Behavior Change Family Counseling to Reduce Rate of Weight Gain in At-Risk Children
Primary Care Obesity Prevention: One or Multiple Targets
2 other identifiers
interventional
158
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cardiovascular-diseases
Started Jul 2006
Longer than P75 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2005
CompletedFirst Posted
Study publicly available on registry
October 19, 2005
CompletedStudy Start
First participant enrolled
July 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedApril 7, 2015
April 1, 2015
4.8 years
October 17, 2005
April 6, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in BMI z-score
Measured at Month 12
Study Arms (3)
Healthy Lifestyle (Active Intervention)
OTHERParents 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)
OTHERParents 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)
OTHERParents 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.
Interventions
Focused on changing beverage choices which may have a significant impact on weight.
Focused on multiple behaviors (nutrition, beverages, physical activity, and sedentary lifestyle) which may have a significant impact on weight.
Focused on standard intervention strategies unrelated to weight including bullying prevention.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Developmental delay requiring special education
- Depression
- Psychosis
- Eating disorder
- Significant orthopedic problems interfering with physical activity
- Diabetes
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
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.
PMID: 25251166DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Leff, PhD
Children's Hospital of Philadelphia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2005
First Posted
October 19, 2005
Study Start
July 1, 2006
Primary Completion
May 1, 2011
Study Completion
February 1, 2015
Last Updated
April 7, 2015
Record last verified: 2015-04