N/A
N=277
Toddler Overweight Prevention Study Among Low-Income Families
Overweight · Obesity · Depression
Bottom Line
View on ClinicalTrials.gov: NCT02615158 ↗Enrolled (actual)
277
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Change of Body Mass Index (BMI) Z-score for Toddlers — 0.49; 0.50; 0.62; 0.52 z-score — p=0.555
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Maternal Physical Activity and Nutrition (Behavioral); Parenting (Behavioral); Child Safety (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Body Mass Index (BMI) Z-score for Toddlers |
0.49; 0.50; 0.62; 0.52; 0.61; 0.57 | 0.555 |
| PRIMARY Change in Body Mass Index (BMI) Score Among Mothers |
31.98; 31.90; 31.51; 32.22; 32.21; 31.85 | 0.739 |
| SECONDARY Change of Diet Quality for Toddlers |
52.44; 54.58; 55.1; 52.84; 52.49; 52.19 | 0.168 |
| SECONDARY Change of Diet Quality for Mothers |
46.88; 48.71; 48.52; 48.39; 46.90; 46.74 | 0.186 |
| SECONDARY Change of Child Physical Activity |
44.56; 52.39; 64.18; 73.10; 71.05; 69.05 | 0.034 sig |
| SECONDARY Change of Maternal Physical Activity |
23.10; 26.11; 27.76; 27.41; 20.42; 21.09 | 0.024 sig |
| SECONDARY Feeding Style |
4.69; 4.42; 4.71; 5.07; 5.19; 5.46 | 0.056 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02615158). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.