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| Name | Class |
|---|---|
| Harvard Vanguard Medical Associates | OTHER |
| Brigham and Women's Hospital | OTHER |
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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 Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity.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:
The secondary aims are:
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
To assess change in weight-related behaviors and compare outcomes among participants in the intervention with the control condition
To assess the following process measures:
To examine the extent to which neighborhood environments modify observed intervention effects
To assess the documentation of Healthcare Effectiveness Data and Information Set (HEDIS) measures in participant medical records
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Primary Care | No Intervention | 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. | |
| Health Coaching | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Coaching | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BMI z Score | 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. | baseline and one year |
| Change in Quality of Life | 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. | baseline and one year |
| Change in Parent Resource Empowerment | 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. | Baseline to one-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Screen Time | 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. | baseline and one year |
| Change in Sleep |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elsie M Taveras, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard Vanguard Medical Associates | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39218948 | Derived | Simione M, Ferreira P, Luo M, Hoover C, Perkins M, Fiechtner L, Taveras EM. Psychometrics of the modified family-centered care assessment short version for childhood obesity. Health Qual Life Outcomes. 2024 Sep 2;22(1):71. doi: 10.1186/s12955-024-02284-5. | |
| 38798356 | Derived | Simione M, Ferreira P, Luo M, Hoover C, Perkins M, Fiechtner L, Taveras EM. Psychometrics of the modified Family-Centered Care Assessment short version for childhood obesity. Res Sq [Preprint]. 2024 May 15:rs.3.rs-4365570. doi: 10.21203/rs.3.rs-4365570/v1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced Primary Care | 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. |
| FG001 | Health Coaching | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Primary Care | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in BMI z Score | 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. | Posted | Mean | 95% Confidence Interval | BMI z score units | baseline and one year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enhanced Primary Care | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elsie Taveras | Massachusetts General Hospital | 617-726-8555 | elsie.taveras@mgh.harard.edu |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
Average hours/day spent sleeping
| baseline and 1 year |
| Change in Physical Activity | In the past week, how many days the child was physically active for a total of at least 60 minutes per day. | baseline and 1 year |
| Change in Fruit and Vegetable Consumption | Number of times the child consumed of vegetables and fruits yesterday | baseline and 1 year |
| Change in Consumption of Sugar-sweetened Beverages and Juice | 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. | baseline and 1 year |
| 32527270 | Derived | Simione M, Sharifi M, Gerber MW, Marshall R, Avalon E, Fiechtner L, Horan C, Orav EJ, Skelton J, Taveras EM. Family-centeredness of childhood obesity interventions: psychometrics & outcomes of the family-centered care assessment tool. Health Qual Life Outcomes. 2020 Jun 11;18(1):179. doi: 10.1186/s12955-020-01431-y. |
| 30925139 | Derived | Baskind MJ, Taveras EM, Gerber MW, Fiechtner L, Horan C, Sharifi M. Parent-Perceived Stress and Its Association With Children's Weight and Obesity-Related Behaviors. Prev Chronic Dis. 2019 Mar 28;16:E39. doi: 10.5888/pcd16.180368. |
| 30894004 | Derived | Bala N, Price SN, Horan CM, Gerber MW, Taveras EM. Use of Telehealth to Enhance Care in a Family-Centered Childhood Obesity Intervention. Clin Pediatr (Phila). 2019 Jun;58(7):789-797. doi: 10.1177/0009922819837371. Epub 2019 Mar 20. |
| 28682745 | Derived | Fiechtner L, Puente GC, Sharifi M, Block JP, Price S, Marshall R, Blossom J, Gerber MW, Taveras EM. A Community Resource Map to Support Clinical-Community Linkages in a Randomized Controlled Trial of Childhood Obesity, Eastern Massachusetts, 2014-2016. Prev Chronic Dis. 2017 Jul 6;14:E53. doi: 10.5888/pcd14.160577. |
| 28586856 | Derived | Taveras EM, Marshall R, Sharifi M, Avalon E, Fiechtner L, Horan C, Gerber MW, Orav EJ, Price SN, Sequist T, Slater D. Comparative Effectiveness of Clinical-Community Childhood Obesity Interventions: A Randomized Clinical Trial. JAMA Pediatr. 2017 Aug 7;171(8):e171325. doi: 10.1001/jamapediatrics.2017.1325. Epub 2017 Aug 7. |
| 26427562 | Derived | Taveras EM, Marshall R, Sharifi M, Avalon E, Fiechtner L, Horan C, Orav J, Price SN, Sequist T, Slater D. Connect for Health: Design of a clinical-community childhood obesity intervention testing best practices of positive outliers. Contemp Clin Trials. 2015 Nov;45(Pt B):287-295. doi: 10.1016/j.cct.2015.09.022. Epub 2015 Sep 30. |
| BG001 | Health Coaching | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI z score | Mean | Standard Deviation | BMI z score units |
|
| Pediatric Quality of Life (PedsQL) Summary Score | 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. | Mean | Standard Deviation | units on a scale |
|
| Parent Resource Empowerment | 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
|
| Primary | Change in Quality of Life | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | baseline and one year |
|
|
|
|
| Primary | Change in Parent Resource Empowerment | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to one-year follow-up |
|
|
|
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| Secondary | Change in Screen Time | 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. | Posted | Mean | 95% Confidence Interval | hours/day | baseline and one year |
|
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|
|
| Secondary | Change in Sleep | Average hours/day spent sleeping | Posted | Mean | 95% Confidence Interval | hours/day | baseline and 1 year |
|
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| Secondary | Change in Physical Activity | In the past week, how many days the child was physically active for a total of at least 60 minutes per day. | Posted | Mean | 95% Confidence Interval | days/week | baseline and 1 year |
|
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|
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| Secondary | Change in Fruit and Vegetable Consumption | Number of times the child consumed of vegetables and fruits yesterday | Posted | Mean | 95% Confidence Interval | times/day | baseline and 1 year |
|
|
|
|
| Secondary | Change in Consumption of Sugar-sweetened Beverages and Juice | 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. | Posted | Mean | 95% Confidence Interval | times/day | baseline and 1 year |
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| Post-Hoc | Increased Satisfaction With Care at Harvard Vanguard Medical Associates (HVMA) | This is a feasibility and acceptability measure from the study. | 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. | Posted | Count of Participants | Participants | 1 year |
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| Post-Hoc | Parent Very Satisfied With Content of Connect 4 Health Text Messages or Emails. | This is a feasibility and acceptability measure from the study. | 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. | Posted | Count of Participants | Participants | 1 year |
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| Post-Hoc | Received Information From Connect 4 Health About Resources in the Community | This is a feasibility and acceptability measure from the study. | 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. | Posted | Count of Participants | Participants | 1 year |
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| Post-Hoc | Received Text Messages or Emails From Connect 4 Health | This is a feasibility and acceptability measure from the study. | 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. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Post-Hoc | Parent Very Satisfied With Information he/She Received About Resources in the Community | This is a feasibility and acceptability measure from the study. | 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. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 0 |
| 361 |
| 0 |
| 361 |
| EG001 | Health Coaching | 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. | 0 | 360 | 0 | 360 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |