Obesity, Pediatric
Conditions
Keywords
Obesity, House Calls, Pediatric Primary Care, Virtual, Telehealth
Brief summary
This study examines a redesign of pediatric primary care overweight/obesity treatment, augmenting typical in-person visits with: (1) direct-to-patient video telehealth to tailor counseling advice to families, (2) that leverages certified health coaches as a part of the care team, and (3) creates skills building in real-time within the home environment.
Detailed description
Investigators will recruit children with an elevated body mass index (BMI) (85th to \<99th percentile) and a parent. Dyads will participate in a 24-week intervention with a total of 26 contact hours. Dyads will participate in weekly education sessions for the first 12 weeks and bi-weekly sessions for the remaining 12 weeks. Additionally, dyads will participate in weekly exercise sessions. Assessments will consist of anthropometric measures, psychological surveys, and nutritional evaluations. Assessments will be completed at baseline, 3-months and 6-months.
Interventions
BEHAVIORALVirtual Health Coach
Dyads first session will be 60-minutes, totaling 1 hour. Dyads will participate in weekly 30-minute sessions for weeks 2-12, totaling 5.5 hours. Dyads will participate bi-weekly 30-minute sessions for 12 weeks, totaling 3 hours. Dyads will participate in weekly 30-minute exercise sessions for 24-weeks, totaling 12 hours. Children will have 3, 30-minute visits with their primary care physician (PCP) every 3 months, totaling 1.5 hours. Parents will have three, 60-minute individual sessions, totaling 3 hours. Total study duration is 24 weeks, with a total of 26 contact hours. Sessions follow a behavior therapy approach, including guided goal-setting, self-monitoring, identifying barriers and solutions, contingency management, stimulus control, dealing with setbacks, maintenance and relapse prevention. Weight is assessed weekly by coaches, with MI-consistent, autonomy-supportive feedback provided. Parent sessions will focus on ways to support their child's weight management.
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Children: * Ages 9-13 years * BMI 85th to \<99th percentile * Must be a patient within Health System Pediatric Primary Care * Must be English or Spanish speaking Parent: -Must be English or Spanish speaking
Exclusion criteria
Children: * Cannot have an emotional, social, or physical disability that would prevent them from participating in the protocol * Non-English or Non-Spanish speaking * Cannot have a medical condition resulting in unintentional weight gain (i.e. Prader Willi) * Females cannot be pregnant * In addition, children will potentially be excluded from participation if they have a positive screen during an interview led pre-screening eating disorder questionnaire Parent: -Non-English or Non-Spanish speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment of Participants. | 6 months | Percentage of participants recruited compared to goal sample size. |
| Retention of Participants | 6 months | Ability to retain 70% of participants at primary end point. |
| Number of Participants Who Reported Being Satisfied With the Intervention | 6 months | Measured in an exit interview. Participants were asked if they benefited from the program. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dietary Intake | Baseline, 3-, and 6-months | Child participants completed a 24-hour food recall using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool. Total energy intake is reported from the 24-hour recall. |
| Physical Activity. | Baseline, 3-, and 6-months | Engagement in physical activity self-reported by the Patient-Centered Assessment and Counseling for Exercise Plus Nutrition (PACE+) questionnaire. The measure is scored by averaging responses with a range of 0-7. Higher scores (5-7) indicate meeting activity guidelines. |
| Body Mass Index Change | 6 months | Body Mass Index change (kg/m2) from baseline to 6-months for child and parent. National Health and Nutrition Examination Survey (NHANES) Anthropometry methods were used to measure height and weight to calculate Body Mass Index (BMI). |
| Home Food Environment. | Baseline, 3-, and 6-months | The Home Food Inventory (HFI) was used to assess the availability of types of food in the home and calculate an overall obesogenic score. Scores range from 0-60, with high scores indicating a more obesogenic food environment. |
| Parent Reported Sleep Duration for Child | Baseline, 3-month, and 6-month | Parents completed a subset of questions from the National Health and Nutrition Examination Survey (NHANES) regarding their child's sleep behaviors. Data is reported sleep duration (hours) for child on weekdays/school days. |
| Adolescent Reported Authoritative Parenting Style | Baseline, 3-, and 6-months | The Authoritative Parenting Index (API) was used to assess adolescent-report of authoritative parenting style. Scores range from 16-64 with higher scores indicating the adolescent perceives their parent to have a higher level of authoritative parenting behavior. Results reflect the adolescent's perception on their parent (mom or dad) who participated in the study. |
| Parent Reported Parenting Style | Baseline, 3-, and 6-months | The Parenting Styles and Dimension Questionnaire (PSDQ) was administered to parents to assess parent self-report of authoritative parenting style. Results reflect the participating parent's perception of their parenting style. Scores range from 1-5 with higher scoring indicating a greater frequency of authoritative parenting behaviors. |
Countries
United States
Participant flow
Recruitment details
Recruitment for the trial occurred from January 2024 through August 2024. Recruitment methods included physician referrals and direct patient messaging with the electronic health record.
Participants by arm
| Arm | Count |
|---|---|
| Child Children that participated in the Virtual Housecalls behavioral intervention with their parent. | 5 |
| Parent Parents that participated in the Virtual Housecalls behavioral intervention with their child. | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Child | Parent | Total |
|---|---|---|---|
| Age, Continuous | 12.2 years STANDARD_DEVIATION 1.8 | 40.6 years STANDARD_DEVIATION 5.8 | 26.4 years STANDARD_DEVIATION 15.5 |
| Body Mass Index | 25.99 kg/m^2 STANDARD_DEVIATION 3.22 | 33.45 kg/m^2 STANDARD_DEVIATION 3.83 | 29.72 kg/m^2 STANDARD_DEVIATION 5.16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 5 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 5 participants | 5 participants | 10 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Number of Participants Who Reported Being Satisfied With the Intervention
Measured in an exit interview. Participants were asked if they benefited from the program.
