Childhood Obesity Treatment Designed for Low Income and Hispanic Families

Sponsor

University of Colorado, Denver (Other)

Overall Status

Recruiting

CT.gov ID

NCT05041855

Collaborator

Colorado State University (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

658

Enrollment

Locations

Arms

66.5

Anticipated Duration (Months)

329

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a type-1 hybrid effectiveness-implementation RCT comparing a novel family-inclusive childhood obesity treatment program, the "Healthy Living Program" (HeLP), to a protocol that enhances usual primary care to deliver Recommended Treatment of Obesity in Primary Care (RTOP). Children with obesity and their families will be referred to the study by primary care providers and randomized to HeLP or RTOP. The clinical setting is a practice-based research network serving majority Hispanic and Medicaid-insured populations. The intensive phase and booster sessions of HeLP will take place at recreation centers located near the clinics and will be led by health educators employed by the clinics. Visits with primary care providers (PCPs) for HeLP maintenance or RTOP will occur at the clinics.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Obesity Healthy Eating Physical Activity Minority Health Mindfulness Family Counseling	Behavioral: The Healthy Living Program/La Vida Saludable Behavioral: Recommended Treatment of Obesity in Primary Care	N/A

Detailed Description

This study is a Randomized Controlled Trial (RCT) to learn about how well a family childhood weight management program works compared to healthy lifestyle counseling by providers at participating clinics. The goal is to compare weight change in children with obesity from low-income predominantly Hispanic/Latino families that will participate in the program, the Healthy Living Program (HeLP) vs. Recommended Treatment of Obesity in Primary Care (RTOP). Low-income children with obesity from mostly Hispanic clinical populations will be referred to the project by their primary doctors and will be enrolled into either HeLP or RTOP. Families (including siblings and caregivers) who are in HeLP will be offered 12 sessions at local rec centers where health educators and fitness trainers will teach them about parenting skills, nutrition, fitness, and mindfulness. Families who are in RTOP will receive an enhanced version of the care that is usually provided at their primary care clinics. Providers will be trained in a skill called Motivational Interviewing and use an electronic tool called "HeartSmartKids" to help families make healthy lifestyle changes. Families who are in RTOP will go to follow-up visits every 3 months and will go to HeLP after 18 months.

Aim 1 (Treatment): To compare the BMI change relative to the 95th percentile for age and sex in children with obesity in 3 different age groups (2-6, 7-12, and 13-16 years old) 18 months after being in either HeLP or RTOP.

Aim 2 (Prevention): To compare the weight change in healthy and unhealthy weight 2-6-year-old children who have siblings with obesity and are in either HeLP or RTOP.

Aim 3 (Implementation): To describe implementation processes of HeLP and RTOP using a framework called RE-AIM: R-Reach: Is the project reaching the people it needs to reach? E-Effectiveness: Is the program effective? A-Adoption: are the health educators, providers, and clinics promoting and doing the program? I-Implementation: Are the health educators, providers and clinics delivering the intervention as intended? M-Maintenance: Is the intervention working to help children with their weight and healthy lifestyle changes? The cost of delivering the program will also be studied to inform potential sustainability.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

658 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Family participants (children and their caregivers) will be randomized to the Healthy Living Program group intervention or the Recommended Treatment of Obesity in Primary Care individual intervention for an observation period of 18 months from baseline.Family participants (children and their caregivers) will be randomized to the Healthy Living Program group intervention or the Recommended Treatment of Obesity in Primary Care individual intervention for an observation period of 18 months from baseline.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Family Inclusive Childhood Obesity Treatment Designed for Low Income and Hispanic Families

Actual Study Start Date :

Nov 15, 2021

Anticipated Primary Completion Date :

May 31, 2026

Anticipated Study Completion Date :

May 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Community based childhood obesity intervention A novel family-inclusive childhood obesity treatment program consisting of 12 family group sessions delivered in English and Spanish by health educators at community recreation centers, followed by three group booster sessions occurring every 6 months.	Behavioral: The Healthy Living Program/La Vida Saludable A whole-family group childhood obesity intervention delivered at community recreation centers Other Names: HeLP
Active Comparator: Primary care based childhood obesity intervention A healthy lifestyle counseling intervention delivered by trained primary care providers and health educators at visits occurring every 3 months.	Behavioral: Recommended Treatment of Obesity in Primary Care A healthy lifestyle counseling protocol that enhances usual primary care Other Names: RTOP

Arm

Intervention/Treatment

Experimental: Community based childhood obesity intervention

A novel family-inclusive childhood obesity treatment program consisting of 12 family group sessions delivered in English and Spanish by health educators at community recreation centers, followed by three group booster sessions occurring every 6 months.

Behavioral: The Healthy Living Program/La Vida Saludable

A whole-family group childhood obesity intervention delivered at community recreation centers

Other Names:

HeLP

Active Comparator: Primary care based childhood obesity intervention

A healthy lifestyle counseling intervention delivered by trained primary care providers and health educators at visits occurring every 3 months.

Behavioral: Recommended Treatment of Obesity in Primary Care

A healthy lifestyle counseling protocol that enhances usual primary care

Other Names:

RTOP

Outcome Measures

Primary Outcome Measures

Change in Body Mass Index (BMI) %95 in children with obesity (treatment) [From Baseline to Month 18]
Change in BMI%95 as measured in 2-16 yr old children with obesity BMI%95 is the percentage a child's BMI represents of the BMI value at the 95th percentile for age and sex calculated using the Centers for Disease Control (CDC) program for Statistical Analysis System (SAS).
Change in Body Mass Index (BMI) %95 in healthy and overweight children (prevention) [From Baseline to Month 18]
Change in BMI%95 as measured in healthy and overweight 2-11 yr old siblings of the children with obesity. BMI%95 is the percentage a child's BMI represents of the BMI value at the 95th percentile for age and sex calculated using the CDC program for SAS.

Secondary Outcome Measures

Change in Body Mass Index (BMI) %95 in children with obesity (treatment) [From Baseline to Month 12]
Change in BMI%95 as measured in 2-16 yr old children with obesity BMI%95 is the percentage a child's BMI represents of the BMI value at the 95th percentile for age and sex calculated using the CDC program for SAS.
Change in Body Mass Index (BMI) %95 in healthy and overweight children (prevention) [From Baseline to Month 12]
Change in BMI%95 as measured in healthy and overweight 2-11 yr old siblings of the children with obesity. BMI%95 is the percentage a child's BMI represents of the BMI value at the 95th percentile for age and sex calculated using the CDC program for SAS.
Change in nutrition aspects of the home environment as measured by the Comprehensive Home Environment Survey (CHES) [Baseline, Month 18]
The CHES is a validated parent-report instrument that measures aspects of the home environment influencing child diet and physical activity. Possible scores on the nutrition scale range from 0 to 10, with higher scores indicating a better home environment for nutrition.
Change in physical activity and media aspects of the home environment as measured by the Comprehensive Home Environment Survey (CHES) [Baseline, Month 18]
The CHES is a validated parent-report instrument that measures aspects of the home environment influencing physical activity and media. Possible scores are on a scale from 0 to 8 with higher scores indicating a better home environment for physical activity and media.
Change from Baseline in food insecurity at 18 months as measured by the US Department of Agriculture (USDA) Household Food Security Survey scores [Baseline, Month 18]
The USDA Household Food Security Survey is a validated scale that measures food insecurity. Possible scores range from 0 to 18, with higher scores indicating lower food security.
Change from baseline in Hunger at 18 months as measured by the Three-Factor Eating Questionnaire for Children and Adolescents [Baseline, Month 18]
Three-Factor Eating Questionnaire for Children and Adolescents is a validated scale that measures eating attitudes and behaviors in 3 domains: 'Cognitive Restraint of Eating', 'Disinhibition', and 'Hunger'. Possible scores range from 0-14 for 'Hunger' with higher scores indicating worse eating attitudes and behaviors.
Change from baseline in Cognitive Restraint of Eating at 18 months as measured by the Three-Factor Eating Questionnaire for Children and Adolescents [Baseline, Month 18]
Three-Factor Eating Questionnaire for Children and Adolescents is a validated scale that measures eating attitudes and behaviors in 3 domains: 'Cognitive Restraint of Eating', 'Disinhibition', and 'Hunger'. Possible scores range from 0-21 for 'Cognitive Restraint of Eating' with higher scores indicating worse eating attitudes and behaviors.
Change from baseline in Disinhibition at 18 months as measured by the Three-Factor Eating Questionnaire for Children and Adolescents [Baseline, Month 18]
Three-Factor Eating Questionnaire for Children and Adolescents is a validated scale that measures eating attitudes and behaviors in 3 domains: 'Cognitive Restraint of Eating', 'Disinhibition', and 'Hunger'. Possible scores range from 0-16 for 'Disinhibition' with higher scores indicating worse eating attitudes and behaviors.
