Toddler Overweight Prevention Study Among Low-Income Families (TOPS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02615158|
Recruitment Status : Completed
First Posted : November 26, 2015
Last Update Posted : November 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity Depression||Behavioral: Maternal Physical Activity and Nutrition Behavioral: Parenting Behavioral: Child Safety||Not Applicable|
Overweight is a serious public health problem which can begin in early childhood. Factors which contribute to overweight include: overfeeding, excessive intakes of fat and sugar; frequent sedentary activities (i.e. television watching).
Overweight, defined as a BMI > 95th percentile, in early childhood has reached epidemic proportions with 14% of 2-5 year olds overweight and 26.2% "at risk of overweight," defined as a BMI > 85th percentile (Ogden et al., 2006).
Dietary and physical activity patterns established early in life track over time, making the first few years of life an ideal time to help families establish healthy eating and physical activity behaviors and avoid overweight. This project works to identify techniques that could prevent overweight.
Purpose of Study:
The investigators are collaborating with the Anne Arundel County, MD WIC Program and the University of Maryland's Pediatric Ambulatory Center to implement strategies that will prevent overweight among toddlers. The project focuses on the dietary, physical activity, and growth patterns of WIC toddlers. The investigators are conducting a 3-cell randomized trial consisting of: 1) a maternal intervention focusing on healthy diet and physical activity patterns for mothers; 2) a toddler parenting intervention focusing on parenting, limit setting, and development strategies; and 3) an intervention on child safety. The interventions are implemented over 3 months, with 8 sessions.
The investigators hypothesize that altering maternal behavior will have a positive impact on the growth and development of the toddler by preventing behaviors that lead to overweight among children. The parenting intervention will improve parenting skills by offering information on proper approaches to feeding, discipline and educational play. The investigators will compare the growth patterns of toddlers whose mothers were randomized to the maternal and parenting interventions with those in the safety intervention. This study design allows us to examine the mechanisms linking the interventions to improvements in diet, physical activity, and growth.
In addition, the investigators will conduct the safety promotion intervention for the attention control group, considering the high risk of unintentional injuries among the toddlers from low-income families. The investigators also hypothesize that the safety promotion intervention will reduce the safety problems of the toddlers' homes. The underlying mechanisms will be examined, if there is a significant intervention effect.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||277 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Toddler Overweight Prevention: Comparison of Maternal and Toddler Intervention|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||May 2014|
Experimental: Maternal Physical Activity and Nutrition
A maternal intervention focusing on healthy diet and physical activity patterns for mothers.
Behavioral: Maternal Physical Activity and Nutrition
At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.
A toddler parenting intervention focusing on parenting, limit setting, and development strategies.
Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.
Experimental: Child Safety
Attention control group. The parents received intervention to promote safety among toddlers.
Behavioral: Child Safety
The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.
- Change of Body Mass Index (BMI) for mothers or BMI Zscore for toddlers [ Time Frame: baseline to 6 or 12-month ]Measured weight and height for the toddlers, transferred to age and gender-specific BMI Zscore; Mother Body Mass Index based on measured height and weight
- Change of Diet Quality for mothers and toddlers [ Time Frame: Baseline to 6 or 12-month ]Healthy Eating Index (HEI) based on 24-hr diet recall
- Change of Physical Activity for mothers and toddlers [ Time Frame: Baseline to 6 or 12-month ]Moderate to Vigorous Physical Activity (MVPA) based on anthropometrics
- Change of home Safety Problems [ Time Frame: Baseline to 6 or 12-month ]9-item observational checklist of danger and safety features at homes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615158
|United States, Maryland|
|University of Maryland, School of Medicine|
|Baltimore, Maryland, United States, 21201|
|University of Maryland|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Maureen M Black, PhD||University of Maryland|