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Trial record 1 of 1 for:    NCT02615158
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Toddler Overweight Prevention Study Among Low-Income Families (TOPS)

This study has been completed.
Sponsor:
Collaborators:
Johns Hopkins University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Maureen Black, University of Maryland
ClinicalTrials.gov Identifier:
NCT02615158
First received: February 11, 2013
Last updated: November 23, 2015
Last verified: November 2015
  Purpose
The hypothesis is that toddlers with parents who are randomized to a parenting intervention and toddlers with parents who are randomized to the maternal intervention focused on maternal diet and physical activity will be more likely to have weight status within normal and to consume a healthy diet and engage in physical activity than toddlers with parents in a placebo (safety) intervention.

Condition Intervention
Overweight Obesity Depression Behavioral: Maternal Physical Activity and Nutrition Behavioral: Parenting Behavioral: Child Safety

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Toddler Overweight Prevention: Comparison of Maternal and Toddler Intervention

Resource links provided by NLM:


Further study details as provided by Maureen Black, University of Maryland:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 277
Study Start Date: April 2006
Study Completion Date: May 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Experimental: Parenting
A toddler parenting intervention focusing on parenting, limit setting, and development strategies.
Behavioral: Parenting
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.

Detailed Description:

Background:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 yrs old
  • Has child between 12-30 months
  • Child able to walk
  • Birth weight of child at least 5lbs. 8oz.

Exclusion Criteria:

  • Mom cannot be pregnant
  • No known congenital problems or disabilities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02615158

Locations
United States, Maryland
University of Maryland, School of Medicine
Baltimore, Maryland, United States, 21201
University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Johns Hopkins University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Maureen M Black, PhD University of Maryland
  More Information

Publications:
Responsible Party: Maureen Black, Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT02615158     History of Changes
Other Study ID Numbers: H-27980
R01HD056099 ( U.S. NIH Grant/Contract )
R03HD077156 ( U.S. NIH Grant/Contract )
Study First Received: February 11, 2013
Last Updated: November 23, 2015

Keywords provided by Maureen Black, University of Maryland:
Feeding practices
Diet
Physical activity
Prevention

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 23, 2017