Change from baseline in physical fitness at 6 months as measured by the Progressive Aerobic Cardiovascular Endurance Run (PACER) Scores [Baseline, Month 6]
The Progressive Aerobic Cardiovascular Endurance Run (PACER) test measures physical fitness by estimating VO2peak. Scores are based on a shuttle-run of 20 meter intervals. The higher the number of intervals completed in the allotted time indicating a better outcome.
Change from baseline in physical fitness at 18 months as measured by the Progressive Aerobic Cardiovascular Endurance Run (PACER) Scores [Baseline, Month 18]
The Progressive Aerobic Cardiovascular Endurance Run (PACER) test measures physical fitness by estimating VO2peak. Scores are based on a shuttle-run of 20 meter intervals. The higher the number of intervals completed in the allotted time indicating a better outcome.
Change from Baseline in Hemoglobin A1c (HbA1c) blood glucose tests at 18 months [Baseline up to Month 18]
HbA1c blood glucose test, routinely measured as part of pediatric well child care for children 10 years and older with obesity, measures the average level of glucose in blood with normal range 4.2% to 5.6%, prediabetes range 5.7% to 6.4%, and ≥6.5% indicating diabetes. Higher numerical values above 5.7 indicate worse blood sugar control. Investigators will compare the mean A1c between the two groups.
Change from Baseline in Alanine Transaminase (ALT) liver enzyme levels tests at 18 months [Baseline up to Month 18]
ALT levels in the blood, routinely measured as part of pediatric well child care for children 10 years and older with obesity, is measured by milligrams per deciliter (mg/dl) with ALT>22mg/dL in females less than 18 years, and ALT >26 mg/dL in males less than 18 years indicating possible non-alcoholic fatty liver disease. Higher levels of ALT above these normal cutoffs may represent worsening liver disease. Investigators will compare the mean ALT between the two groups.
Change from Baseline in Low Density Lipoprotein (LDL) Cholesterol tests or fasting lipids tests at 18 months [Baseline up to Month 18]
The LDL blood test, routinely measured as part of pediatric well child care for children 10 years and older with obesity, measures cholesterol with an LDL>110 mg/dL in children indicating a worse outcome such as increased long-term risk of heart disease. Higher levels of LDL above these normal cutoffs may represent higher risk of heart disease. Investigators will compare the mean LDL between the two groups.
Change from Baseline in Caregiver Waist Circumference (WC) at 12 months [Baseline, Month 12]
Waist Circumference is measured to classify adults aged 20 or older into 3 health risk categories, low health risk, increased health risk, and high health risk. A higher waist circumference indicates a worse outcome.
Change from Baseline in Caregiver Waist Circumference (WC) at 18 months [Baseline, Month 18]
Waist Circumference is measured to classify adults aged 20 or older into 3 health risk categories, low health risk, increased health risk, and high health risk. A higher waist circumference indicates a worse outcome.
Change from Baseline in Adult Caregiver Body Mass Index (BMI) at 12 months [Baseline, Month 12]
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of their height in meters. Scores between 18.5 and 24.9 indicate a healthy weight. A higher BMI indicates a worse outcome.
Change from Baseline in Adult Caregiver Body Mass Index (BMI) at 18 months [Baseline, Month 18]
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of their height in meters. Scores between 18.5 and 24.9 indicate a healthy weight. A higher BMI indicates a worse outcome.
Change from Baseline to 6 months in levels of Familism as measured by the Pan-Hispanic Familism Scale [Baseline, Month 6]
The Pan-Hispanic Familism Scale is a validated scale that measures familism, a value system found within many Hispanic/Latino communities that emphasizes familial honor, respect, and mutual collaboration. Participants respond on a 5-point Likert scale from 1=Strongly disagree to 5=Strongly Agree. Higher Scores indicate a higher degree of adherence to Familism.
Change from Baseline in 18 months in levels of Familism as measured by the Pan-Hispanic Familism Scale [Baseline, Month 18]
The Pan-Hispanic Familism Scale is a validated scale that measures familism, a value system found within many Hispanic/Latino communities that emphasizes familial honor, respect, and mutual collaboration. Participants respond on a 5-point Likert scale from 1=Strongly disagree to 5=Strongly Agree. Higher Scores indicate a higher degree of adherence to Familism.
Change from Baseline in weight-related quality of life at 6 months as measured by the Sizing Me Up child report [Baseline, Month 6]
