Trial Outcomes & Findings for Feasibility of Healthy Dads Healthy Kids Latino (NCT NCT03532048)
NCT ID: NCT03532048
Last Updated: 2021-03-03
Results Overview
Retain 80% of intervention and control participants for pre- and post-assessments
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
160 participants
Primary outcome timeframe
5 months
Results posted on
2021-03-03
Participant Flow
Goal of 40 families (160 individuals) to be recruited.
Unit of analysis: families
Participant milestones
| Measure |
Intervention Group
The Papás Saludables, Niños Saludables Program
The Papás Saludables, Niños Saludables Program: Papás Saludables, Niños Saludables is a 10 week program for fathers and their children that meets weekly. Each session is 90 minutes long: 15 min introduction, 30 min pull-out sessions for fathers and children, and 45 min active play sessions together. Fathers are encouraged to improve their eating and physical behaviors to lose weight and to be healthy role models for their child. Children are encouraged to help their fathers lose weight and improve their health. The program has been adapted to contextualize the information for low-income Hispanic families and changed to US food and physical activity guidelines. Mothers will be provided a Handbook and will be sent short videos, recipe links, and short motivational messages every week covering the same topics as in the sessions.
|
Wait-list Control
The Papás Saludables, Niños Saludables Wait-list Control
The Papás Saludables, Niños Saludables Wait-list Control: The same program as above delivered to the wait-list control after the T1 follow-up data has been collected.
|
|---|---|---|
|
Overall Study
STARTED
|
68 19
|
67 17
|
|
Overall Study
COMPLETED
|
49 14
|
50 13
|
|
Overall Study
NOT COMPLETED
|
19 5
|
17 4
|
Reasons for withdrawal
| Measure |
Intervention Group
The Papás Saludables, Niños Saludables Program
The Papás Saludables, Niños Saludables Program: Papás Saludables, Niños Saludables is a 10 week program for fathers and their children that meets weekly. Each session is 90 minutes long: 15 min introduction, 30 min pull-out sessions for fathers and children, and 45 min active play sessions together. Fathers are encouraged to improve their eating and physical behaviors to lose weight and to be healthy role models for their child. Children are encouraged to help their fathers lose weight and improve their health. The program has been adapted to contextualize the information for low-income Hispanic families and changed to US food and physical activity guidelines. Mothers will be provided a Handbook and will be sent short videos, recipe links, and short motivational messages every week covering the same topics as in the sessions.
|
Wait-list Control
The Papás Saludables, Niños Saludables Wait-list Control
The Papás Saludables, Niños Saludables Wait-list Control: The same program as above delivered to the wait-list control after the T1 follow-up data has been collected.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
17
|
|
Overall Study
Withdrawal by Subject
|
7
|
0
|
Baseline Characteristics
Age reported separately for fathers and children. Age was not collected on the mothers.
Baseline characteristics by cohort
| Measure |
Intervention Group
n=19 families
The Papás Saludables, Niños Saludables Program
The Papás Saludables, Niños Saludables Program: Papás Saludables, Niños Saludables is a 10 week program for fathers and their children that meets weekly. Each session is 90 minutes long: 15 min introduction, 30 min pull-out sessions for fathers and children, and 45 min active play sessions together. Fathers are encouraged to improve their eating and physical behaviors to lose weight and to be healthy role models for their child. Children are encouraged to help their fathers lose weight and improve their health. The program has been adapted to contextualize the information for low-income Hispanic families and changed to US food and physical activity guidelines. Mothers will be provided a Handbook and will be sent short videos, recipe links, and short motivational messages every week covering the same topics as in the sessions.
|
Wait-list Control
n=17 families
The Papás Saludables, Niños Saludables Wait-list Control
The Papás Saludables, Niños Saludables Wait-list Control: The same program as above delivered to the wait-list control after the T1 follow-up data has been collected.
|
Total
n=36 families
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Fathers
|
36.8 years
STANDARD_DEVIATION 7.61 • n=19 Participants • Age reported separately for fathers and children. Age was not collected on the mothers.
|
36.1 years
STANDARD_DEVIATION 5.25 • n=17 Participants • Age reported separately for fathers and children. Age was not collected on the mothers.
