ObesityNCT03529695
In-home Obesity Prevention to Reach Low-income Infants
A study testing Standard HVP Curriculum and Obesity Prevention in people with Obesity and Obesity, Childhood, run by University of Southern California at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 months and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Obesity, Childhood, Obesity; Familial
- What is being tested?
- Standard HVP Curriculum and Obesity Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 31 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089-9239
About this study
Official title: In-home Obesity Prevention to Reach Low-income Infants Through Maternal and Social Transmission
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.
Read the detailed description
More than 40% of children enrolled in federally funded programs are overweight or obese by age 5. Unfortunately, extant obesity efforts have had a limited impact among low-income underserved children, in part because of limitations inherent to existing programs: 1) short duration and low intensity; 2) late timing of implementation, when children are already overweight or obese; 3) delivery methods limiting their accessibility and sustainability; and 4) failure to address barriers such as a lack of culturally competent services, poverty, housing instability, and access to care, which interfere with healthy lifestyle changes. To address these gaps, we have integrated simple, evidence-based nutrition and physical activity components as part of the services already delivered by our home visitation partner, Healthy Families America, with the long-term goal to deploy these efforts to Home Visitation Programs (HVPs) nationwide. Annually, over 500 publicly and privately funded HVPs provide nationwide services to more than 650,000 low-income, underserved infants and their families. The home visiting structure is not only an unparalleled model for scalable and sustainable childhood obesity prevention, but it also provides a unique opportunity to understand factors related to the intergenerational transmission of obesity in families who are most at risk.
Over the last four years, our transdisciplinary team of researchers, home visiting stakeholders, families, and community stakeholders has integrated evidence-based nutrition and physical activity components into an engaging obesity prevention curriculum delivered in English and Spanish as an enhancement module to the services of our HVP partner. Our pilot work supports the successful integration, feasibility, and preliminary efficacy of integrating obesity prevention as part of HVP services. The proposed study tests the large-scale and sustained impact of home-based obesity prevention on infant's and mothers' obesity outcomes, and studies key mechanisms of maternal and social transmission on infants' obesity risk.
Specifically, 300 low-income mothers/infants enrolled in Healthy Families America's HVP will be recruited and enrolled in the study. Based on standard HVP procedures, mothers/infants will be matched to highly trained home visitors based on their ethnicity/race and language preferences. Home visitors, in turn, will be randomly assigned to deliver the standard HVP curriculum only or the standard HVP curriculum + obesity prevention as part of their weekly home visits, for the first 12 months of HVP services. Comprehensive assessments of mothers/infants will be conducted at enrollment and after 6 and 12 months of intervention.
Aim 1 (maternal and infant outcomes). Test the direct effects of obesity prevention on infants and mothers' weight, metabolic risks, diet/energy intake, and physical activity. This will be accomplished by comparing changes in body weight, metabolic markers, and eating and activity-related behaviors between infants/mothers across study arms (HVP only vs. HVP+obesity prevention). These results will indicate whether HVP is an effective infrastructure for primary and secondary obesity prevention.
Aim 2 (maternal transmission). Test whether breastfeeding and maternal diet and activity, feeding practices, and food insecurity mediate the effect of obesity prevention on infants' outcomes. This aim will test mechanisms of maternal transmission on infants' obesity risks.
Aim 3 (social transmission). Aim 3 is two-pronged. Aim 3a tests the direct effect of HVP+obesity prevention (vs. HVP only) on the characteristics of the social and community networks that surround mothers and infants (i.e., the density, composition, and quality of health support networks). Aim 3b tests whether the characteristics of social networks mediate the effects of obesity prevention on maternal and infant outcomes. These findings will indicate if the delivery of in-home obesity prevention efforts can alter and/or activate social network mechanisms.
Secondary Aim. Conduct a real-life economic analysis (costs, cost-savings, and non-monetary benefits) of integrating obesity prevention into existing HVPs.
This proposal addresses the impetus to develop interventions targeting at-risk infants before obesity is established. Although maternal-infant interventions are much-needed, they present implementation and dissemination challenges, including limitations on compliance and retention, and limited potential for scalability and sustainability. Our proposed strategy overcomes these challenges through an innovative solution that merges evidence-based nutrition and activity components into an existing, ongoing federally-funded infrastructure. The proposed research is timely as the Institute of Medicine, the United States Department of Agriculture, and Health and Human Services (DHHS) extend their recommendations to address key factors influencing obesity risk in children from birth to 24 months of age.
