N/A
N=154
In-home Obesity Prevention to Reach Low-income Infants
Obesity · Obesity, Childhood · Obesity; Familial
Bottom Line
View on ClinicalTrials.gov: NCT03529695 ↗Enrolled (actual)
154
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Mother BMI — 30.6; 34.2; 34; 34.3 kg/m^2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard HVP Curriculum (Behavioral); Obesity Prevention (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- Female
- Sponsor
- University of Southern California
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mother BMI |
30.6; 34.2; 34; 34.3; 32; 35.4 | — |
| PRIMARY Infant Weight |
20.0; 19.3; 24.2; 22.1; 30.3; 28.9 | — |
| SECONDARY Fruit Intake Frequency |
7; 3; 13; 21; 11; 17 | — |
| SECONDARY Vegetable Intake Frequency |
7; 4; 13; 21; 16; 15 | — |
| SECONDARY Fried Food Intake Frequency |
16; 19; 27; 36; 12; 17 | — |
| SECONDARY Soda Intake Frequency |
20; 21; 31; 42; 9; 16 | — |
| SECONDARY Fruit Juice Intake Frequency |
18; 12; 24; 32; 10; 22 | — |
| SECONDARY Mother Movement Frequency |
8; 8; 13; 12; 10; 17 | — |
| SECONDARY Frequency of Infant Supervised Active Movement (Activity) |
1; 5; 6; 11; 5; 9 | — |
Summary
Existing obesity prevention efforts have had limited success among underserved, low-income children. This study capitalizes on the strengths of a nationwide ongoing Home Visitation Program (HVP), which serves at-risk, low-income, ethnically/racially diverse mothers and their infants, to test the effectiveness of delivering obesity prevention as part of their weekly, in-home services. The study will evaluate whether the integration of an obesity prevention enhancement module into existing HVP services, reduces the risk and incidence of obesity and associated risk factors in mothers and infants, compared to the provision of standard home visitation services. The study also focuses on the role of maternal factors (maternal diet, physical activity, food insecurity and feeding practices) and social factors (social network support) as mechanisms operating on infant outcomes.
Eligibility Criteria
*Important: Mother (or caregiver) and child dyads are enrolled together. Both must meet inclusion criteria to participate.
Inclusion Criteria
Mothers:
- Enrolled in a partnered home visitation program
- Mother or primary caregiver of 2-8 month old child
- BMI above 18.5
- Generally Healthy
Children:
- 2-8 months of age at time of enrollment
- Parent or primary caregiver receiving home visitation services
Exclusion Criteria
Mothers:
- Any history of an eating or feeding disorder, or obesity related syndrome (such as Prader-Willi)
- Diagnosis of Schizophrenia
- Currently enrolled in a diet and weight loss program, AND either a) significant weight loss of 10+ pounds in the last 6 months, OR b) unwilling to discontinue from current diet and weight loss program.
Infants:
- Infant is clinically underweight (<5th percentile) or has a history of a feeding or eating disorder
Data sourced from ClinicalTrials.gov (NCT03529695). 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.