Trial Outcomes & Findings for Quincy Family, Youth & Technology For Lifestyle Change (FYT-4-LIFE) Study (NCT NCT02324361)
NCT ID: NCT02324361
Last Updated: 2020-10-22
Results Overview
We designed a scale for use in this study containing 8 questions on each of the family routines that we assessed (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep hours). Each of the eight questions were assigned one point value. The scale was summative such that the lowest possible score was 0 and highest possible score was 8, from adding up scores to all eight questions. Higher scores indicated a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
90 days
Results posted on
2020-10-22
Participant Flow
From July to October 2014, attempts were made to solicit the participation of primary caregivers of all children receiving care since 2013 at Quincy Pediatric Associates (QPA) via mailed recruitment letters.
Caregivers were phone-screened for English fluency, internet access, computer/smartphone ownership, and ownership of a Facebook account. Those with significant functional impairments or co-morbidities, those enrolled in another weight management intervention program, or had a sibling already enrolled in the study were excluded from participation.
Participant milestones
| Measure |
Facebook Group
The intervention arm consists of evidence-based information on healthy family routines and parenting strategies (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep) adapted for Facebook posts on a private study Facebook group.
All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study.
|
Text Messaging (SMS) Group
The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages.
The automated text-messaging algorithm consists two types of messaging: 1-way messages containing education or motivation on the dimension topic that one is being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on.
All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
19
|
22
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Facebook Group
The intervention arm consists of evidence-based information on healthy family routines and parenting strategies (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep) adapted for Facebook posts on a private study Facebook group.
All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study.
|
Text Messaging (SMS) Group
The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages.
The automated text-messaging algorithm consists two types of messaging: 1-way messages containing education or motivation on the dimension topic that one is being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on.
All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
Baseline Characteristics
Quincy Family, Youth & Technology For Lifestyle Change (FYT-4-LIFE) Study
Baseline characteristics by cohort
| Measure |
Facebook Group
n=23 Participants
The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for Facebook posts on a private study Facebook group.
Participating parents/guardians will have access to all features of the secret study Facebook group (e.g., create and view postings, comment and like existing posts and view user names of other members of the group (existing study participants and staff) for the duration of the study.
All index children will be provided with a Physical Activity Monitor to wear during waking hours for the duration of the study.
|
Text Messaging
n=24 Participants
The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages.
The automated text-messaging algorithm consists of the delivery of two types of text messages: 1-way messages, in which participating parents/guardians will receive a piece of education or motivation on the dimension topic that they're being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.9 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
5.3 years
STANDARD_DEVIATION 1.3 • n=7 Participants
|
5.0 years
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 daysWe designed a scale for use in this study containing 8 questions on each of the family routines that we assessed (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep hours). Each of the eight questions were assigned one point value. The scale was summative such that the lowest possible score was 0 and highest possible score was 8, from adding up scores to all eight questions. Higher scores indicated a better outcome.
Outcome measures
| Measure |
Facebook Group
n=23 Participants
The intervention arm consists of evidence-based information on healthy family routines and parenting strategies (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep) adapted for Facebook posts on a private study Facebook group.
All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study.
|
Text Messaging (SMS) Group
n=24 Participants
The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages.
The automated text-messaging algorithm consists two types of messaging: 1-way messages containing education or motivation on the dimension topic that one is being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on.
All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study.
|
|---|---|---|
|
Parent/Guardian Knowledge of Healthy Family Routines and of Parenting Strategies That Are Preventive of Child Overweight and Obesity
|
1.2 units on a scale
Interval 0.6 to 1.7
|
0.9 units on a scale
Interval 0.2 to 1.6
|
SECONDARY outcome
Timeframe: 90 daysBaseline to 90-days post-intervention change in child sleep duration (hours per day)
Outcome measures
| Measure |
Facebook Group
n=23 Participants
The intervention arm consists of evidence-based information on healthy family routines and parenting strategies (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep) adapted for Facebook posts on a private study Facebook group.
All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study.
|
Text Messaging (SMS) Group
n=24 Participants
The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages.
The automated text-messaging algorithm consists two types of messaging: 1-way messages containing education or motivation on the dimension topic that one is being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on.
All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study.
|
|---|---|---|
|
Change in Sleep
|
0.3 hours per day
Interval -0.8 to 0.7
|
0.3 hours per day
Interval 0.0 to 0.5
|
SECONDARY outcome
Timeframe: 90 daysBaseline to 90-days post-intervention change in child screen time exposure (hours per day)
Outcome measures
| Measure |
Facebook Group
n=23 Participants
The intervention arm consists of evidence-based information on healthy family routines and parenting strategies (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep) adapted for Facebook posts on a private study Facebook group.
All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study.
|
Text Messaging (SMS) Group
n=24 Participants
The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages.
The automated text-messaging algorithm consists two types of messaging: 1-way messages containing education or motivation on the dimension topic that one is being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on.
All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study.
|
|---|---|---|
|
Change in Child Screen Time Exposure
|
-0.7 hours per day
Interval -1.5 to 0.1
|
-0.4 hours per day
Interval -1.1 to 0.4
|
SECONDARY outcome
Timeframe: 90 daysBaseline to 90-days post-intervention change in child sugar sweetened beverage intake (servings per day)
Outcome measures
| Measure |
Facebook Group
n=23 Participants
The intervention arm consists of evidence-based information on healthy family routines and parenting strategies (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep) adapted for Facebook posts on a private study Facebook group.
All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study.
|
Text Messaging (SMS) Group
n=24 Participants
The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages.
The automated text-messaging algorithm consists two types of messaging: 1-way messages containing education or motivation on the dimension topic that one is being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on.
All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study.
|
|---|---|---|
|
Change in Sugar Sweetened Beverage Intake
|
-0.1 servings per day
Interval -0.3 to 0.2
|
-0.4 servings per day
Interval -0.8 to 0.0
|
Adverse Events
Facebook Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Text Messaging (SMS) Group
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