- Conditions
- Obesity, Obesity, Childhood, Obesity; Familial
- Being tested
- Standard HVP Curriculum, Obesity Prevention
- Keywords
- obesity, childhood obesity, maternal and child health, health disparities, prevention, low-income, social network, home environment
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard HVP CurriculumBehavioural
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.
Obesity PreventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard HVP Curriculum | Active comparator | 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. Receives: Behavioral: Standard HVP Curriculum |
| Obesity Prevention | Experimental | 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. Receives: Behavioral: Standard HVP Curriculum; Behavioral: Obesity Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother BMI
Body mass index (BMI) at each assessment
Measured: Baseline, 6 months, 12 months
Infant Weight
weight in pounds
Measured: Baseline, 6 months, 12 months
Secondary outcomes (7)
Fruit Intake Frequency
Assessed using modified food frequency measures from the National Health and Nutrition Examination Survey (NHANES).
Measured: Baseline, 6 months, 12 months
Vegetable Intake Frequency
Assessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)
Measured: Baseline, 6 months, 12 months
Fried Food Intake Frequency
Assessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)
Measured: Baseline, 6 months, 12 months
Soda Intake Frequency
Assessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)
Measured: Baseline, 6 months, 12 months
Fruit Juice Intake Frequency
Assessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)
Measured: Baseline, 6 months, 12 months
Mother Movement Frequency
Assessed using modified activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)
Measured: Baseline, 6 months, 12 months
Frequency of Infant Supervised Active Movement (Activity)
Assessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start1 Nov 2018
- Primary completion30 Jan 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Antelope Valley Partners for Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Cedars-Sinai Medical Center
- Responsible party
- Principal investigator, Kayla de la Haye, University of Southern California
- Investigators
- Kayla de la Haye, PhD, Principal investigator, University of Southern CaliforniaSarah-Jeanne Salvy, PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529695
- Sponsor's protocol ID
- 1R01HD092483-01
- Other IDs
- 1R01HD092483-01
- Status last verified
- Oct 2024
- First submitted
- 20 Apr 2018
- Last updated
- 23 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Development, execution, and data collection for this study is completed with a Principle Investigator at Cedars-Sinai Medical Center. 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.
Publications
de la Haye K, Fluke M, Laney PC, Goran M, Galama T, Chou CP, Salvy SJ. In-home obesity prevention in low-income infants through maternal and social transmission. Contemp Clin Trials. 2019 Feb;77:61-69. doi: 10.1016/j.cct.2018.12.010. Epub 2018 Dec 19.
PubMed 30578850
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-home Obesity Prevention to Reach Low-income Infants Through Maternal and Social Transmission
- ClinicalTrials.gov ID
- NCT03529695
- Acronym / sponsor ID
- 1R01HD092483-01
- Conditions
- Obesity, Obesity, Childhood, Obesity; Familial
- Keywords
- obesity, childhood obesity, maternal and child health, health disparities, prevention, low-income, social network, home environment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Antelope Valley Partners for Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Cedars-Sinai Medical Center
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Posted 23 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
More than 40% of children enrolled in federally funded programs are overweight or obese by age 5. Unfortunately, extant obesity efforts have had a limited impact among low-income underserved children, in part because of limitations inherent to existing programs: 1) short duration and low intensity; 2) late timing of implementation, when children are already overweight or obese; 3) delivery methods limiting their accessibility and sustainability; and 4) failure to address barriers such as a lack of culturally competent services, poverty, housing instability, and access to care, which interfere with healthy lifestyle changes. To address these gaps, we have integrated simple, evidence-based nutrition and physical activity components as part of the services already delivered by our home visitation partner, Healthy Families America, with the long-term goal to deploy these efforts to Home Visitation Programs (HVPs) nationwide. Annually, over 500 publicly and privately funded HVPs provide nationwide services to more than 650,000 low-income, underserved infants and their families. The home visiting structure is not only an unparalleled model for scalable and sustainable childhood obesity prevention, but it also provides a unique opportunity to understand factors related to the intergenerational transmission of obesity in families who are most at risk.
Over the last four years, our transdisciplinary team of researchers, home visiting stakeholders, families, and community stakeholders has integrated evidence-based nutrition and physical activity components into an engaging obesity prevention curriculum delivered in English and Spanish as an enhancement module to the services of our HVP partner. Our pilot work supports the successful integration, feasibility, and preliminary efficacy of integrating obesity prevention as part of HVP services. The proposed study tests the large-scale and sustained impact of home-based obesity prevention on infant's and mothers' obesity outcomes, and studies key mechanisms of maternal and social transmission on infants' obesity risk.