Time frame: 6 months
Population: Only participants who participated in an exit interview were included in this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Child | Number of Participants Who Reported Being Satisfied With the Intervention | 3 Participants |
| Parent | Number of Participants Who Reported Being Satisfied With the Intervention | 3 Participants |
Primary
Recruitment of Participants.
Percentage of participants recruited compared to goal sample size.
Time frame: 6 months
Population: The Overall Number of Participants Analyzed reflects the target enrollment number and the data reported reflects the actual number of participants enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Child | Recruitment of Participants. | 5 Participants |
| Parent | Recruitment of Participants. | 5 Participants |
Primary
Retention of Participants
Ability to retain 70% of participants at primary end point.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Child | Retention of Participants | 5 Participants |
| Parent | Retention of Participants | 5 Participants |
Secondary
Adolescent Reported Authoritative Parenting Style
The Authoritative Parenting Index (API) was used to assess adolescent-report of authoritative parenting style. Scores range from 16-64 with higher scores indicating the adolescent perceives their parent to have a higher level of authoritative parenting behavior. Results reflect the adolescent's perception on their parent (mom or dad) who participated in the study.
Time frame: Baseline, 3-, and 6-months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Child | Adolescent Reported Authoritative Parenting Style | 3-months | 26.40 units on a scale | Standard Deviation 2.41 |
| Child | Adolescent Reported Authoritative Parenting Style | 6-months | 27.60 units on a scale | Standard Deviation 4.93 |
| Child | Adolescent Reported Authoritative Parenting Style | Baseline | 26.80 units on a scale | Standard Deviation 6.54 |
Secondary
Body Mass Index Change
Body Mass Index change (kg/m2) from baseline to 6-months for child and parent. National Health and Nutrition Examination Survey (NHANES) Anthropometry methods were used to measure height and weight to calculate Body Mass Index (BMI).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Child | Body Mass Index Change | 1.07 kg/m^2 | Standard Deviation 1.05 |
| Parent | Body Mass Index Change | -0.43 kg/m^2 | Standard Deviation 1.18 |
Secondary
Dietary Intake
Child participants completed a 24-hour food recall using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool. Total energy intake is reported from the 24-hour recall.
Time frame: Baseline, 3-, and 6-months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Child | Dietary Intake | Baseline | 1606 kilocalories | Standard Deviation 440 |
| Child | Dietary Intake | 3-month | 1997 kilocalories | Standard Deviation 1143 |
| Child | Dietary Intake | 6-month | 1224 kilocalories | Standard Deviation 385 |
Secondary
Home Food Environment.
The Home Food Inventory (HFI) was used to assess the availability of types of food in the home and calculate an overall obesogenic score. Scores range from 0-60, with high scores indicating a more obesogenic food environment.
Time frame: Baseline, 3-, and 6-months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Child | Home Food Environment. | Baseline | 15.40 units on a scale | Standard Deviation 14.98 |
| Child | Home Food Environment. | 3-month | 10.60 units on a scale | Standard Deviation 1.52 |
| Child | Home Food Environment. | 6-month | 11.20 units on a scale | Standard Deviation 3.27 |
Secondary
Parent Reported Parenting Style
The Parenting Styles and Dimension Questionnaire (PSDQ) was administered to parents to assess parent self-report of authoritative parenting style. Results reflect the participating parent's perception of their parenting style. Scores range from 1-5 with higher scoring indicating a greater frequency of authoritative parenting behaviors.
Time frame: Baseline, 3-, and 6-months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Child | Parent Reported Parenting Style | Baseline | 4.16 units on a scale | Standard Deviation 0.51 |
| Child | Parent Reported Parenting Style | 3-month | 4.2 units on a scale | Standard Deviation 0.69 |
| Child | Parent Reported Parenting Style | 6-month | 4.25 units on a scale | Standard Deviation 0.71 |
Secondary
Parent Reported Sleep Duration for Child
Parents completed a subset of questions from the National Health and Nutrition Examination Survey (NHANES) regarding their child's sleep behaviors. Data is reported sleep duration (hours) for child on weekdays/school days.
Time frame: Baseline, 3-month, and 6-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Child | Parent Reported Sleep Duration for Child | Baseline | 8.45 hours | Standard Deviation 1.12 |
| Child | Parent Reported Sleep Duration for Child | 3-month | 8.55 hours | Standard Deviation 1.303 |
| Child | Parent Reported Sleep Duration for Child | 6-month | 9.10 hours | Standard Deviation 0.96 |
Secondary
Physical Activity.
Engagement in physical activity self-reported by the Patient-Centered Assessment and Counseling for Exercise Plus Nutrition (PACE+) questionnaire. The measure is scored by averaging responses with a range of 0-7. Higher scores (5-7) indicate meeting activity guidelines.
Time frame: Baseline, 3-, and 6-months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Child | Physical Activity. | Baseline | 3.7 units on a scale | Standard Deviation 1.6 |
| Child | Physical Activity. | 3-month | 4.3 units on a scale | Standard Deviation 1.6 |
| Child | Physical Activity. | 6-month | 3.5 units on a scale | Standard Deviation 1.3 |