Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes

Improving Childhood Obesity Outcomes: Testing Best Practices of Positive Outliers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02124460

Enrollment

721

Registered

2014-04-28

Start date

2014-06-30

Completion date

2016-11-30

Last updated

2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

Pediatric, Obesity, Overweight, Intervention

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 Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity.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 4. To examine the extent to which neighborhood environments modify observed intervention effects 5. To assess the documentation of Healthcare Effectiveness Data and Information Set (HEDIS) measures in participant medical records

Interventions

BEHAVIORALHealth 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to 12 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.
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.
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

Measure	Time frame	Description
Change in Fruit and Vegetable Consumption	baseline and 1 year	Number of times the child consumed of vegetables and fruits yesterday
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.
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.
Change in Sleep	baseline and 1 year	Average hours/day spent sleeping
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	361
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.	360
Total	721

Baseline characteristics

Characteristic	Enhanced Primary Care	Health Coaching	Total
Age, Categorical <=18 years	361 Participants	360 Participants	721 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Age, Continuous	8.0 years STANDARD_DEVIATION 3	8.1 years STANDARD_DEVIATION 3	8.0 years STANDARD_DEVIATION 3
BMI z score	1.90 BMI z score units STANDARD_DEVIATION 0.51	1.86 BMI z score units STANDARD_DEVIATION 0.52	1.88 BMI z score units STANDARD_DEVIATION 0.52
Parent Resource Empowerment	2.93 units on a scale STANDARD_DEVIATION 0.59	2.96 units on a scale STANDARD_DEVIATION 0.53	2.95 units on a scale STANDARD_DEVIATION 0.56
Pediatric Quality of Life (PedsQL) Summary Score	86.0 units on a scale STANDARD_DEVIATION 10.8	85.4 units on a scale STANDARD_DEVIATION 11.4	85.7 units on a scale STANDARD_DEVIATION 11.1
Region of Enrollment United States	361 participants	360 participants	721 participants
Sex: Female, Male Female	188 Participants	180 Participants	368 Participants
Sex: Female, Male Male	173 Participants	180 Participants	353 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 361	0 / 360
serious Total, serious adverse events	0 / 361	0 / 360

Outcome results

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.

Time frame: baseline and one year

Arm	Measure	Value (MEAN)
Enhanced Primary Care	Change in BMI z Score	-0.06 BMI z score units
Health Coaching	Change in BMI z Score	-0.09 BMI z score units

p-value: 0.392895% CI: [-0.08, 0.03]Linear repeated measures

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.

Time frame: Baseline to one-year follow-up

Arm	Measure	Value (MEAN)
Enhanced Primary Care	Change in Parent Resource Empowerment	0.29 units on a scale
Health Coaching	Change in Parent Resource Empowerment	0.22 units on a scale

p-value: 0.1495% CI: [-0.02, 0.16]Linear repeated measures

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.

Time frame: baseline and one year

Arm	Measure	Value (MEAN)
Enhanced Primary Care	Change in Quality of Life	0.65 units on a scale
Health Coaching	Change in Quality of Life	1.53 units on a scale

p-value: 0.230695% CI: [-0.56, 2.33]Linear repeated measures

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.

Time frame: baseline and 1 year

Arm	Measure	Value (MEAN)
Enhanced Primary Care	Change in Consumption of Sugar-sweetened Beverages and Juice	-0.03 times/day
Health Coaching	Change in Consumption of Sugar-sweetened Beverages and Juice	-0.25 times/day

p-value: 0.079295% CI: [-0.45, 0.03]Linear repeated measures

Secondary

Change in Fruit and Vegetable Consumption

Number of times the child consumed of vegetables and fruits yesterday

Time frame: baseline and 1 year

Arm	Measure	Value (MEAN)
Enhanced Primary Care	Change in Fruit and Vegetable Consumption	0.19 times/day
Health Coaching	Change in Fruit and Vegetable Consumption	0.50 times/day

p-value: 0.011395% CI: [0.07, 0.56]Linear repeated measures

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.

Time frame: baseline and 1 year

Arm	Measure	Value (MEAN)
Enhanced Primary Care	Change in Physical Activity	0.15 days/week
Health Coaching	Change in Physical Activity	0.33 days/week

p-value: 0.304395% CI: [-0.16, 0.53]Linear repeated measures

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.

Time frame: baseline and one year

Arm	Measure	Value (MEAN)
Enhanced Primary Care	Change in Screen Time	-0.06 hours/day
Health Coaching	Change in Screen Time	-0.56 hours/day

p-value: 0.001695% CI: [-0.81, -0.19]Linear repeated measures

Secondary

Change in Sleep

Average hours/day spent sleeping

Time frame: baseline and 1 year

Arm	Measure	Value (MEAN)
Enhanced Primary Care	Change in Sleep	-0.02 hours/day
Health Coaching	Change in Sleep	0.40 hours/day

p-value: <0.000195% CI: [0.22, 0.62]Linear repeated measures

Post Hoc