Specifically, 300 low-income mothers/infants enrolled in Healthy Families America's HVP will be recruited and enrolled in the study. Based on standard HVP procedures, mothers/infants will be matched to highly trained home visitors based on their ethnicity/race and language preferences. Home visitors, in turn, will be randomly assigned to deliver the standard HVP curriculum only or the standard HVP curriculum + obesity prevention as part of their weekly home visits, for the first 12 months of HVP services. Comprehensive assessments of mothers/infants will be conducted at enrollment and after 6 and 12 months of intervention.
Aim 1 (maternal and infant outcomes). Test the direct effects of obesity prevention on infants and mothers' weight, metabolic risks, diet/energy intake, and physical activity. This will be accomplished by comparing changes in body weight, metabolic markers, and eating and activity-related behaviors between infants/mothers across study arms (HVP only vs. HVP+obesity prevention). These results will indicate whether HVP is an effective infrastructure for primary and secondary obesity prevention.
Aim 2 (maternal transmission). Test whether breastfeeding and maternal diet and activity, feeding practices, and food insecurity mediate the effect of obesity prevention on infants' outcomes. This aim will test mechanisms of maternal transmission on infants' obesity risks.
Aim 3 (social transmission). Aim 3 is two-pronged. Aim 3a tests the direct effect of HVP+obesity prevention (vs. HVP only) on the characteristics of the social and community networks that surround mothers and infants (i.e., the density, composition, and quality of health support networks). Aim 3b tests whether the characteristics of social networks mediate the effects of obesity prevention on maternal and infant outcomes. These findings will indicate if the delivery of in-home obesity prevention efforts can alter and/or activate social network mechanisms.
Secondary Aim. Conduct a real-life economic analysis (costs, cost-savings, and non-monetary benefits) of integrating obesity prevention into existing HVPs.
This proposal addresses the impetus to develop interventions targeting at-risk infants before obesity is established. Although maternal-infant interventions are much-needed, they present implementation and dissemination challenges, including limitations on compliance and retention, and limited potential for scalability and sustainability. Our proposed strategy overcomes these challenges through an innovative solution that merges evidence-based nutrition and activity components into an existing, ongoing federally-funded infrastructure. The proposed research is timely as the Institute of Medicine, the United States Department of Agriculture, and Health and Human Services (DHHS) extend their recommendations to address key factors influencing obesity risk in children from birth to 24 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard HVP Curriculum | Active comparator | Behavioral: Standard HVP CurriculumParticipants 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. |
| Obesity Prevention | Experimental | Behavioral: Standard HVP Curriculum, Behavioral: Obesity PreventionParticipants 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. |
Who may qualify
- Ages
- 2 months and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Enrolled in a partnered home visitation program
- Mother or primary caregiver of 2-8 month old child
- BMI above 18.5
- Generally Healthy
- 2-8 months of age at time of enrollment
Key exclusion criteria (6 listed)
- 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.
- Infant is clinically underweight (<5th percentile) or has a history of a feeding or eating disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard HVP CurriculumTreatment 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. | Behavioural | Obesity Prevention, Standard HVP Curriculum |
| Obesity PreventionObesity 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. | Behavioural | Obesity Prevention |
Primary outcome
Mother BMI
Time frame: Baseline, 6 months, 12 months
Body mass index (BMI) at each assessment
Infant Weight
Time frame: Baseline, 6 months, 12 months
weight in pounds
7 secondary outcomes
Fruit Intake Frequency
Time frame: Baseline, 6 months, 12 months
Vegetable Intake Frequency
Time frame: Baseline, 6 months, 12 months
Fried Food Intake Frequency
Time frame: Baseline, 6 months, 12 months
Soda Intake Frequency
Time frame: Baseline, 6 months, 12 months
Fruit Juice Intake Frequency
Time frame: Baseline, 6 months, 12 months
Mother Movement Frequency
Time frame: Baseline, 6 months, 12 months
Frequency of Infant Supervised Active Movement (Activity)
Time frame: Baseline, 6 months, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30578850de la Haye K, Fluke M, Laney PC, Goran M, Galama T, Chou CP, Salvy SJ. In-home obesity prevention in low-income infants through maternal and social transmission. Contemp Clin Trials. 2019 Feb;77:61-69. doi: 10.1016/j.cct.2018.12.010. Epub 2018 Dec 19.
- Individual participant dataSharing planned: Yes. Development, execution, and data collection for this study is completed with a Principle Investigator at Cedars-Sinai Medical Center. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kayla de la Haye, PhD principal investigator
University of Southern California
Sarah-Jeanne Salvy, PhD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard HVP Curriculum and Obesity Prevention in people with Obesity and Obesity, Childhood, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mother BMI (time frame: Baseline, 6 months, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03529695, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.