Trial Outcomes & Findings for Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes (NCT NCT02124460)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

721 participants

Primary outcome timeframe

baseline and one year

Results posted on

2017-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	361	360
Overall Study COMPLETED	328	336
Overall Study NOT COMPLETED	33	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enhanced Primary Care n=361 Participants 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.	Health Coaching n=360 Participants 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 n=721 Participants Total of all reporting groups
Age, Categorical <=18 years	361 Participants n=5 Participants	360 Participants n=7 Participants	721 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	8.0 years STANDARD_DEVIATION 3.0 • n=5 Participants	8.1 years STANDARD_DEVIATION 3.0 • n=7 Participants	8.0 years STANDARD_DEVIATION 3.0 • n=5 Participants
Sex: Female, Male Female	188 Participants n=5 Participants	180 Participants n=7 Participants	368 Participants n=5 Participants
Sex: Female, Male Male	173 Participants n=5 Participants	180 Participants n=7 Participants	353 Participants n=5 Participants
Region of Enrollment United States	361 participants n=5 Participants	360 participants n=7 Participants	721 participants n=5 Participants
BMI z score	1.90 BMI z score units STANDARD_DEVIATION 0.51 • n=5 Participants	1.86 BMI z score units STANDARD_DEVIATION 0.52 • n=7 Participants	1.88 BMI z score units STANDARD_DEVIATION 0.52 • n=5 Participants
Pediatric Quality of Life (PedsQL) Summary Score	86.0 units on a scale STANDARD_DEVIATION 10.8 • n=5 Participants	85.4 units on a scale STANDARD_DEVIATION 11.4 • n=7 Participants	85.7 units on a scale STANDARD_DEVIATION 11.1 • n=5 Participants
Parent Resource Empowerment	2.93 units on a scale STANDARD_DEVIATION 0.59 • n=5 Participants	2.96 units on a scale STANDARD_DEVIATION 0.53 • n=7 Participants	2.95 units on a scale STANDARD_DEVIATION 0.56 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enhanced Primary Care n=361 Participants 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.	Health Coaching n=360 Participants 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.
Change in BMI z Score	-0.06 BMI z score units Interval -0.1 to -0.02	-0.09 BMI z score units Interval -0.13 to -0.05

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enhanced Primary Care n=361 Participants 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.	Health Coaching n=360 Participants 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.
Change in Quality of Life	0.65 units on a scale Interval -0.38 to 1.67	1.53 units on a scale Interval 0.51 to 2.56

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enhanced Primary Care n=361 Participants 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.	Health Coaching n=360 Participants 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.
Change in Parent Resource Empowerment	0.29 units on a scale Interval 0.22 to 0.35	0.22 units on a scale Interval 0.15 to 0.29

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enhanced Primary Care n=361 Participants 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.	Health Coaching n=360 Participants 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.
Change in Screen Time	-0.06 hours/day Interval -0.12 to 0.0	-0.56 hours/day Interval -0.78 to -0.34

SECONDARY outcome

Timeframe: baseline and 1 year

Average hours/day spent sleeping

Outcome measures

Outcome measures
Measure	Enhanced Primary Care n=361 Participants 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.	Health Coaching n=360 Participants 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.
Change in Sleep	-0.02 hours/day Interval -0.16 to 0.12	0.40 hours/day Interval 0.25 to 0.55

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enhanced Primary Care n=361 Participants 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.	Health Coaching n=360 Participants 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.
Change in Physical Activity	0.15 days/week Interval -0.1 to 0.4	0.33 days/week Interval 0.09 to 0.58

SECONDARY outcome

Timeframe: baseline and 1 year

Number of times the child consumed of vegetables and fruits yesterday

Outcome measures

Outcome measures
Measure	Enhanced Primary Care n=361 Participants 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.	Health Coaching n=360 Participants 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.
Change in Fruit and Vegetable Consumption	0.19 times/day Interval 0.01 to 0.36	0.50 times/day Interval 0.33 to 0.68

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enhanced Primary Care n=361 Participants 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.	Health Coaching n=360 Participants 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.
Change in Consumption of Sugar-sweetened Beverages and Juice	-0.03 times/day Interval -0.2 to 0.14	-0.25 times/day Interval -0.41 to -0.08

POST_HOC outcome

Timeframe: 1 year

Population: 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.