STEP IN: Supporting Together Exercise and Play and Improving Nutrition

• Sponsor: Children's Hospital Medical Center, Cincinnati (Other)
• Overall Status: Completed
• CT.gov ID: NCT02724839
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 3
• Actual Duration (Months): 42
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The purpose of this study is to design, pilot, and tweak a series of peer-led group nutrition sessions for primary care patients aged 6 -12 years who are overweight or obese and who want to eat healthier and be more active.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Group nutrition sessions; Device: Fitbit	N/A

Detailed Description

In addition to the group nutrition sessions, the investigators will give a Fitbit to each of a parent and child dyad, which will be used to track and motivate their activity. The investigators hypothesize an improvement pre-post in children's physical activity levels, self-efficacy and intentions for physical activity, self-reported consumption of fruits, vegetables, and child quality of life, and a decrease in consumption of sugar-sweetened beverages and fast and snack-food, and television (TV)/ videos screen time

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Innovations in the Management of Obesity and Inactivity in Pediatric Primary Care
• Actual Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Oct 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Biweekly Arm 6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session. Sessions took place biweekly.	Behavioral: Group nutrition sessions; The intervention will consist of 6 nutrition group sessions co-led by parent and a professional from the community who will rotate at each session. Group nutrition sessions will consist 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. Three non-concurrent phases of the study will compare the efficacy of the group sessions when offered biweekly (Arm 1), monthly (Arm 2) and weekly (Arm 3).; Other Names: Peer-led Group Sessions ; Device: Fitbit; Parent and child dyads will each receive a Fitbit Flex wearable device at the second session. This device will be used by participants and investigators to motivate and track participants' physical activity for up to 9 months.
Experimental: Monthly Arm 6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session. Sessions took place monthly.	Behavioral: Group nutrition sessions; The intervention will consist of 6 nutrition group sessions co-led by parent and a professional from the community who will rotate at each session. Group nutrition sessions will consist 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. Three non-concurrent phases of the study will compare the efficacy of the group sessions when offered biweekly (Arm 1), monthly (Arm 2) and weekly (Arm 3).; Other Names: Peer-led Group Sessions ; Device: Fitbit; Parent and child dyads will each receive a Fitbit Flex wearable device at the second session. This device will be used by participants and investigators to motivate and track participants' physical activity for up to 9 months.
Experimental: Weekly 6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session. Sessions took place weekly.	Behavioral: Group nutrition sessions; The intervention will consist of 6 nutrition group sessions co-led by parent and a professional from the community who will rotate at each session. Group nutrition sessions will consist 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. Three non-concurrent phases of the study will compare the efficacy of the group sessions when offered biweekly (Arm 1), monthly (Arm 2) and weekly (Arm 3).; Other Names: Peer-led Group Sessions ; Device: Fitbit; Parent and child dyads will each receive a Fitbit Flex wearable device at the second session. This device will be used by participants and investigators to motivate and track participants' physical activity for up to 9 months.

Outcome Measures

Primary Outcome Measures

1. Attendance [Baseline, 3 months]

   Evaluation of participant attendance in each arm.

2. Overall Satisfaction With Group Nutrition Sessions [Baseline, 3 months]

   Participants 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.

3. Change From Baseline in Parent-report Child's Daily Servings of Fruits and Vegetables and Time Spent on Screens. [Baseline, 3 months]

   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.

Secondary Outcome Measures

1. PedsQL (Pediatric Quality of Life Inventory) [Baseline, 3 months]

   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.

2. BMI Z-Score [Baseline, 3 months]

   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.

3. Number of Participants Reporting They Were Satisfied With the Group Nutrition Sessions (4 or 5 on 5-point Likert Scale) [baseline, 3 months]

   The description of the overall satisfaction variable is described in outcome #2 under primary outcomes.

4. Child Self-efficacy Related to Physical Activity [Baseline, 3 months]

   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

5. Child Intention to be Active [baseline, 3 months]

   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.

