Cardiovascular DiseasesNCT00241891
Behavior Change Family Counseling to Reduce Rate of Weight Gain in At-Risk Children
A study testing Single behavior intervention and Multiple behavior interventions in people with Cardiovascular Diseases and Heart Diseases, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This study will train primary care providers to counsel families on behavior change that is aimed at reducing the rate of weight gain in at-risk children. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Obesity
- What is being tested?
- Single behavior intervention and Multiple behavior interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Feb 2015
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Sought care at the participating practices at least once in the 3 years prior to study entry
- Children "at risk for overweight" at their last clinical visit (according to the Center for Disease Control and Prevention [CDC] definition of a BMI at or above the 50th percentile, but less than the 95th percentile)
- Children who consume at least 28 oz of sweetened beverages per week (i.e., an average of 4 oz per day) as assessed during the telephone screening by selected components of a validated food frequency questionnaire
- The following conditions will be acceptable if they have been well controlled in the 3 months prior to study entry: hypertension, dyslipidemia, sleep apnea, asthma, and insulin resistance without diabetes
Who cannot join
- Developmental delay requiring special education
- Depression
- Psychosis
- Eating disorder
- Significant orthopedic problems interfering with physical activity
- Diabetes
Show all 11Show fewer
- Any significant chronic condition potentially interfering with nutrition or physical activity
- Treated with a drug known to affect weight gain
- Measured BMI z-score at first visit higher than +2.0 Standard Deviations (97.7th percentile)
- Families who are uninterested or unable to participate
- Home-schooled
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Primary Care Obesity Prevention: One or Multiple Targets
This study will train primary care providers to counsel families on behavior change that is aimed at reducing the rate of weight gain in at-risk children.
Read the detailed description
BACKGROUND:
In addition to family, school, and community, primary care is a promising setting for childhood obesity prevention. However, most pediatric primary care providers are not trained to deliver behavior modification interventions and, according to preliminary data, are less likely to address obesity prevention when they perceive insufficient time during well-care visits.
DESIGN NARRATIVE:
This is a controlled study of obesity prevention, with group randomization of two standardized 12-month intervention strategies at the practice level. The intervention strategies are based on the behavioral economics theory and will be delivered by primary care providers after training in behavior modification. The first strategy will target change in multiple behaviors, while the second strategy will target only one behavior (beverage consumption). These two interventions will be compared to an active control intervention that is unrelated to weight (bullying prevention). Six to seven primary care practices will be randomized to each arm with 21 patients per practice, for a total of 17 practices and 350 patients. The primary aim is to demonstrate that either obesity prevention intervention will result in less body mass index (BMI) increase (adjusted using z-score) in children age 8 to 12 years who are at risk for overweight (BMI 50th-95th percentile), as compared to a control intervention. The study also hypothesizes that the multiple-behavior intervention, the single-behavior intervention, or both will result in less adjusted BMI increase than the control intervention at 24 months post-randomization, with no a priori assumption in differences between the two obesity prevention strategies. Blood pressure, insulin resistance, dyslipidemia, and oral health status will be secondary outcomes. Intermediate behavioral outcomes and process data will be collected.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Being tested
- Single behavior intervention, Multiple behavior interventions, Control Intervention unrelated to weight
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single behavior interventionBehavioural
Also called Focused on changing beverage choices with the goal
Focused on changing beverage choices which may have a significant impact on weight.
Multiple behavior interventionsBehavioural
Focused on multiple behaviors (nutrition, beverages, physical activity, and sedentary lifestyle) which may have a significant impact on weight.
Control Intervention unrelated to weightBehavioural
Focused on standard intervention strategies unrelated to weight including bullying prevention.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Lifestyle (Active Intervention) | Other | Parents and children in this program which will participate in a series of consultations and activities focused on multiple healthy interventions including healthy eating, drinking, and physical activity. The children will participate in a variety of age-appropriate games, activities and exercises that are focused on healthy eating, drinking, and physical activity. In addition, your child will receive information on developing healthy interpersonal and social skills. Receives: Behavioral: Multiple behavior interventions |
| Healthy Drinks (Active Intervention) | Other | Parents and children in this program will participate in a series of consultations and activities focused on a single intervention, the effects of beverage choices on diet, general health and teeth health. The children will participate in a variety of age-appropriate games, activities and exercises that are focused on beverages and health. In addition, your child will receive information on healthy nutrition, physical activity, and interpersonal and social skills. Receives: Behavioral: Single behavior intervention |
| Social and Leadership Skills (Control Intervention) | Other | Parents and children in this program will participate in a series of consultations that are designed to help your child learn strategies to make and keep friends, to express feelings appropriately, and to successfully decrease conflicts that often occur at school among children. The children will participate in a variety of age-appropriate games, activities and exercises that are focused on these friendship making strategies. In addition, your child will receive information on healthy nutrition and physical activity. There is o intervention with regards to healthy weight. Receives: Behavioral: Control Intervention unrelated to weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in BMI z-score
Measured: Measured at Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
- Study startJul 2006
- Primary completionMay 2011
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Stephen Leff, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241891
- Sponsor's protocol ID
- 2005-7-4442
- Other IDs
- R01HL084056
- Status last verified
- Apr 2015
- First submitted
- 17 Oct 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Stettler N, Wrotniak BH, Hill DL, Kumanyika SK, Xanthopoulos MS, Nihtianova S, Shults J, Leff SS, Pinto A, Berkowitz RI, Faith MS. Prevention of excess weight gain in paediatric primary care: beverages only or multiple lifestyle factors. The Smart Step Study, a cluster-randomized clinical trial. Pediatr Obes. 2015 Aug;10(4):267-74. doi: 10.1111/ijpo.260. Epub 2014 Sep 24.
