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Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02124460
Recruitment Status : Completed
First Posted : April 28, 2014
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Collaborators:
Harvard Vanguard Medical Associates
Brigham and Women's Hospital
Information provided by (Responsible Party):
Elsie Taveras, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Overweight
Obesity
Intervention Behavioral: Health Coaching
Enrollment 721
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Enhanced Primary Care Health Coaching
Hide 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
Arm/Group Title Enhanced Primary Care Health Coaching Total
Hide 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 Number of Baseline Participants 361 360 721
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 361 participants 360 participants 721 participants
<=18 years
361
 100.0%
360
 100.0%
721
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 361 participants 360 participants 721 participants
8.0  (3.0) 8.1  (3.0) 8.0  (3.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 361 participants 360 participants 721 participants
Female
188
  52.1%
180
  50.0%
368
  51.0%
Male
173
  47.9%
180
  50.0%
353
  49.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 361 participants 360 participants 721 participants
361 360 721
BMI z score  
Mean (Standard Deviation)
Unit of measure:  BMI z score units
Number Analyzed 361 participants 360 participants 721 participants
1.90  (0.51) 1.86  (0.52) 1.88  (0.52)
Pediatric Quality of Life (PedsQL) Summary Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 361 participants 360 participants 721 participants
86.0  (10.8) 85.4  (11.4) 85.7  (11.1)
[1]
Measure Description: 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.
Parent Resource Empowerment   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 361 participants 360 participants 721 participants
2.93  (0.59) 2.96  (0.53) 2.95  (0.56)
[1]
Measure 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. Responses ranged from Strongly disagree to Strongly agree (range = 1-4). 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.
1.Primary Outcome
Title Change in BMI z Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enhanced Primary Care Health Coaching
Hide 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.
Overall Number of Participants Analyzed 361 360
Mean (95% Confidence Interval)
Unit of Measure: BMI z score units
-0.06
(-0.10 to -0.02)
-0.09
(-0.13 to -0.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enhanced Primary Care, Health Coaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3928
Comments [Not Specified]
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
Estimation Comments Health Coaching group compared to Enhanced Primary Care
2.Primary Outcome
Title Change in Quality of Life
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enhanced Primary Care Health Coaching
Hide 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.
Overall Number of Participants Analyzed 361 360
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.65
(-0.38 to 1.67)
1.53
(0.51 to 2.56)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enhanced Primary Care, Health Coaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2306
Comments [Not Specified]
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
Estimation Comments Health Coaching group compared to Enhanced Primary Care
3.Primary Outcome
Title Change in Parent Resource Empowerment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enhanced Primary Care Health Coaching
Hide 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.
Overall Number of Participants Analyzed 361 360
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.29
(0.22 to 0.35)
0.22
(0.15 to 0.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enhanced Primary Care, Health Coaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .14
Comments [Not Specified]
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
Estimation Comments Health Coaching group compared to Enhanced Primary Care.
4.Secondary Outcome
Title Change in Screen Time
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enhanced Primary Care Health Coaching
Hide 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.
Overall Number of Participants Analyzed 361 360
Mean (95% Confidence Interval)
Unit of Measure: hours/day
-0.06
(-0.12 to 0.00)
-0.56
(-0.78 to -0.34)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enhanced Primary Care, Health Coaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0016
Comments [Not Specified]
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
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Sleep
Hide Description Average hours/day spent sleeping
Time Frame baseline and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enhanced Primary Care Health Coaching
Hide 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.
Overall Number of Participants Analyzed 361 360
Mean (95% Confidence Interval)
Unit of Measure: hours/day
-0.02
(-0.16 to 0.12)
0.40
(0.25 to 0.55)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enhanced Primary Care, Health Coaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Multiple imputation used for missing data at follow-up.
Method Linear repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
0.22 to 0.62
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Physical Activity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enhanced Primary Care Health Coaching
Hide 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.
Overall Number of Participants Analyzed 361 360
Mean (95% Confidence Interval)
Unit of Measure: days/week
0.15
(-0.10 to 0.40)
0.33
(0.09 to 0.58)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enhanced Primary Care, Health Coaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3043
Comments [Not Specified]
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
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in Fruit and Vegetable Consumption
Hide Description Number of times the child consumed of vegetables and fruits yesterday
Time Frame baseline and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enhanced Primary Care Health Coaching
Hide 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.
Overall Number of Participants Analyzed 361 360
Mean (95% Confidence Interval)
Unit of Measure: times/day
0.19
(0.01 to 0.36)
0.50
(0.33 to 0.68)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enhanced Primary Care, Health Coaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0113
Comments [Not Specified]
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
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change in Consumption of Sugar-sweetened Beverages and Juice
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enhanced Primary Care Health Coaching
Hide 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.
Overall Number of Participants Analyzed 361 360
Mean (95% Confidence Interval)
Unit of Measure: times/day
-0.03
(-0.20 to 0.14)
-0.25
(-0.41 to -0.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enhanced Primary Care, Health Coaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0792
Comments [Not Specified]
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
Estimation Comments [Not Specified]
9.Post-Hoc Outcome
Title Increased Satisfaction With Care at Harvard Vanguard Medical Associates (HVMA)
Hide Description This is a feasibility and acceptability measure from the study.
Time Frame 1 year
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 321 315
Measure Type: Count of Participants
Unit of Measure: Participants
153
  47.7%
199
  63.2%
10.Post-Hoc Outcome
Title Parent Very Satisfied With Content of Connect 4 Health Text Messages or Emails.
Hide Description This is a feasibility and acceptability measure from the study.
Time Frame 1 year
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 292 313
Measure Type: Count of Participants
Unit of Measure: Participants
156
  53.4%
226
  72.2%
11.Post-Hoc Outcome
Title Received Information From Connect 4 Health About Resources in the Community
Hide Description This is a feasibility and acceptability measure from the study.
Time Frame 1 year
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 323 315
Measure Type: Count of Participants
Unit of Measure: Participants
195
  60.4%
301
  95.6%
12.Post-Hoc Outcome
Title Received Text Messages or Emails From Connect 4 Health
Hide Description This is a feasibility and acceptability measure from the study.
Time Frame 1 year
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 323 315
Measure Type: Count of Participants
Unit of Measure: Participants
295
  91.3%
314
  99.7%
13.Post-Hoc Outcome
Title Parent Very Satisfied With Information he/She Received About Resources in the Community
Hide Description This is a feasibility and acceptability measure from the study.
Time Frame 1 year
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 195 301
Measure Type: Count of Participants
Unit of Measure: Participants
128
  65.6%
228
  75.7%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enhanced Primary Care Health Coaching
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Enhanced Primary Care Health Coaching
Affected / at Risk (%) Affected / at Risk (%)
Total   0/361 (0.00%)   0/360 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Enhanced Primary Care Health Coaching
Affected / at Risk (%) Affected / at Risk (%)
Total   0/361 (0.00%)   0/360 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Elsie Taveras
Organization: Massachusetts General Hospital
Phone: 617-726-8555
EMail: elsie.taveras@mgh.harard.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Elsie Taveras, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02124460    
Other Study ID Numbers: IH-1304-6739
First Submitted: April 14, 2014
First Posted: April 28, 2014
Results First Submitted: October 28, 2016
Results First Posted: April 10, 2017
Last Update Posted: April 10, 2017