Obesity
Conditions
Keywords
Disparities, Stakeholder engagement, Social determinants of health, Healthcare delivery
Brief summary
The goal of this clinical trial is to evaluate a new way of providing healthcare to children with an unhealthy weight. Families who participate will be assigned by chance to one of two groups. One group will see their child's primary care provider to talk about healthy lifestyles for 6 months. The other group will be in our Healthy Lifestyle program for 6 months. This will include: * Check-ins with lifestyle specialists and community health workers, * A mobile app to help support a healthy lifestyle, and * Access to community programs and activities. The main questions the study aims to answer are: * Do children in the Healthy Lifestyle program have better weight outcomes? * Do more families in the Healthy Lifestyle program stay in the study? * Does the Healthy Lifestyle program work better for families from certain communities?
Interventions
BEHAVIORALHealthy Lifestyle
Healthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month.
BEHAVIORALStandard of Care
Weight checks and lifestyle counseling with primary care provider every other month.
Sponsors
National Institute of General Medical Sciences (NIGMS)
Nemours Children's Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Caregiver and child dyads will be enrolled Inclusion Criteria: * Child 4-12 years of age * Child is a patient of the Nemours Children's Health primary care clinics in Milford, Seaford, and Millsboro * Child has a BMI ≥ 95% for age and sex * Child is from a clinic serving rural neighborhoods (RUCA ≥ 4)
Exclusion criteria
* Caregiver not child's legal guardian * Caregiver not proficient in English or Spanish * Caregiver does not have a device and reliable internet * Child has a genetic syndrome or endocrine disorder that predisposes to obesity * Child is on a medication that impacts weight * Child is already enrolled in a weight management program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Child Adiposity | 6 months | Change in BMI percentile (above the 95th percentile) for age and sex. Height and weight measurements will be used to calculate BMI percentile above the 95th percentile based on CDC algorithms. |
| Visit Adherence | 6 months | Lost to follow-up (attrition) from study as documented in the electronic health record. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics | 6 months | Differences in change in BMI percentile (above the 95th percentile) for age and sex between subgroups based on race, ethnicity, and insurance status. Height and weight measurements will be used to calculate BMI percentile above the 95th percentile based on CDC algorithms. Child race, ethnicity, and insurance status will be collected from parents at the time of enrollment. |
| Differences in Visit Adherence Based on Child Sociodemographic Characteristics | 6 months | Differences in lost to follow-up (attrition) from study as documented in the electronic health record between subgroups based on race, ethnicity, and insurance status. Child race, ethnicity, and insurance status will be collected from parents at the time of enrollment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Lifestyle Healthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month. | 29 |
| Standard of Care Weight checks and lifestyle counseling with primary care provider every other month. | 30 |
| Total | 59 |
Baseline characteristics
| Characteristic | Healthy Lifestyle | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 9.1 Years STANDARD_DEVIATION 2.5 | 8.2 Years STANDARD_DEVIATION 2.6 | 8.6 Years STANDARD_DEVIATION 2.6 |
| BMI percentile above the 95th percentile | 119.4 BMI percentile above the 95th percentile STANDARD_DEVIATION 14.2 | 123.9 BMI percentile above the 95th percentile STANDARD_DEVIATION 19.8 | 121.8 BMI percentile above the 95th percentile STANDARD_DEVIATION 17.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 8 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 22 Participants | 43 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 | 10 Participants | 11 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 8 Participants | 16 Participants |
| Race (NIH/OMB) White | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Female | 14 Participants | 14 Participants | 28 Participants |
| Sex: Female, Male Male | 15 Participants | 16 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 30 |
| other Total, other adverse events | 0 / 29 | 0 / 30 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 |
Outcome results
Primary
Change in Child Adiposity
Change in BMI percentile (above the 95th percentile) for age and sex. Height and weight measurements will be used to calculate BMI percentile above the 95th percentile based on CDC algorithms.
Time frame: 6 months
Population: 7 participants did not have anthropometric measurements collected in the EHR at the end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Lifestyle | Change in Child Adiposity | -0.55 Change in BMI percentile | Standard Deviation 7.18 |
| Standard of Care | Change in Child Adiposity | 0.64 Change in BMI percentile | Standard Deviation 5.3 |
Primary
Visit Adherence
Lost to follow-up (attrition) from study as documented in the electronic health record.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Lifestyle | Visit Adherence | 8 Participants |
| Standard of Care | Visit Adherence | 8 Participants |
Secondary
Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics
Differences in change in BMI percentile (above the 95th percentile) for age and sex between subgroups based on race, ethnicity, and insurance status. Height and weight measurements will be used to calculate BMI percentile above the 95th percentile based on CDC algorithms. Child race, ethnicity, and insurance status will be collected from parents at the time of enrollment.
Time frame: 6 months
Population: 7 participants did not have anthropometric measures recorded in the EHR at baseline and study end due to lost to follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Lifestyle | Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics | Non-Hispanic Black | 0.81 Change in BMI percentile | Standard Deviation 4.61 |
| Healthy Lifestyle | Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics | Private Insurance | -1.64 Change in BMI percentile | Standard Deviation 2.16 |
| Healthy Lifestyle | Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics | Hispanic or Latino | -1.90 Change in BMI percentile | Standard Deviation 9.68 |
| Healthy Lifestyle | Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics | Public Insurance | -0.28 Change in BMI percentile | Standard Deviation 7.99 |
| Healthy Lifestyle | Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics | Non-Hispanic White | -0.56 Change in BMI percentile | Standard Deviation 7.11 |
| Standard of Care | Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics | Public Insurance | 0.89 Change in BMI percentile | Standard Deviation 5.02 |
| Standard of Care | Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics | Non-Hispanic White | -0.09 Change in BMI percentile | Standard Deviation 6.83 |
| Standard of Care | Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics | Non-Hispanic Black | 1.67 Change in BMI percentile | Standard Deviation 4.38 |
| Standard of Care | Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics | Hispanic or Latino | -0.04 Change in BMI percentile | Standard Deviation 4.43 |
| Standard of Care | Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics | Private Insurance | 0.04 Change in BMI percentile | Standard Deviation 6.24 |
Secondary
Differences in Visit Adherence Based on Child Sociodemographic Characteristics
Differences in lost to follow-up (attrition) from study as documented in the electronic health record between subgroups based on race, ethnicity, and insurance status. Child race, ethnicity, and insurance status will be collected from parents at the time of enrollment.
Time frame: 6 months
Population: Number analyzed in rows below are only those who were lost to follow-up (attrition) for each race, ethnicity, or insurance category
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Healthy Lifestyle | Differences in Visit Adherence Based on Child Sociodemographic Characteristics | Non-Hispanic Black | Attrition | 5 Participants |
| Healthy Lifestyle | Differences in Visit Adherence Based on Child Sociodemographic Characteristics | Non-Hispanic Black | Non-Attrition | 5 Participants |
| Healthy Lifestyle | Differences in Visit Adherence Based on Child Sociodemographic Characteristics | Non-Hispanic White | Attrition | 3 Participants |
| Healthy Lifestyle | Differences in Visit Adherence Based on Child Sociodemographic Characteristics | Non-Hispanic White | Non-Attrition | 8 Participants |
| Healthy Lifestyle | Differences in Visit Adherence Based on Child Sociodemographic Characteristics | Hispanic or Latino | Attrition | 0 Participants |
| Healthy Lifestyle | Differences in Visit Adherence Based on Child Sociodemographic Characteristics | Hispanic or Latino | Non-Attrition | 8 Participants |
| Standard of Care | Differences in Visit Adherence Based on Child Sociodemographic Characteristics | Hispanic or Latino | Attrition | 3 Participants |
| Standard of Care | Differences in Visit Adherence Based on Child Sociodemographic Characteristics | Non-Hispanic Black | Attrition | 4 Participants |
| Standard of Care | Differences in Visit Adherence Based on Child Sociodemographic Characteristics | Non-Hispanic White | Non-Attrition | 10 Participants |
| Standard of Care | Differences in Visit Adherence Based on Child Sociodemographic Characteristics | Non-Hispanic Black | Non-Attrition | 7 Participants |
| Standard of Care | Differences in Visit Adherence Based on Child Sociodemographic Characteristics | Hispanic or Latino | Non-Attrition | 5 Participants |
| Standard of Care | Differences in Visit Adherence Based on Child Sociodemographic Characteristics | Non-Hispanic White | Attrition | 1 Participants |