|
36.5 years
STANDARD_DEVIATION 6.52 • n=36 Participants • Age reported separately for fathers and children. Age was not collected on the mothers.
|
|
Age, Continuous
Children
|
8.8 years
STANDARD_DEVIATION 2.26 • n=31 Participants • Age reported separately for fathers and children. Age was not collected on the mothers.
|
8.1 years
STANDARD_DEVIATION 1.96 • n=33 Participants • Age reported separately for fathers and children. Age was not collected on the mothers.
|
8.5 years
STANDARD_DEVIATION 2.12 • n=64 Participants • Age reported separately for fathers and children. Age was not collected on the mothers.
|
|
Age, Continuous
Mothers
|
NA years
STANDARD_DEVIATION NA • n=18 Participants • Age reported separately for fathers and children. Age was not collected on the mothers.
|
NA years
STANDARD_DEVIATION NA • n=17 Participants • Age reported separately for fathers and children. Age was not collected on the mothers.
|
NA years
STANDARD_DEVIATION NA • n=35 Participants • Age reported separately for fathers and children. Age was not collected on the mothers.
|
|
Sex: Female, Male
Female
|
34 Participants
n=68 Participants
|
37 Participants
n=67 Participants
|
71 Participants
n=135 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=68 Participants
|
30 Participants
n=67 Participants
|
64 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Hispanic : Fathers
|
19 Participants
n=68 Participants
|
17 Participants
n=67 Participants
|
36 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Hispanic : Children
|
NA Participants
n=68 Participants
|
NA Participants
n=67 Participants
|
NA Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Hispanic : Mothers
|
NA Participants
n=68 Participants
|
NA Participants
n=67 Participants
|
NA Participants
n=135 Participants
|
PRIMARY outcome
Timeframe: 5 monthsPopulation: families
Retain 80% of intervention and control participants for pre- and post-assessments
Outcome measures
| Measure |
Intervention Group
n=19 families
The Papás Saludables, Niños Saludables Program
The Papás Saludables, Niños Saludables Program: Papás Saludables, Niños Saludables is a 10 week program for fathers and their children that meets weekly. Each session is 90 minutes long: 15 min introduction, 30 min pull-out sessions for fathers and children, and 45 min active play sessions together. Fathers are encouraged to improve their eating and physical behaviors to lose weight and to be healthy role models for their child. Children are encouraged to help their fathers lose weight and improve their health. The program has been adapted to contextualize the information for low-income Hispanic families and changed to US food and physical activity guidelines. Mothers will be provided a Handbook and will be sent short videos, recipe links, and short motivational messages every week covering the same topics as in the sessions.
|
Wait-list Control
n=17 families
The Papás Saludables, Niños Saludables Wait-list Control
The Papás Saludables, Niños Saludables Wait-list Control: The same program as above delivered to the wait-list control after the T1 follow-up data has been collected.
|
|---|---|---|
|
Retention of Subjects in Study Assessments
|
14 families
|
13 families
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: The goal was to recruit 40 families (20 for intervention group and 20 for wait-list control group) in \</=4 months.
Recruitment criteria was to recruit 40 Latino fathers and their families in ≤ 4 months. The actual recruited number of fathers with their family is reported as the outcome withe the percentage of goal achieved (actual/goal).
Outcome measures
| Measure |
Intervention Group
n=20 families
The Papás Saludables, Niños Saludables Program
The Papás Saludables, Niños Saludables Program: Papás Saludables, Niños Saludables is a 10 week program for fathers and their children that meets weekly. Each session is 90 minutes long: 15 min introduction, 30 min pull-out sessions for fathers and children, and 45 min active play sessions together. Fathers are encouraged to improve their eating and physical behaviors to lose weight and to be healthy role models for their child. Children are encouraged to help their fathers lose weight and improve their health. The program has been adapted to contextualize the information for low-income Hispanic families and changed to US food and physical activity guidelines. Mothers will be provided a Handbook and will be sent short videos, recipe links, and short motivational messages every week covering the same topics as in the sessions.
|
Wait-list Control
n=20 families
The Papás Saludables, Niños Saludables Wait-list Control
The Papás Saludables, Niños Saludables Wait-list Control: The same program as above delivered to the wait-list control after the T1 follow-up data has been collected.
