Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02124460
• Collaborator: Harvard Vanguard Medical Associates (Other), Brigham and Women's Hospital (Other)
• Enrollment: 721
• Location: 1
• Arms: 2
• Duration (Months): 29
• Patients Per Site Per Month: 24.8

Study Details

Study Description

Brief Summary

Health care system (HCS)-based interventions have been limited by their inattention to social and environmental barriers that impede improvement in obesity-related behaviors. Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity. HCSs often lack the organizational structure to provide longitudinal care for children with chronic illnesses, the clinicians to manage and support patients with chronic illnesses outside of clinic, and/or the health information systems that support the use of evidence-based practices at the point-of-care. Thus, the research question this study is designed to address is whether a novel approach to care delivery that leverages delivery system and community resources and addresses socio-contextual factors will improve family-centered childhood obesity outcomes.

The primary specific aims are to examine the extent to which the intervention, compared to the control condition, results in:

1. A smaller age-associated increase in BMI over a 12-month period.

2. Improved parental and child ratings of pediatric health-related quality of life.

The secondary aims are:

1. To examine parental ratings of quality and family-centeredness of pediatric obesity care and compare outcomes among participants in the intervention with the control condition

2. To assess change in weight-related behaviors and compare outcomes among participants in the intervention with the control condition

3. To assess the following process measures:

• Reach

• Extent of implementation

• Fidelity to protocol

• Parent satisfaction

1. To examine the extent to which neighborhood environments modify observed intervention effects

2. To assess the documentation of Healthcare Effectiveness Data and Information Set (HEDIS) measures in participant medical records

Condition or Disease	Intervention/Treatment	Phase
Overweight; Obesity	Behavioral: Health Coaching	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 721 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improving Childhood Obesity Outcomes: Testing Best Practices of Positive Outliers
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Enhanced Primary Care We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.
Experimental: Health Coaching The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.	Behavioral: Health Coaching; Parent/child duos enrolled in the intervention group will participate in a total of six visits with a trained health coach. During these visits, the health coach will coach the parent/child duos on improving obesity-related behaviors . The health coach will also help the family identify supports to assist with behavior change; discuss family health habits and the home environment; and review and encourage use of materials related to both specific target behaviors and available resources in the community. Following the first call with the health coach, parents will receive semi-weekly text messages designed by the study team. The messages will alternate in structure between 2 types of messages; 1) skills training messages will deliver tips and motivational messages to help their child practice the study's goals and 2) self monitoring messages will ask parents to respond to the message and track health behaviors important to this study.

Outcome Measures

Primary Outcome Measures

1. Change in BMI z Score [baseline and one year]

   Height and weight will be measured by the medical assistants at each site using standard protocols. BMI measures will be obtained from the electronic health record (EHR) as provided through usual care. BMI measures will be converted to z-scores using CDC age and sex-specific normative data for children between 2 and 20 years old. This will allow the research team to combine data across children of different ages.

2. Change in Quality of Life [baseline and one year]

   The PedsQL is an extensively validated, widely used, 23-item measure of health-related quality of life in children with chronic conditions such as obesity. Parents will be asked to complete 4 subscales: physical health, school, social, and emotional functioning which exists for parental report of children as young as 2 years of age. Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better HRQOL. Scale Scores are computed as the sum of the items divided by the number of items answered (this accounts for missing data). If more than 50% of the items in the scale are missing, the Scale Score is not computed.

3. Change in Parent Resource Empowerment [Baseline to one-year follow-up]

   The five items in the scale assessed parents' perceived knowledge of resources, ability to access resources, comfort with accessing resources, knowledge of how to find resources, and ability to acquire resources related to child weight management. For each question, parents responded strongly disagree, disagree, agree, or strongly agree, which were worth 1 to 4 points, respectively. Items were averaged to create a summary parental resource empowerment score (range= 1-4), where a higher score indicated greater perceived knowledge and ability to access resources related to weight management. Cronbach's α for this score was 0.87.

Secondary Outcome Measures

1. Change in Screen Time [baseline and one year]

   Average hours/day spent watching television, videos, or playing games displayed on media such as television, desktop computers, laptops, portable DVD players, iPads or smartphones.

2. Change in Sleep [baseline and 1 year]

   Average hours/day spent sleeping

3. Change in Physical Activity [baseline and 1 year]

   In the past week, how many days the child was physically active for a total of at least 60 minutes per day.