6. Change From Baseline in Parent-reported Number of Hours of Screen Time Child Watches Daily [Baseline, 3 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients whose primary medical home is the Pediatric Primary Care Center (primarily Medicaid or self-pay)

• BMI is greater than 85th%ile for age and sex

• English speaking

• have access to a computer/internet or a smart phone (for uploading Fitbit data)

Exclusion Criteria:

• Have been seen in a weight management clinic within the last 2 years

• prescribed an atypical antipsychotic

• non-ambulatory

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pediatric Primary Care Center (PPC) Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

• Children's Hospital Medical Center, Cincinnati

Investigators

• Principal Investigator: Kristen A Copeland, Children's Hospital Medical Center, Cincinnati

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 17, 2018
• Informed Consent Form - Feb 20, 2018

More Information

Publications

• Saunders RP, Pate RR, Felton G, Dowda M, Weinrich MC, Ward DS, Parsons MA, Baranowski T. Development of questionnaires to measure psychosocial influences on children's physical activity. Prev Med. 1997 Mar-Apr;26(2):241-7.

• Responsible Party: Children's Hospital Medical Center, Cincinnati
• ClinicalTrials.gov Identifier: NCT02724839
• Other Study ID Numbers: 2015-3406
• First Posted: Mar 31, 2016
• Last Update Posted: Nov 27, 2020
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Biweekly Arm	Monthly Arm	Weekly Arm
Arm/Group Description	13 parent-child dyads were enrolled in this arm which convened biweekly.	12 parent-child dyads were enrolled in this arm which convened monthly.	8 parent-child dyads were enrolled in this arm which convened weekly.
Period Title: Overall Study
STARTED	13	12	11
COMPLETED	12	8	6
NOT COMPLETED	1	4	5

Baseline Characteristics

Arm/Group Title	Biweekly Arm	Monthly Arm	Weekly Arm	Total
Arm/Group Description	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.	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.	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 of all reporting groups
Overall Participants	12	8	6	26
Age (Count of Participants)
<=18 years	12 100%	8 100%	6 100%	26 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	10 (2)	8 (2)	11 (2)	10 (2)
Sex: Female, Male (Count of Participants)
Female	12 100%	6 75%	6 100%	24 92.3%
Male	0 0%	2 25%	0 0%	2 7.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	1 12.5%	0 0%	1 3.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	10 83.3%	6 75%	3 50%	19 73.1%
White	1 8.3%	1 12.5%	3 50%	5 19.2%
More than one race	1 8.3%	0 0%	0 0%	1 3.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	12 100%	8 100%	6 100%	26 100%

Outcome Measures

1. Primary Outcome

Title	Attendance
Description	Evaluation of participant attendance in each arm.
Time Frame	Baseline, 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Biweekly Arm	Monthly Arm	Weekly Arm
Arm/Group Description	12 parent-child dyads participated in the biweekly arm which convened for 6 sessions.	8 parent-child dyads participated in the monthly arm which convened for 6 sessions.	6 parent-child dyads participated in the weekly arm which convened for 6 sessions.
Measure Participants	12	8	6
Number of Participants in Attendance at Session 1	11 91.7%	8 100%	2 33.3%
Number of Participants in Attendance at Session 2	12 100%	8 100%	2 33.3%
Number of Participants in Attendance at Session 3	8 66.7%	7 87.5%	3 50%
Number of Participants in Attendance at Session 4	10 83.3%	4 50%	6 100%
Number of Participants in Attendance at Session 5	11 91.7%	6 75%	4 66.7%
Number of Participants in Attendance at Session 6	8 66.7%	5 62.5%	6 100%

2. Primary Outcome

Title	Overall Satisfaction With Group Nutrition Sessions
Description	Participants 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.
Time Frame	Baseline, 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Biweekly Arm	Monthly Arm	Weekly Arm
Arm/Group Description	12 parent-child dyads participated in this arm which convened for 6 sessions.	8 parent-child dyads participated in this arm which convened for 6 sessions.	6 parent-child dyads participated in this arm which convened for 6 sessions.
Measure Participants	12	8	6
Mean (Full Range) [score on a scale]	4.82	4.68	4.79

3. Primary Outcome

Title	Change From Baseline in Parent-report Child's Daily Servings of Fruits and Vegetables and Time Spent on Screens.
Description	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.
Time Frame	Baseline, 3 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Biweekly Arm	Monthly Arm	Weekly Arm
Arm/Group Description	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.	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.	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.
Measure Participants	0	0	0

4. Secondary Outcome

Title	PedsQL (Pediatric Quality of Life Inventory)
Description	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.
Time Frame	Baseline, 3 months

Outcome Measure Data

Analysis Population Description

PEDS QL was only administered to the Biweekly Arm.

