Toddler Overweight Prevention: Comparison of Maternal and Toddler Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 277
- Locations
- 2
- Primary Endpoint
- Change in Body Mass Index (BMI) Score Among Mothers
Study Overview
Brief Summary
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.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •At least 18 yrs old
- •Has child between 12-32 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
Arms & Interventions
Maternal Physical Activity and Nutrition
A maternal intervention focusing on healthy diet and physical activity patterns for mothers.
Intervention: Maternal Physical Activity and Nutrition (Behavioral)
Parenting
A toddler parenting intervention focusing on parenting, limit setting, and development strategies.
Intervention: Parenting (Behavioral)
Child Safety
Attention control group. The parents received intervention to promote safety among toddlers.
Intervention: Child Safety (Behavioral)
Outcomes
Primary Outcomes
Change in Body Mass Index (BMI) Score Among Mothers
Time Frame: Baseline to 12 month Follow-up
Change body mass index (BMI, kg/m\^2, calculated by measured weight and height) from baseline to 12-month follow-up. The BMI ranges usually ranges from 0-50 with higher score indicating higher weight regarding the height. Scores above 25 are considered overweight and scores above 30 are considered obese.
Change of Body Mass Index (BMI) Z-score for Toddlers
Time Frame: Baseline to 12-month Follow-up
Measured weight and height for the toddlers, transferred to age and gender-specific body mass index (BMI) Z-score. The range of BMI z-score is usually between -5 and +5. BMI z-score lower than -1.645 is defined as underweight. The BMI z-score from -1.645 to 1.036 is normal weight and BMI z-score greater or equal to 1.645 is obese.
Secondary Outcomes
- Change of Maternal Physical Activity(Baseline-12 month follow up)
- Change of Diet Quality for Toddlers(Baseline to 12-month Follow-up)
- Change of Diet Quality for Mothers(Baseline to 12-month Follow-up)
- Change of Child Physical Activity(Baseline to 12-month Follow-up)
- Feeding Style(Baseline to 12 month Follow-up)
Investigators
Maureen Black
Professor
University of Maryland, Baltimore