Obesity Clinical Trial
Official title:
In-home Obesity Prevention to Reach Low-income Infants Through Maternal and Social Transmission
Verified date | September 2023 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 156 |
Est. completion date | May 31, 2023 |
Est. primary completion date | January 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 2 Months and older |
Eligibility | *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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Southern California | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | Antelope Valley Partners for Health, Cedars-Sinai Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Demographic History | Self-reported demographic history (gender, age, race, household income, etc) will be collected. Acculturation is measured using the Demographic Index of Cultural Exposure (DICE). | Baseline | |
Other | Medical History | Self-reported medical history (prescription medications, child and parent/caregiver illnesses, etc.) will be collected | Baseline, 6 months, 12 months | |
Other | Depression | The Edinburgh Postnatal Depression Scale (EPDS) will be used to determine maternal depression. Each of the 10 items has 4 optional responses with a set coding frame. Scores are summed and can range from 0 to 30. Values over 11 are indicative of risk for postnatal depression. | Baseline, 6 months, 12 months | |
Other | Mother's Blood Pressure | Blood pressure will be collected prior to all blood draws | Baseline, 12 months | |
Other | Mother height and infant length | Mother height and infant length in inches will be measured by trained assessment workers. This will be combined with measures of mother and infant weight to compute body mass index (BMI) for mothers (kg/m^2); and infant weight-for-length based on World Health Organization (WHO) standards. | Baseline, 6 months, 12 months | |
Primary | BMI of mothers | BMI at each assessment. | Baseline, 6 months, 12 months | |
Primary | Weight of infants | weight in pounds at each assessments | Baseline, 6 months, 12 months | |
Secondary | Maternal eating, feeding, and activity behaviors | Assessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES), amended to measure target eating and feeding habits of the mother. | Baseline, 6 months, 12 months | |
Secondary | Infant eating and activity behaviors | Assessed using modified food and activity frequency measure from NHANES, as reported by the mother, and amended to measure target eating and activity. | Baseline, 6 months, 12 months | |
Secondary | Habit strength of maternal eating, activity, and feeding behaviors | Habit strength will be assessed using the Self-Reported Habit Index (SRHI) specific to target eating and activity behaviors. | Baseline, 6 months, 12 months | |
Secondary | Household food environment | Household environment assessing availability, accessibility, and visibility of food items will be assessed using a modified Home Food Assessment (HFA) and Home - Inventory Describing Eating and Activity Development (H-IDEA), relating to the target eating behaviors. | Baseline, 6 months, 12 months | |
Secondary | Household activity environment | Household environment assessing availability, accessibility, and visibility of activity items will be assessed using a modified Home Food Assessment (HFA) and Home - Inventory Describing Eating and Activity Development (H-IDEA), relating to the target activity behaviors. | Baseline, 6 months, 12 months | |
Secondary | Social network support | The characteristics of the social actors (people, organizations) and relationships that surround mothers will be assessed using egocentric social network methods and social network analysis (SNA) to compute the density of relationships that provide health-related social support. | Baseline, 6 months, 12 months | |
Secondary | Social network health norms | The characteristics of the social actors (people) and relationships that surround mothers will be assessed using egocentric social network methods and social network analysis (SNA) to compute the health behavior and weight norms. | Baseline, 6 months, 12 months | |
Secondary | Maternal emotional support | Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form scale for emotional support. | Baseline, 6 months, 12 months | |
Secondary | Maternal instrumental support | Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form scale for instrumental support. | Baseline, 6 months, 12 months | |
Secondary | Maternal social isolation | Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form scale for social isolation. | Baseline, 6 months, 12 months | |
Secondary | Maternal Food Security | The U.S. Adult Food Security Survey Module will be used to evaluate hunger and food sufficiency to meet the basic needs of families. | Baseline, 6 months, 12 months |
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