Arm/Group Title	Biweekly Arm	Monthly Arm	Weekly Arm
Arm/Group Description	12 parent-child dyads participated in the biweekly arm which convened for 6 sessions.	8 parent-child dyads participated in the monthly arm which convened for 6 sessions.	6 parent-child dyads participated in the weekly arm which convened for 6 sessions.
Measure Participants	12	0	0
Baseline	72
3 months	74

5. Secondary Outcome

Title	BMI Z-Score
Description	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.
Time Frame	Baseline, 3 months

Outcome Measure Data

Analysis Population Description

Due to recruitment and retention issues, BMI Z-score was not evaluated for the weekly arm.

Arm/Group Title	Biweekly Arm	Monthly Arm	Weekly Arm
Arm/Group Description	12 parent-child dyads participated in the biweekly arm which convened for 6 sessions.	8 parent-child dyads participated in the monthly arm which convened for 6 sessions.	Due to recruitment and retention issues, BMI Z-score was not evaluated for the weekly arm.
Measure Participants	12	8	0
Mean (Standard Deviation) [score]	1.84 (0.43)	2.15 (0.41)

6. Secondary Outcome

Title	Number of Participants Reporting They Were Satisfied With the Group Nutrition Sessions (4 or 5 on 5-point Likert Scale)
Description	The description of the overall satisfaction variable is described in outcome #2 under primary outcomes.
Time Frame	baseline, 3 months

Outcome Measure Data

Analysis Population Description

The results for overall satisfaction are listed under outcome #2 under primary outcomes.

Arm/Group Title	Biweekly Arm	Monthly Arm	Weekly Arm
Arm/Group Description	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.	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.	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.
Measure Participants	0	0	0

7. Secondary Outcome

Title	Child Self-efficacy Related to Physical Activity
Description	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
Time Frame	Baseline, 3 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Biweekly Arm	Monthly Arm	Weekly Arm
Arm/Group Description	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.	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.	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.
Measure Participants	12	7	0
Baseline	1.71	2.07
3 months	1.71	1.43

8. Secondary Outcome

Title	Child Intention to be Active
Description	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.
Time Frame	baseline, 3 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Biweekly Arm	Monthly Arm	Weekly Arm
Arm/Group Description	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.	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.	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.
Measure Participants	12	7	0
Baseline	4.00	4.00
3 months	4.00	4.50

9. Secondary Outcome

Title	Change From Baseline in Parent-reported Number of Hours of Screen Time Child Watches Daily
Description	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.
Time Frame	Baseline, 3 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Biweekly Arm	Monthly Arm	Weekly Arm
Arm/Group Description	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.	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.	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.
Measure Participants	0	0	0

Adverse Events

Time Frame	12 months
Arm/Group Title	Biweekly Arm		Monthly Arm		Weekly Arm
Arm/Group Description	12 parent-child dyads participated in the biweekly arm which convened for 6 sessions.		8 parent-child dyads participated in the biweekly arm which convened for 6 sessions.		6 parent-child dyads participated in the biweekly arm which convened for 6 sessions.
All Cause Mortality
	Biweekly Arm		Monthly Arm		Weekly Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/8 (0%)		0/6 (0%)
Serious Adverse Events
	Biweekly Arm		Monthly Arm		Weekly Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/8 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Biweekly Arm		Monthly Arm		Weekly Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/8 (0%)		0/6 (0%)

Limitations/Caveats

Small number of subjects analyzed. Difficulty recruiting and retaining engaged participants for collection of all desired outcome measures.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.