PubMed 25251166
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Obesity Prevention: One or Multiple Targets
- ClinicalTrials.gov ID
- NCT00241891
- Acronym / sponsor ID
- 2005-7-4442
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2006
- Primary completion
- May 2011 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 19 Oct 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.
This study will train primary care providers to counsel families on behavior change that is aimed at reducing the rate of weight gain in at-risk children.
Detailed description
BACKGROUND:
In addition to family, school, and community, primary care is a promising setting for childhood obesity prevention. However, most pediatric primary care providers are not trained to deliver behavior modification interventions and, according to preliminary data, are less likely to address obesity prevention when they perceive insufficient time during well-care visits.
DESIGN NARRATIVE:
This is a controlled study of obesity prevention, with group randomization of two standardized 12-month intervention strategies at the practice level. The intervention strategies are based on the behavioral economics theory and will be delivered by primary care providers after training in behavior modification. The first strategy will target change in multiple behaviors, while the second strategy will target only one behavior (beverage consumption). These two interventions will be compared to an active control intervention that is unrelated to weight (bullying prevention). Six to seven primary care practices will be randomized to each arm with 21 patients per practice, for a total of 17 practices and 350 patients. The primary aim is to demonstrate that either obesity prevention intervention will result in less body mass index (BMI) increase (adjusted using z-score) in children age 8 to 12 years who are at risk for overweight (BMI 50th-95th percentile), as compared to a control intervention. The study also hypothesizes that the multiple-behavior intervention, the single-behavior intervention, or both will result in less adjusted BMI increase than the control intervention at 24 months post-randomization, with no a priori assumption in differences between the two obesity prevention strategies. Blood pressure, insulin resistance, dyslipidemia, and oral health status will be secondary outcomes. Intermediate behavioral outcomes and process data will be collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Lifestyle (Active Intervention) | Other | Behavioral: Multiple behavior interventionsParents and children in this program which will participate in a series of consultations and activities focused on multiple healthy interventions including healthy eating, drinking, and physical activity. The children will participate in a variety of age-appropriate games, activities and exercises that are focused on healthy eating, drinking, and physical activity. In addition, your child will receive information on developing healthy interpersonal and social skills. |
| Healthy Drinks (Active Intervention) | Other | Behavioral: Single behavior interventionParents and children in this program will participate in a series of consultations and activities focused on a single intervention, the effects of beverage choices on diet, general health and teeth health. The children will participate in a variety of age-appropriate games, activities and exercises that are focused on beverages and health. In addition, your child will receive information on healthy nutrition, physical activity, and interpersonal and social skills. |
| Social and Leadership Skills (Control Intervention) | Other | Behavioral: Control Intervention unrelated to weightParents and children in this program will participate in a series of consultations that are designed to help your child learn strategies to make and keep friends, to express feelings appropriately, and to successfully decrease conflicts that often occur at school among children. The children will participate in a variety of age-appropriate games, activities and exercises that are focused on these friendship making strategies. In addition, your child will receive information on healthy nutrition and physical activity. There is o intervention with regards to healthy weight. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Sought care at the participating practices at least once in the 3 years prior to study entry
- Children "at risk for overweight" at their last clinical visit (according to the Center for Disease Control and Prevention [CDC] definition of a BMI at or above the 50th percentile, but less than the 95th percentile)
- Children who consume at least 28 oz of sweetened beverages per week (i.e., an average of 4 oz per day) as assessed during the telephone screening by selected components of a validated food frequency questionnaire
- The following conditions will be acceptable if they have been well controlled in the 3 months prior to study entry: hypertension, dyslipidemia, sleep apnea, asthma, and insulin resistance without diabetes
Key exclusion criteria (11 listed)
- Developmental delay requiring special education
- Depression
- Psychosis
- Eating disorder
- Significant orthopedic problems interfering with physical activity
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 |
|---|---|---|
| Single behavior interventionAlso: Focused on changing beverage choices with the goalFocused on changing beverage choices which may have a significant impact on weight. | Behavioural | Healthy Drinks (Active Intervention) |
| Multiple behavior interventionsFocused on multiple behaviors (nutrition, beverages, physical activity, and sedentary lifestyle) which may have a significant impact on weight. | Behavioural | Healthy Lifestyle (Active Intervention) |
| Control Intervention unrelated to weightFocused on standard intervention strategies unrelated to weight including bullying prevention. | Behavioural | Social and Leadership Skills (Control Intervention) |
Primary outcome
Changes in BMI z-score
Time frame: Measured at Month 12
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 7 Apr 2015.
- Derived from this study: PubMed 25251166Stettler N, Wrotniak BH, Hill DL, Kumanyika SK, Xanthopoulos MS, Nihtianova S, Shults J, Leff SS, Pinto A, Berkowitz RI, Faith MS. Prevention of excess weight gain in paediatric primary care: beverages only or multiple lifestyle factors. The Smart Step Study, a cluster-randomized clinical trial. Pediatr Obes. 2015 Aug;10(4):267-74. doi: 10.1111/ijpo.260. Epub 2014 Sep 24.
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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.
Stephen Leff, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single behavior intervention and Multiple behavior interventions in people with Cardiovascular Diseases and Heart Diseases, run by Children's Hospital of Philadelphia 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 4 inclusion and 11 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 7 Apr 2015. 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?
Changes in BMI z-score (time frame: Measured at Month 12). 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 NCT00241891, which also lists 1 linked publication.
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 7 Apr 2015.