Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U54MD012530 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
Not provided
Not provided
Not provided
Not provided
The purpose of this research study is to learn about different approaches to promoting healthy growth among infants, and understanding parents' likes and dislikes of an approach to reducing risk factors for obesity later in life. The study includes filling out some forms with questions about your baby and your thoughts about your baby's growth and health, and engaging in a pattern of changes in or prevention of risk factors in the first year of life. Parents will receive information about changes and some tools and materials to take home with them. Some parents may receive phone calls between visits as well. The study takes place from soon after birth through the infant's age of 9 months. The estimated total time of interaction between the study staff and parents during the study period is 4 hours.
As this is a dyad study, each dyad is considered to be a participant and demographic information will reflect the infant in the dyad, per parent report.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Response | Other |
| |
| Non-response | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard response | Behavioral | Parents pick from a menu of behavior changes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Satisfied or Very Satisfied With Information Given to Them, as Measured by Follow up Questionnaire | Completed Likert scale with 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5=very satisfied | 3 to 6 months after baseline assessment |
| Percentage of Successful Contacts With Families Via Telephone and/or in Clinic | Number of successful contacts with families divided by number of attempts to contact by research staff x 100 | 3 to 6 months after baseline assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants Exclusively Breastfeeding at 4 Months Postnatal Age | Dyad caregivers were asked what type of milk was being consumed by the infant, with 4 options available: 1) Formula only, 2) Mostly formula and some breast milk, 3) Mostly breast milk, but some formula, or 4) Breast milk only. | 3 to 6 months after baseline assessment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Charles Wood | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will be screened for eligibility and if eligible and they consent, complete a questionnaire identifying current potential risks for obesity in infancy. Once one of the three domains is identified, parents will be given scripted educational and supportive messaging relevant to the domain.
Participants are recruited as caregiver/child dyads.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard Response Caregiver/Child Dyad - Caregiver | Standard response: Parents pick from a menu of behavior changes |
| FG001 | Standard Response Caregiver/Child Dyad - Child | Standard response: Parents pick from a menu of behavior changes |
| FG002 | Targeted Response Caregiver/Child Dyad - Caregiver | Targeted response: Stepped up phone interaction with parents based on menu of behavior changes |
| FG003 | Targeted Response Caregiver/Child Dyad - Child | Targeted response: Stepped up phone interaction with parents based on menu of behavior changes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Demographic information was not collected on parents/caregivers. The unit of analysis was the dyad, with demographic information reflecting the parent-reported demographics of their infant only.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Response Caregiver/Child Dyad - Child | Standard response: Parents pick from a menu of behavior changes |
| BG001 | Targeted Response Caregiver/Child Dyad - Child | Targeted response: Stepped up phone interaction with parents based on menu of behavior changes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Satisfied or Very Satisfied With Information Given to Them, as Measured by Follow up Questionnaire | Completed Likert scale with 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5=very satisfied | Caregiver/child dyads who completed the study. | Posted | Count of Participants | Participants | 3 to 6 months after baseline assessment |
|
Approximately 7 months
Participants are treated as dyad, but adverse events refer to infant only. Adverse events were not collected for caregivers.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Response Caregiver/Child Dyad - Child | Standard response: Dyads pick from a menu of behavior changes |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles Wood | Duke University | 919-620-4772 | charles.wood@duke.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 27, 2020 | Jul 21, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 3, 2020 | Jul 21, 2022 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Targeted response |
| Behavioral |
Stepped up phone interaction with parents based on menu of behavior changes |
|
| Percent of Participants Delaying Complementary Feeding Until 4 Months Postnatal Age | Dyads caregivers were asked, "Is your baby eating solid foods yet or do you put any solid foods in the bottle?", with 2 options available: 1) Yes or 2) No | 3 to 6 months after baseline assessment |
| Percent of Participants Reporting "Never" Engaging in Screentime While Feeding and With '0' Minutes of Active TV Watching at 4 Months Postnatal Age | Dyad caregivers were asked "I watch TV or look at or use my phone while feeding my baby" and responded with one of 5 Likert-scale responses: 1) Never, 2) Seldom, 3) Half of the time, 4) Most of the time, 5) Always | 3 to 6 months after baseline assessment |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Percentage of Successful Contacts With Families Via Telephone and/or in Clinic | Number of successful contacts with families divided by number of attempts to contact by research staff x 100 | Participants with data collected. | Posted | Number | percentage of contacts | 3 to 6 months after baseline assessment |
|
|
|
| Secondary | Percent of Participants Exclusively Breastfeeding at 4 Months Postnatal Age | Dyad caregivers were asked what type of milk was being consumed by the infant, with 4 options available: 1) Formula only, 2) Mostly formula and some breast milk, 3) Mostly breast milk, but some formula, or 4) Breast milk only. | Participants with data collected. | Posted | Number | percentage of participants | 3 to 6 months after baseline assessment |
|
|
|
| Secondary | Percent of Participants Delaying Complementary Feeding Until 4 Months Postnatal Age | Dyads caregivers were asked, "Is your baby eating solid foods yet or do you put any solid foods in the bottle?", with 2 options available: 1) Yes or 2) No | Participants with data collected. | Posted | Number | percentage of participants | 3 to 6 months after baseline assessment |
|
|
|
| Secondary | Percent of Participants Reporting "Never" Engaging in Screentime While Feeding and With '0' Minutes of Active TV Watching at 4 Months Postnatal Age | Dyad caregivers were asked "I watch TV or look at or use my phone while feeding my baby" and responded with one of 5 Likert-scale responses: 1) Never, 2) Seldom, 3) Half of the time, 4) Most of the time, 5) Always | Participants with data collected. | Posted | Number | percentage of participants | 3 to 6 months after baseline assessment |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Targeted Response Caregiver/Child Dyad - Child | Targeted response: Stepped up phone interaction with dyads based on menu of behavior changes | 0 | 7 | 0 | 7 | 0 | 7 |
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |