Trial Outcomes & Findings for Supporting Together Exercise and Play and Improving Nutrition (NCT NCT02724839)
NCT ID: NCT02724839
Last Updated: 2020-11-27
Results Overview
Evaluation of participant attendance in each arm.
COMPLETED
NA
36 participants
Baseline, 3 months
2020-11-27
Participant Flow
A total of 36 parent-child dyads (72 individual participants) were consented and enrolled over the entire course of the study starting with recruitment in February 2016 and ending with the final session in July 2018.
Participant milestones
| Measure |
Biweekly Arm
13 parent-child dyads were enrolled in this arm which convened biweekly.
|
Monthly Arm
12 parent-child dyads were enrolled in this arm which convened monthly.
|
Weekly Arm
8 parent-child dyads were enrolled in this arm which convened weekly.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
11
|
|
Overall Study
COMPLETED
|
12
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
5
|
Reasons for withdrawal
| Measure |
Biweekly Arm
13 parent-child dyads were enrolled in this arm which convened biweekly.
|
Monthly Arm
12 parent-child dyads were enrolled in this arm which convened monthly.
|
Weekly Arm
8 parent-child dyads were enrolled in this arm which convened weekly.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
3
|
Baseline Characteristics
Supporting Together Exercise and Play and Improving Nutrition
Baseline characteristics by cohort
| Measure |
Biweekly Arm
n=12 Participants
The intervention consisted of 6 nutrition group sessions co-led by parent and a professional from the community who rotated at each session. Group nutrition sessions consisted of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson. This is the first of three non-concurrent phases of the study which sought to compare the feasibility and efficacy of the group sessions when offered biweekly (first phase).Parent and child dyads in each arm and phase received a Fitbit Flex wearable device at the second session.
|
Monthly Arm
n=8 Participants
The intervention consisted of 6 nutrition group sessions co-led by parent and a professional from the community who rotated at each session. Group nutrition sessions consisted of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson. This is the second of three non-concurrent phases of the study which sought to compare the feasibility and efficacy of the group sessions when offered monthly (second phase). Parent and child dyads in each arm and phase received a Fitbit Flex wearable device at the second session.
|
Weekly Arm
n=6 Participants
The intervention consisted of 6 nutrition group sessions co-led by parent and a professional from the community who rotated at each session. Group nutrition sessions consisted of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson. This is the third of three non-concurrent phases of the study which sought to compare the feasibility of the group sessions when offered weekly (third phase). For phases one and two participants will participate in only one phase. Due to recruitment issues in the third phase, researchers obtained IRB approval to allow participants from previous phases to participate and instead evaluated feasibility outcomes. Parent and child dyads in each arm and phase received a Fitbit Flex wearable device at the second session.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
<=18 years
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
10 years
STANDARD_DEVIATION 2 • n=5 Participants
|
8 years
STANDARD_DEVIATION 2 • n=7 Participants
|
11 years
STANDARD_DEVIATION 2 • n=5 Participants
|
10 years
STANDARD_DEVIATION 2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsEvaluation of participant attendance in each arm.
Outcome measures
| Measure |
Biweekly Arm
n=12 Participants
12 parent-child dyads participated in the biweekly arm which convened for 6 sessions.
|
Monthly Arm
n=8 Participants
8 parent-child dyads participated in the monthly arm which convened for 6 sessions.
|
Weekly Arm
n=6 Participants
6 parent-child dyads participated in the weekly arm which convened for 6 sessions.
|
|---|---|---|---|
|
Attendance
Number of Participants in Attendance at Session 1
|
11 Participants
|
8 Participants
|
2 Participants
|
|
Attendance
Number of Participants in Attendance at Session 2
|
12 Participants
|
8 Participants
|
2 Participants
|
|
Attendance
Number of Participants in Attendance at Session 3
|
8 Participants
|
7 Participants
|
3 Participants
|
|
Attendance
Number of Participants in Attendance at Session 4
|
10 Participants
|
4 Participants
|
6 Participants
|
|
Attendance
Number of Participants in Attendance at Session 5
|
11 Participants
|
6 Participants
|
4 Participants
|
|
Attendance
Number of Participants in Attendance at Session 6
|
8 Participants
|
5 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsParticipants evaluated their satisfaction with the group sessions using a 5 point scale with a score of 1 being complete dissatisfaction and 5 being the greatest satisfaction.
Outcome measures
| Measure |
Biweekly Arm
n=12 Participants
12 parent-child dyads participated in the biweekly arm which convened for 6 sessions.
|
Monthly Arm
n=8 Participants
8 parent-child dyads participated in the monthly arm which convened for 6 sessions.
|
Weekly Arm
n=6 Participants
6 parent-child dyads participated in the weekly arm which convened for 6 sessions.
|
|---|---|---|---|
|
Overall Satisfaction With Group Nutrition Sessions
|
4.82 score on a scale
Interval 4.0 to 5.0
|
4.68 score on a scale
Interval 4.0 to 5.0
|
4.79 score on a scale
Interval 4.0 to 5.0
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsPopulation: Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases. Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.
Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases. Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: PEDS QL was only administered to the Biweekly Arm.
Measure Description: PedsQL (Pediatric Quality of Life Inventory) is a modular instrument for measuring health-related quality of life in children and adolescents ages 2 to 18. Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better Health-Related Quality of Life.
Outcome measures
| Measure |
Biweekly Arm
n=12 Participants
12 parent-child dyads participated in the biweekly arm which convened for 6 sessions.
|
Monthly Arm
8 parent-child dyads participated in the monthly arm which convened for 6 sessions.
|
Weekly Arm
6 parent-child dyads participated in the weekly arm which convened for 6 sessions.
|
|---|---|---|---|
|
PedsQL (Pediatric Quality of Life Inventory)
Baseline
|
72 score on a scale
Interval 53.0 to 85.0
|
—
|
—
|
|
PedsQL (Pediatric Quality of Life Inventory)
3 months
|
74 score on a scale
Interval 68.0 to 91.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Due to recruitment and retention issues, BMI Z-score was not evaluated for the weekly arm.
BMI Z-scores compares child to age and sex matched peers. A z-score of 0 is the same as a 50th percentile in the reference population, a z-score of ± 1.0 plots at the 15th or 85th percentiles, respectively, and a z-score of ± 2 plots at roughly the 3rd or 97th percentiles. Negative numbers indicate values lower than the reference population whereas positive numbers indicate values higher than the reference population.
Outcome measures
| Measure |
Biweekly Arm
n=12 Participants
12 parent-child dyads participated in the biweekly arm which convened for 6 sessions.
|
Monthly Arm
n=8 Participants
8 parent-child dyads participated in the monthly arm which convened for 6 sessions.
|
Weekly Arm
6 parent-child dyads participated in the weekly arm which convened for 6 sessions.
|
|---|---|---|---|
|
BMI Z-Score
|
1.84 score
Standard Deviation 0.43
|
2.15 score
Standard Deviation 0.41
|
—
|
SECONDARY outcome
Timeframe: baseline, 3 monthsPopulation: The results for overall satisfaction are listed under outcome #2 under primary outcomes.
The description of the overall satisfaction variable is described in outcome #2 under primary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: This measure was administered at 3 months in biweekly arm and monthly arm, but not administered in weekly arm. All completed subjects contributed data in biweekly arm; 7 subjects contributed data for monthly arm.
Self efficacy was assessed using a validated 14-item questionnaire using a 5-point Strongly Agree/ Strongly Disagree scale. The range of values is 1 to 5, with lower values indicating higher self-efficacy
Outcome measures
| Measure |
Biweekly Arm
n=12 Participants
12 parent-child dyads participated in the biweekly arm which convened for 6 sessions.
|
Monthly Arm
n=7 Participants
8 parent-child dyads participated in the monthly arm which convened for 6 sessions.
|
Weekly Arm
6 parent-child dyads participated in the weekly arm which convened for 6 sessions.
|
|---|---|---|---|
|
Child Self-efficacy Related to Physical Activity
Baseline
|
1.71 score on a scale
Interval 1.26 to 2.39
|
2.07 score on a scale
Interval 1.86 to 2.07
|
—
|
|
Child Self-efficacy Related to Physical Activity
3 months
|
1.71 score on a scale
Interval 1.18 to 2.0
|
1.43 score on a scale
Interval 1.29 to 2.14
|
—
|
SECONDARY outcome
Timeframe: baseline, 3 monthsPopulation: This measure was administered at 3 months in biweekly arm and monthly arm, but not administered in weekly arm. All completed subjects contributed data in biweekly arm; 7 subjects contributed data for monthly arm.
Child intention to be active was assessed with a 1-item questionnaire developed and validated by Saunders et al. This item uses a 5-point scale, with possible range of scores being 1 to 5. Higher scores indicate greater intention to be active.
Outcome measures
| Measure |
Biweekly Arm
n=12 Participants
12 parent-child dyads participated in the biweekly arm which convened for 6 sessions.
|
Monthly Arm
n=7 Participants
8 parent-child dyads participated in the monthly arm which convened for 6 sessions.
|
Weekly Arm
6 parent-child dyads participated in the weekly arm which convened for 6 sessions.
|
|---|---|---|---|
|
Child Intention to be Active
Baseline
|
4.00 score on a scale
Interval 3.0 to 5.0
|
4.00 score on a scale
Interval 3.0 to 5.0
|
—
|
|
Child Intention to be Active
3 months
|
4.00 score on a scale
Interval 4.0 to 5.0
|
4.50 score on a scale
Interval 4.0 to 5.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases. Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.
Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases. Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.
Outcome measures
Outcome data not reported
Adverse Events
Biweekly Arm
Monthly Arm
Weekly Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr.Kristen Copeland
Cincinnati Children's Hospital Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place