4. Change in Fruit and Vegetable Consumption [baseline and 1 year]

   Number of times the child consumed of vegetables and fruits yesterday

5. Change in Consumption of Sugar-sweetened Beverages and Juice [baseline and 1 year]

   Number of time child consumed juice (e.g., orange juice, apple juice, or grape juice), fruit-flavored drinks (e.g., Kool-Aid, sports drinks, Goya juice, etc.), regular soda, soft drinks, or Malta yesterday.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• child is age 2.0 through 12.9 years at baseline primary care visit,

• child's BMI is equal to or exceeds the 85th percentile for age and sex at baseline primary care visit,

• at least 1 parent has an active email address,

• at least one parent is comfortable reading and speaking in English.

Exclusion Criteria:

• children who do not have at least one parent/legal guardian who is able to follow study procedures for 1 year,

• families who plan to leave HVMA within the study time frame,

• families for whom the primary care clinician thinks the intervention is inappropriate, e.g., emotional or cognitive difficulties,

• children who have a sibling already enrolled in the study,

• children with chronic conditions that substantially interfere with growth or physical activity participation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harvard Vanguard Medical Associates	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Massachusetts General Hospital
• Harvard Vanguard Medical Associates
• Brigham and Women's Hospital

Investigators

• Principal Investigator: Elsie M Taveras, MD, MPH, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elsie Taveras, MD, Chief, Division of General Academic Pediatrics, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02124460
• Other Study ID Numbers: IH-1304-6739
• First Posted: Apr 28, 2014
• Last Update Posted: Apr 10, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Elsie Taveras, MD, Chief, Division of General Academic Pediatrics, Massachusetts General Hospital: Pediatric; Obesity; Overweight; Intervention
• Additional relevant MeSH terms: Obesity; Pediatric Obesity; Overweight

Study Results

Participant Flow

Arm/Group Title	Enhanced Primary Care	Health Coaching
Arm/Group Description	We will provide current "best practice" to the enhanced primary care arm. We will encourage providers use clinical decision support tools and to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.	The intervention group will receive the same components as the enhanced primary care group for this study plus the following elements: visits with a health coach, individualized connection to community resources and an interactive text messaging program. Parent/child duos enrolled in the intervention group will participate in a total of six visits with a trained health coach. The health coach will coach the parent/child duos on improving obesity-related behaviors and help the family identify supports to assist with behavior change and encourage use of materials related to both specific target behaviors and available resources in the community. Parents will receive semi-weekly text messages. The messages will alternate in structure between 1) skills training messages will deliver tips to help their child practice the study's goals and 2) self monitoring messages will ask parents to respond and track health behaviors important to this study.
Period Title: Overall Study
STARTED	361	360
COMPLETED	328	336
NOT COMPLETED	33	24

Baseline Characteristics

Arm/Group Title	Enhanced Primary Care	Health Coaching	Total
Arm/Group Description	Arm: No Intervention: Enhanced Primary Care We will provide current "best practice" to the control arm. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.	Arm: Experimental: Health Coaching The intervention for this study will consist of three elements: visits with a health coach, connection to community resources and an interactive text messaging program.	Total of all reporting groups
Overall Participants	361	360	721
Age (Count of Participants)
<=18 years	361 100%	360 100%	721 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	8.0 (3.0)	8.1 (3.0)	8.0 (3.0)
Sex: Female, Male (Count of Participants)
Female	188 52.1%	180 50%	368 51%
Male	173 47.9%	180 50%	353 49%
Region of Enrollment (participants) [Number]
United States	361 100%	360 100%	721 100%
BMI z score (BMI z score units) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [BMI z score units]	1.90 (0.51)	1.86 (0.52)	1.88 (0.52)
Pediatric Quality of Life (PedsQL) Summary Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	86.0 (10.8)	85.4 (11.4)	85.7 (11.1)
Parent Resource Empowerment (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.93 (0.59)	2.96 (0.53)	2.95 (0.56)

Outcome Measures

1. Primary Outcome

Title	Change in BMI z Score
Description	Height and weight will be measured by the medical assistants at each site using standard protocols. BMI measures will be obtained from the electronic health record (EHR) as provided through usual care. BMI measures will be converted to z-scores using CDC age and sex-specific normative data for children between 2 and 20 years old. This will allow the research team to combine data across children of different ages.
Time Frame	baseline and one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enhanced Primary Care	Health Coaching
Arm/Group Description	We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged by in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.	The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
Measure Participants	361	360
Mean (95% Confidence Interval) [BMI z score units]	-0.06	-0.09

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced Primary Care, Health Coaching
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3928
	Comments
	Method	Linear repeated measures
	Comments	Multiple imputation was used for missing follow-up data.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 95%; -0.08 to 0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments	Health Coaching group compared to Enhanced Primary Care

2. Primary Outcome

Title	Change in Quality of Life
Description	The PedsQL is an extensively validated, widely used, 23-item measure of health-related quality of life in children with chronic conditions such as obesity. Parents will be asked to complete 4 subscales: physical health, school, social, and emotional functioning which exists for parental report of children as young as 2 years of age. Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better HRQOL. Scale Scores are computed as the sum of the items divided by the number of items answered (this accounts for missing data). If more than 50% of the items in the scale are missing, the Scale Score is not computed.
Time Frame	baseline and one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enhanced Primary Care	Health Coaching
Arm/Group Description	We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged by in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.	The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
Measure Participants	361	360
Mean (95% Confidence Interval) [units on a scale]	0.65	1.53

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced Primary Care, Health Coaching
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2306
	Comments
	Method	Linear repeated measures
	Comments	Multiple imputation used for missing data at follow-up
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; -0.56 to 2.33
	Parameter Dispersion	Type: Value:
	Estimation Comments	Health Coaching group compared to Enhanced Primary Care

3. Primary Outcome

Title	Change in Parent Resource Empowerment
Description	The five items in the scale assessed parents' perceived knowledge of resources, ability to access resources, comfort with accessing resources, knowledge of how to find resources, and ability to acquire resources related to child weight management. For each question, parents responded strongly disagree, disagree, agree, or strongly agree, which were worth 1 to 4 points, respectively. Items were averaged to create a summary parental resource empowerment score (range= 1-4), where a higher score indicated greater perceived knowledge and ability to access resources related to weight management. Cronbach's α for this score was 0.87.
Time Frame	Baseline to one-year follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enhanced Primary Care	Health Coaching
Arm/Group Description	We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged by in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.	The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
Measure Participants	361	360
Mean (95% Confidence Interval) [units on a scale]	0.29	0.22

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced Primary Care, Health Coaching
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.14
	Comments
	Method	Linear repeated measures
	Comments	Multiple imputation used for missing data at follow-up
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.07
	Confidence Interval	(2-Sided) 95%; -0.02 to 0.16
	Parameter Dispersion	Type: Value:
	Estimation Comments	Health Coaching group compared to Enhanced Primary Care.

4. Secondary Outcome

Title	Change in Screen Time
Description	Average hours/day spent watching television, videos, or playing games displayed on media such as television, desktop computers, laptops, portable DVD players, iPads or smartphones.
Time Frame	baseline and one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enhanced Primary Care	Health Coaching
Arm/Group Description	We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged by in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.	The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
Measure Participants	361	360
Mean (95% Confidence Interval) [hours/day]	-0.06	-0.56

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced Primary Care, Health Coaching
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0016
	Comments
	Method	Linear repeated measures
	Comments	Multiple imputation used for missing data at follow-up.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.50
	Confidence Interval	(2-Sided) 95%; -0.81 to -0.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Change in Sleep
Description	Average hours/day spent sleeping
Time Frame	baseline and 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enhanced Primary Care	Health Coaching
Arm/Group Description	We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.	The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
Measure Participants	361	360
Mean (95% Confidence Interval) [hours/day]	-0.02	0.40

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced Primary Care, Health Coaching
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments	Multiple imputation used for missing data at follow-up.
	Method	Linear repeated measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.42
	Confidence Interval	(2-Sided) 95%; 0.22 to 0.62
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Change in Physical Activity
Description	In the past week, how many days the child was physically active for a total of at least 60 minutes per day.
Time Frame	baseline and 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enhanced Primary Care	Health Coaching
Arm/Group Description	We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.	The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
Measure Participants	361	360
Mean (95% Confidence Interval) [days/week]	0.15	0.33

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced Primary Care, Health Coaching
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3043
	Comments
	Method	Linear repeated measures
	Comments	Multiple imputation used for missing data at follow-up.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.18
	Confidence Interval	(2-Sided) 95%; -0.16 to 0.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Change in Fruit and Vegetable Consumption
Description	Number of times the child consumed of vegetables and fruits yesterday
Time Frame	baseline and 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enhanced Primary Care	Health Coaching
Arm/Group Description	We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.	The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
Measure Participants	361	360
Mean (95% Confidence Interval) [times/day]	0.19	0.50

