Obesity
Conditions
Keywords
infant, mother-baby
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALStandard response
Parents pick from a menu of behavior changes
BEHAVIORALTargeted response
Stepped up phone interaction with parents based on menu of behavior changes
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Weeks to 2 Months
Healthy volunteers
Yes
Inclusion criteria
* Non-Hispanic black (as documented in MaestroCare) parents/caregivers with; infants ages 2 weeks to 2 months of age; infant birthweight between 2500g and 4000g; infant gestational age is at least 36 weeks
Exclusion criteria
* non-English-speaking; infant with serious disease or disorder affecting growth and nutrition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Satisfied or Very Satisfied With Information Given to Them, as Measured by Follow up Questionnaire | 3 to 6 months after baseline assessment | Completed Likert scale with 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5=very satisfied |
| Percentage of Successful Contacts With Families Via Telephone and/or in Clinic | 3 to 6 months after baseline assessment | Number of successful contacts with families divided by number of attempts to contact by research staff x 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Exclusively Breastfeeding at 4 Months Postnatal Age | 3 to 6 months after baseline assessment | 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. |
| Percent of Participants Delaying Complementary Feeding Until 4 Months Postnatal Age | 3 to 6 months after baseline assessment | 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 |
| Percent of Participants Reporting Never Engaging in Screentime While Feeding and With '0' Minutes of Active TV Watching at 4 Months Postnatal Age | 3 to 6 months after baseline assessment | 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 |
Countries
United States
Participant flow
Recruitment details
Participants are recruited as caregiver/child dyads.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| Standard Response Caregiver/Child Dyad - Child Standard response: Parents pick from a menu of behavior changes | 7 |
| Targeted Response Caregiver/Child Dyad - Child Targeted response: Stepped up phone interaction with parents based on menu of behavior changes | 7 |
| Total | 14 |
Baseline characteristics
| Characteristic | Targeted Response Caregiver/Child Dyad - Child | Total | Standard Response Caregiver/Child Dyad - Child |
|---|---|---|---|
| Age, Categorical <=18 years | 7 Participants | 14 Participants | 7 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 1 months STANDARD_DEVIATION 1.3 | 1 months STANDARD_DEVIATION 1.2 | 1 months STANDARD_DEVIATION 1.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 14 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 7 Participants | 14 Participants | 7 Participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
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
Time frame: 3 to 6 months after baseline assessment
Population: Caregiver/child dyads who completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Response Caregiver/Child Dyads | Number of Participants Satisfied or Very Satisfied With Information Given to Them, as Measured by Follow up Questionnaire | 4 Participants |
| Targeted Response Caregiver/Child Dyads | Number of Participants Satisfied or Very Satisfied With Information Given to Them, as Measured by Follow up Questionnaire | 2 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
Time frame: 3 to 6 months after baseline assessment
Population: Participants with data collected.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Response Caregiver/Child Dyads | Percentage of Successful Contacts With Families Via Telephone and/or in Clinic | 85.8 percentage of contacts |
| Targeted Response Caregiver/Child Dyads | Percentage of Successful Contacts With Families Via Telephone and/or in Clinic | 100 percentage of contacts |
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
Time frame: 3 to 6 months after baseline assessment
Population: Participants with data collected.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Response Caregiver/Child Dyads | Percent of Participants Delaying Complementary Feeding Until 4 Months Postnatal Age | 71.4 percentage of participants |
| Targeted Response Caregiver/Child Dyads | Percent of Participants Delaying Complementary Feeding Until 4 Months Postnatal Age | 33.3 percentage of participants |
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.
Time frame: 3 to 6 months after baseline assessment
Population: Participants with data collected.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Response Caregiver/Child Dyads | Percent of Participants Exclusively Breastfeeding at 4 Months Postnatal Age | 71.4 percentage of participants |
| Targeted Response Caregiver/Child Dyads | Percent of Participants Exclusively Breastfeeding at 4 Months Postnatal Age | 33.3 percentage of participants |
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
Time frame: 3 to 6 months after baseline assessment
Population: Participants with data collected.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Response Caregiver/Child Dyads | Percent of Participants Reporting Never Engaging in Screentime While Feeding and With '0' Minutes of Active TV Watching at 4 Months Postnatal Age | 42.9 percentage of participants |
| Targeted Response Caregiver/Child Dyads | Percent of Participants Reporting Never Engaging in Screentime While Feeding and With '0' Minutes of Active TV Watching at 4 Months Postnatal Age | 100 percentage of participants |