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In-home Obesity Prevention to Reach Low-income Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529695
Recruitment Status : Enrolling by invitation
First Posted : May 18, 2018
Last Update Posted : September 11, 2020
Sponsor:
Collaborators:
Antelope Valley Partners for Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Kayla de la Haye, University of Southern California

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Obesity, Childhood Obesity; Familial Behavioral: Standard HVP Curriculum Behavioral: Obesity Prevention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment Randomization occurs at the level of home visitors who deliver the home visitation program curriculum. Home visitors will be randomized to deliver the home visitation program curriculum with (Experimental comparator) or without (Active Comparator) the obesity prevention enhancement module. Mother-child dyads enrolled in home visitation programs, and who agree to participate in the study, will receive the intervention arm delivered by their home visitor.
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: In-home Obesity Prevention to Reach Low-income Infants Through Maternal and Social Transmission
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : May 31, 2022

Arm Intervention/treatment
Active Comparator: Standard HVP Curriculum
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Behavioral: Standard HVP Curriculum
Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.

Experimental: Obesity Prevention
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Behavioral: Standard HVP Curriculum
Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.

Behavioral: Obesity Prevention
Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.




Primary Outcome Measures :
  1. Weight of mothers [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months ]
    change in body weight, in kilograms, from baseline to follow-up assessments.

  2. Rate of weight gain of infants [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months ]
    change in body weight, in kilograms, from baseline to follow-up assessments.

  3. Waist circumference of mothers [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months ]
    waist circumference, in centimeters, from baseline to follow-up assessments.


Secondary Outcome Measures :
  1. Mother blood glucose [ Time Frame: Baseline, 18 months ]
    Blood samples will be collected and assayed to test for blood glucose in mothers

  2. Mother blood lipids [ Time Frame: Baseline, 18 months ]
    Blood samples will be collected and assayed to test for lipid profiles in mothers

  3. Infant leptin [ Time Frame: Baseline, 18 months ]
    Blood samples will be collected and assayed to test for leptin in infants

  4. Infant adiponectin [ Time Frame: Baseline, 18 months ]
    Blood samples will be collected and assayed to test for adiponectin in infants

  5. Maternal eating, feeding, and activity behaviors [ Time Frame: Baseline, 6 months, 18 months ]
    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.

  6. Infant eating and activity behaviors [ Time Frame: Baseline, 6 months, 18 months ]
    Assessed using modified food and activity frequency measure from NHANES, as reported by the mother, and amended to measure target eating and activity.

  7. Habit strength of maternal eating, activity, and feeding behaviors [ Time Frame: Baseline, 6 months, 18 months ]
    Habit strength will be assessed using the Self-Reported Habit Index (SRHI) specific to target eating and activity behaviors.

  8. Household food environment [ Time Frame: Baseline, 6 months, 18 months ]
    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.

  9. Household activity environment [ Time Frame: Baseline, 6 months, 18 months ]
    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.

  10. Social network support [ Time Frame: Baseline, 6 months, 18 months ]
    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.

  11. Social network health norms [ Time Frame: Baseline, 6 months, 18 months ]
    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.

  12. Maternal emotional support [ Time Frame: Baseline, 6 months, 18 months ]
    Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form scale for emotional support.

  13. Maternal instrumental support [ Time Frame: Baseline, 6 months, 18 months ]
    Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form scale for instrumental support.

  14. Maternal social isolation [ Time Frame: Baseline, 6 months, 18 months ]
    Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form scale for social isolation.

  15. Maternal Food Security [ Time Frame: Baseline, 6 months, 18 months ]
    The U.S. Adult Food Security Survey Module will be used to evaluate hunger and food sufficiency to meet the basic needs of families.


Other Outcome Measures:
  1. Demographic History [ Time Frame: Baseline ]
    Self-reported demographic history (gender, age, race, household income, etc) will be collected. Acculturation is measured using the Demographic Index of Cultural Exposure (DICE).

  2. Medical History [ Time Frame: Baseline, 6 months, 18 months ]
    Self-reported medical history (prescription medications, child and parent/caregiver illnesses, etc.) will be collected

  3. Depression [ Time Frame: Baseline, 6 months, 18 months ]
    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.

  4. Mother's Blood Pressure [ Time Frame: Baseline, 18 months ]
    Blood pressure will be collected prior to all blood draws

  5. Mother height and infant length [ Time Frame: Baseline, 6 months, 18 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529695


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90089-9239
Sponsors and Collaborators
University of Southern California
Antelope Valley Partners for Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Kayla de la Haye, PhD University of Southern California
Principal Investigator: Sarah-Jeanne Salvy, PhD Cedars-Sinai Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kayla de la Haye, Assistant Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT03529695    
Other Study ID Numbers: 1R01HD092483-01 ( U.S. NIH Grant/Contract )
1R01HD092483-01 ( U.S. NIH Grant/Contract )
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Development, execution, and data collection for this study is completed with a Principle Investigator at the University of Alabama at Birmingham. Data will be shared with Dr. Salvy and her staff as appropriate. With documented permission of the IRB, a PI may develop a de-identified database, codebook, and mechanism by which data can be shared with qualified investigators. Interested Investigators will complete a request form stating the aims of their analyses, analytic plan, available resources for completing a project, timeline, and goals (i.e. manuscripts or grant applications). The PIs and their research team will review requests to determine whether the analyses constitute an innovative exploration of the data, whether the team has resources to complete the request, and whether data will be adequately protected and managed. If issues arise, the PIs and research team will negotiate a fair resolution with interested investigators and NIH staff.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 6 months of study completion.
Access Criteria: Data access requests will be reviewed, and requestors will be required to sign a Data Access Agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kayla de la Haye, University of Southern California:
obesity
childhood obesity
maternal and child health
health disparities
prevention
low-income
social network
home environment
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight