N/A
N=296
Healthy Homes, Healthy Habits
Obesity · Obesity, Childhood · Obesity; Familial
Bottom Line
View on ClinicalTrials.gov: NCT03433456 ↗Enrolled (actual)
296
Serious AEs
0.7%
Results posted
Apr 2024
Primary outcome: Primary: Weight of Mothers — 88.65; 97.43; 85.96; 96.52 Kilograms
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Home visitation + HABITS program (Behavioral); Standard home visitation program (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight of Mothers |
88.65; 97.43; 85.96; 96.52; 85.94; 98.75 | — |
| PRIMARY Weight of Children |
13.88; 14.23; 15.40; 15.94; 16.83; 17.58 | — |
| SECONDARY Habit Strength of Targeted Behaviors |
3.58; 3.67; 3.86; 3.95; 3.91; 4.26 | — |
| SECONDARY Household Environment Assessing the Number of Different Food Items Available |
5.01; 5.64; 6.00; 5.58; 5.28; 5.66 | — |
| SECONDARY Household Environment Assessing the Number of Different Activity-promoting Items Available |
3.96; 3.81; 4.59; 4.40; 4.30; 4.74 | — |
Summary
The purpose of this study is to evaluate whether an intervention targeting healthy habit development reduces the risk and prevalence of obesity in low-income mothers and children. The study intends to evaluate whether the intervention, delivered in the context of home visitation services for low-income families, reduces weight gain and risk factors associated with parent and childhood obesity compared to those receiving standard home visitation services.
Eligibility Criteria
Inclusion Criteria
*Important: Mother (or caregiver) and child dyads are enrolled together. Both must meet inclusion criteria to participate.
Mothers or Primary Caregivers:
- Age 18-75 years of age
- Enrollment in First Teacher Home Visiting Program (First Teacher) through the Family Guidance Center of Alabama.
- Mother or primary caregiver of 0-4 year old child
- Generally Healthy
Children:
- 0-4 years of age at time of enrollment
- Parent or primary caregiver enrolled in First Teacher
Exclusion Criteria
Mothers or primary caregivers:
- 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.
Children:
- Child has a history of a feeding or eating disorder
Data sourced from ClinicalTrials.gov (NCT03433456). 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.