|
|---|---|---|
|
Recruitment of Subjects Into Study
|
19 families
|
17 families
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: Families were the unit of analysis
Attendance of families to the 10 PSNS program sessions were recorded each week for the intervention group and later the wait-list control group. The goals was to maintain ≥70% attendance to program sessions
Outcome measures
| Measure |
Intervention Group
n=19 families
The Papás Saludables, Niños Saludables Program
The Papás Saludables, Niños Saludables Program: Papás Saludables, Niños Saludables is a 10 week program for fathers and their children that meets weekly. Each session is 90 minutes long: 15 min introduction, 30 min pull-out sessions for fathers and children, and 45 min active play sessions together. Fathers are encouraged to improve their eating and physical behaviors to lose weight and to be healthy role models for their child. Children are encouraged to help their fathers lose weight and improve their health. The program has been adapted to contextualize the information for low-income Hispanic families and changed to US food and physical activity guidelines. Mothers will be provided a Handbook and will be sent short videos, recipe links, and short motivational messages every week covering the same topics as in the sessions.
|
Wait-list Control
n=17 families
The Papás Saludables, Niños Saludables Wait-list Control
The Papás Saludables, Niños Saludables Wait-list Control: The same program as above delivered to the wait-list control after the T1 follow-up data has been collected.
|
|---|---|---|
|
Subject Attendance to Program Sessions
|
5.6 sessions attended
Standard Deviation 4.1
|
5.6 sessions attended
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: parent (fathers and mothers) who reported "excellent" or "good" on 5-point scale.
The participating Latino fathers will be satisfied with the program as measured by 80% 'excellent'-'good' satisfaction from questionnaires and exit interviews with the Latino fathers and their co-parent (typically children's mother).
Outcome measures
| Measure |
Intervention Group
n=24 Participants
The Papás Saludables, Niños Saludables Program
The Papás Saludables, Niños Saludables Program: Papás Saludables, Niños Saludables is a 10 week program for fathers and their children that meets weekly. Each session is 90 minutes long: 15 min introduction, 30 min pull-out sessions for fathers and children, and 45 min active play sessions together. Fathers are encouraged to improve their eating and physical behaviors to lose weight and to be healthy role models for their child. Children are encouraged to help their fathers lose weight and improve their health. The program has been adapted to contextualize the information for low-income Hispanic families and changed to US food and physical activity guidelines. Mothers will be provided a Handbook and will be sent short videos, recipe links, and short motivational messages every week covering the same topics as in the sessions.
|
Wait-list Control
n=23 Participants
The Papás Saludables, Niños Saludables Wait-list Control
The Papás Saludables, Niños Saludables Wait-list Control: The same program as above delivered to the wait-list control after the T1 follow-up data has been collected.
|
|---|---|---|
|
Percentage of Fathers and Mothers Who Reported Their Satisfaction With the PSNS Program as Excellent to Good on the "Healthy Dads Healthy Kids Satisfaction Survey"
|
24 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 5 monthsPopulation: families
Ability to collect anthropometric, behavioral and parenting data on at least 75% of the Latino fathers and anthropometric, and behavioral data on their children (both groups) at baseline and follow up
Outcome measures
| Measure |
Intervention Group
n=19 families
The Papás Saludables, Niños Saludables Program
The Papás Saludables, Niños Saludables Program: Papás Saludables, Niños Saludables is a 10 week program for fathers and their children that meets weekly. Each session is 90 minutes long: 15 min introduction, 30 min pull-out sessions for fathers and children, and 45 min active play sessions together. Fathers are encouraged to improve their eating and physical behaviors to lose weight and to be healthy role models for their child. Children are encouraged to help their fathers lose weight and improve their health. The program has been adapted to contextualize the information for low-income Hispanic families and changed to US food and physical activity guidelines. Mothers will be provided a Handbook and will be sent short videos, recipe links, and short motivational messages every week covering the same topics as in the sessions.
|
Wait-list Control
n=17 families
The Papás Saludables, Niños Saludables Wait-list Control
The Papás Saludables, Niños Saludables Wait-list Control: The same program as above delivered to the wait-list control after the T1 follow-up data has been collected.
|
|---|---|---|
|
Data Collection Completeness
|
13 families
|
13 families
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait-list Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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