Trial Outcomes & Findings for Pattern - Reach Aim 2 (NCT NCT04216264)
NCT ID: NCT04216264
Last Updated: 2022-11-16
Results Overview
Completed Likert scale with 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5=very satisfied
COMPLETED
NA
28 participants
3 to 6 months after baseline assessment
2022-11-16
Participant Flow
Participants are recruited as caregiver/child dyads.
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.
Participant milestones
| Measure |
Standard Response Caregiver/Child Dyad - Caregiver
Standard response: Parents pick from a menu of behavior changes
|
Standard Response Caregiver/Child Dyad - Child
Standard response: Parents pick from a menu of behavior changes
|
Targeted Response Caregiver/Child Dyad - Caregiver
Targeted response: Stepped up phone interaction with parents based on menu of behavior changes
|
Targeted Response Caregiver/Child Dyad - Child
Targeted response: Stepped up phone interaction with parents based on menu of behavior changes
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
7
|
7
|
|
Overall Study
COMPLETED
|
5
|
5
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pattern - Reach Aim 2
Baseline characteristics by cohort
| Measure |
Standard Response Caregiver/Child Dyad - Child
n=7 Participants
Standard response: Parents pick from a menu of behavior changes
|
Targeted Response Caregiver/Child Dyad - Child
n=7 Participants
Targeted response: Stepped up phone interaction with parents based on menu of behavior changes
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
1 months
STANDARD_DEVIATION 1.1 • n=99 Participants
|
1 months
STANDARD_DEVIATION 1.3 • n=107 Participants
|
1 months
STANDARD_DEVIATION 1.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 to 6 months after baseline assessmentPopulation: Caregiver/child dyads who completed the study.
Completed Likert scale with 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5=very satisfied
Outcome measures
| Measure |
Targeted Response Caregiver/Child Dyads
n=2 Participants
Targeted response: Stepped up phone interaction with parents based on menu of behavior changes
|
Standard Response Caregiver/Child Dyads
n=5 Participants
Standard response: Parents pick from a menu of behavior changes
|
|---|---|---|
|
Number of Participants Satisfied or Very Satisfied With Information Given to Them, as Measured by Follow up Questionnaire
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 3 to 6 months after baseline assessmentPopulation: Participants with data collected.
Number of successful contacts with families divided by number of attempts to contact by research staff x 100
Outcome measures
| Measure |
Targeted Response Caregiver/Child Dyads
n=3 Participants
Targeted response: Stepped up phone interaction with parents based on menu of behavior changes
|
Standard Response Caregiver/Child Dyads
n=7 Participants
Standard response: Parents pick from a menu of behavior changes
|
|---|---|---|
|
Percentage of Successful Contacts With Families Via Telephone and/or in Clinic
|
100 percentage of contacts
|
85.8 percentage of contacts
|
SECONDARY outcome
Timeframe: 3 to 6 months after baseline assessmentPopulation: Participants with data collected.
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.
Outcome measures
| Measure |
Targeted Response Caregiver/Child Dyads
n=3 Participants
Targeted response: Stepped up phone interaction with parents based on menu of behavior changes
|
Standard Response Caregiver/Child Dyads
n=7 Participants
Standard response: Parents pick from a menu of behavior changes
|
|---|---|---|
|
Percent of Participants Exclusively Breastfeeding at 4 Months Postnatal Age
|
33.3 percentage of participants
|
71.4 percentage of participants
|
SECONDARY outcome
Timeframe: 3 to 6 months after baseline assessmentPopulation: Participants with data collected.
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
Outcome measures
| Measure |
Targeted Response Caregiver/Child Dyads
n=3 Participants
Targeted response: Stepped up phone interaction with parents based on menu of behavior changes
|
Standard Response Caregiver/Child Dyads
n=7 Participants
Standard response: Parents pick from a menu of behavior changes
|
|---|---|---|
|
Percent of Participants Delaying Complementary Feeding Until 4 Months Postnatal Age
|
33.3 percentage of participants
|
71.4 percentage of participants
|
SECONDARY outcome
Timeframe: 3 to 6 months after baseline assessmentPopulation: Participants with data collected.
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
Outcome measures
| Measure |
Targeted Response Caregiver/Child Dyads
n=3 Participants
Targeted response: Stepped up phone interaction with parents based on menu of behavior changes
|
Standard Response Caregiver/Child Dyads
n=7 Participants
Standard response: Parents pick from a menu of behavior changes
|
|---|---|---|
|
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
|
42.9 percentage of participants
|
Adverse Events
Standard Response Caregiver/Child Dyad - Child
Targeted Response Caregiver/Child Dyad - Child
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place