MyPyramid for Kids; portion control; the benefits of physical activity and screen-time reduction; encouraging fruit and vegetable consumption; healthy snacks and smart shopping; and encouraging family meals. | Other | Minimal Nutrition Information |
Primary outcome
Child's Overweight Percentage
Time frame: Baseline and Month 5
Change in child's overweight percentage will be measured from baseline to end of treatment (month 5)
Body Mass Index z-score (BMI-z)
Time frame: Baseline and Month 5
Change in BMI-z score will be measured from baseline to end of treatment (month 5)
Waist Circumference
Time frame: Baseline and Month 5
Change in child's waist circumference will be measured from baseline to end of treatment (month 5).
Body Mass Index (BMI)
Time frame: Baseline and Month 5
Change in BMI will be measured from baseline to end of treatment (month 5).
7 secondary outcomes
Dietary Intake
Time frame: Baseline and Month 5
Activity Level
Time frame: Baseline to Month 5
Insulin (uUnits/ml)
Time frame: Baseline and Month 5
Glucose (mg/dl)
Time frame: Baseline and Month 5
Triglycerides (mg/dl)
Time frame: Baseline and Month 5
HDL (mg/dl)
Time frame: Baseline and Month 5
LDL (mg/dl)
Time frame: Baseline and Month 5
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 Family Behavior Modification and Minimal Nutrition Information 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 6 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?
Child's Overweight Percentage (time frame: Baseline and Month 5). The study lists 4 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.