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced Primary Care, Health Coaching
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0113
	Comments
	Method	Linear repeated measures
	Comments	Multiple imputation used for missing data at follow-up.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.32
	Confidence Interval	(2-Sided) 95%; 0.07 to 0.56
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Change in Consumption of Sugar-sweetened Beverages and Juice
Description	Number of time child consumed juice (e.g., orange juice, apple juice, or grape juice), fruit-flavored drinks (e.g., Kool-Aid, sports drinks, Goya juice, etc.), regular soda, soft drinks, or Malta yesterday.
Time Frame	baseline and 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enhanced Primary Care	Health Coaching
Arm/Group Description	We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.	The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
Measure Participants	361	360
Mean (95% Confidence Interval) [times/day]	-0.03	-0.25

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced Primary Care, Health Coaching
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0792
	Comments
	Method	Linear repeated measures
	Comments	Multiple imputation used for missing data at follow-up.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.21
	Confidence Interval	(2-Sided) 95%; -0.45 to 0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Post-Hoc Outcome

Title	Increased Satisfaction With Care at Harvard Vanguard Medical Associates (HVMA)
Description	This is a feasibility and acceptability measure from the study.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses.

Arm/Group Title	Enhanced Primary Care	Health Coaching
Arm/Group Description	We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.	The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
Measure Participants	321	315
Count of Participants [Participants]	153 42.4%	199 55.3%

10. Post-Hoc Outcome

Title	Parent Very Satisfied With Content of Connect 4 Health Text Messages or Emails.
Description	This is a feasibility and acceptability measure from the study.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses. Additionally, only those who responded Yes to the previous question asking if they received text messages were included in this analysis.

Arm/Group Title	Enhanced Primary Care	Health Coaching
Arm/Group Description	We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.	The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
Measure Participants	292	313
Count of Participants [Participants]	156 43.2%	226 62.8%

11. Post-Hoc Outcome

Title	Received Information From Connect 4 Health About Resources in the Community
Description	This is a feasibility and acceptability measure from the study.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses.

Arm/Group Title	Enhanced Primary Care	Health Coaching
Arm/Group Description	We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.	The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
Measure Participants	323	315
Count of Participants [Participants]	195 54%	301 83.6%

12. Post-Hoc Outcome

Title	Received Text Messages or Emails From Connect 4 Health
Description	This is a feasibility and acceptability measure from the study.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses.

Arm/Group Title	Enhanced Primary Care	Health Coaching
Arm/Group Description	We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.	The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
Measure Participants	323	315
Count of Participants [Participants]	295 81.7%	314 87.2%

13. Post-Hoc Outcome

Title	Parent Very Satisfied With Information he/She Received About Resources in the Community
Description	This is a feasibility and acceptability measure from the study.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses. Additionally, only those who responded Yes to the previous question asking if they received community resources were included in this analysis.

Arm/Group Title	Enhanced Primary Care	Health Coaching
Arm/Group Description	We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.	The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
Measure Participants	195	301
Count of Participants [Participants]	128 35.5%	228 63.3%

Adverse Events

Arm/Group Title	Enhanced Primary Care		Health Coaching
Arm/Group Description	We will provide current "best practice" to the enhanced primary care arm. We will encourage providers use clinical decision support tools and to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.		The intervention group will receive the same components as the enhanced primary care group for this study plus the following elements: visits with a health coach, individualized connection to community resources and an interactive text messaging program. Parent/child duos enrolled in the intervention group will participate in a total of six visits with a trained health coach. The health coach will coach the parent/child duos on improving obesity-related behaviors and help the family identify supports to assist with behavior change and encourage use of materials related to both specific target behaviors and available resources in the community. Parents will receive semi-weekly text messages. The messages will alternate in structure between 1) skills training messages will deliver tips to help their child practice the study's goals and 2) self monitoring messages will ask parents to respond and track health behaviors important to this study.
All Cause Mortality
	Enhanced Primary Care		Health Coaching
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Enhanced Primary Care		Health Coaching
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/361 (0%)		0/360 (0%)
Other (Not Including Serious) Adverse Events
	Enhanced Primary Care		Health Coaching
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/361 (0%)		0/360 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.