Sizing Me Up is a validated weight-related quality of life questionnaire for children aged 10 years and older. Possible scores range from 0 to 100 with higher scores indicating a better quality of life.
Change from Baseline in weight-related quality of life at 18 months as measured by the Sizing Me Up child report [Baseline, Month 18]
Sizing Me Up is a validated weight-related quality of life questionnaire for children aged 10 years and older. Possible scores range from 0 to 100 with higher scores indicating a better quality of life.
Change from Baseline in weight-related quality of life at 6 months as measured by the Sizing Them Up Parent report [Baseline, Month 6]
Sizing Them Up is a validated weight-related quality of life questionnaire for parents/primary caregivers of children 6 to 10 years of age. Possible scores range from 0 to 100 with higher scores indicating a better quality of life.
Change from Baseline in weight-related quality of life at 18 months as measured by the Sizing Them Up Parent report [Baseline, Month 18]
Sizing Them Up is a validated weight-related quality of life questionnaire for parents/primary caregivers of children 6 to 10 years of age. Possible scores range from 0 to 100 with higher scores indicating a better quality of life.
Change from Baseline in depressive symptoms in parents at 6 months as measured by the Center of Epidemiological Studies Depression Scale (CES-D) [Baseline, Month 6]
The Center of Epidemiological Studies Depression Scale is a validated questionnaire that assesses depressive symptoms in parents. Possible scores range from 0-60 with higher scores indicating worse depressive symptoms.
Change from Baseline in depressive symptoms in parents at 18 months as measured by the Center of Epidemiological Studies Depression Scale (CES-D) [Baseline, Month 18]
The Center of Epidemiological Studies Depression Scale is a validated questionnaire that assesses depressive symptoms in parents. Possible scores range from 0-60 with higher scores indicating worse depressive symptoms.
Change from Baseline in depressive symptoms in adolescents 12-18 years at 6 months as measured by the Center of Epidemiological Studies Depression Scale (CES-D) [Baseline, Month 6]
The Center of Epidemiological Studies Depression Scale is a validated questionnaire that assesses depressive symptoms in adolescents 12-18 years. Possible scores range from 0-60 with higher scores indicating worse depressive symptoms.
Change from Baseline in depressive symptoms in adolescents 12-18 years at 18 months as measured by the Center of Epidemiological Studies Depression Scale (CES-D) [Baseline, Month 18]
The Center of Epidemiological Studies Depression Scale is a validated questionnaire that assesses depressive symptoms in adolescents 12-18 years. Possible scores range from 0-60 with higher scores indicating worse depressive symptoms.
Change from Baseline in depressive symptoms in children at 6 months as measured by the Center of Epidemiological Studies Depression Scale for Children 6-12 years (CES-DC) [Baseline, Month 6]
The Center of Epidemiological Studies Depression Scale for Children is a validated questionnaire that measures depressive symptoms in 6-12 year old children. Possible scores range from 0-60 with higher scores indicating worse depressive symptoms.
Change from Baseline in depressive symptoms in children at 18 months as measured by the Center of Epidemiological Studies Depression Scale for Children 6-12 years (CES-DC) [Baseline, Month 18]
The Center of Epidemiological Studies Depression Scale for Children is a validated questionnaire that measures depressive symptoms in 6-12 year old children. Possible scores range from 0-60 with higher scores indicating worse depressive symptoms.
Reach as measured by the proportion of eligible children seen for well-child care that are randomized. [up to Month 18]
Reach as measured by the proportion of children seen for a well-child check at each clinic that are randomized during the study.
Adoption as measured by the proportion of training sessions attended by medical providers [up to month 48]
Number of training sessions that Primary Care Providers attend. Attendance will be taken at all PCP trainings. There will be 4 training sessions within the first 12 months and 2 refresher training sessions between 36-48 months. Total 6 possible sessions attended, with higher attendance rates indicating a better outcome.
Primary Care Visit Frequency in the as measured by number of clinic visits for each child [up to month 36]
Primary Care Visit Frequency, as measured by the number of clinic visits for child weight follow-up reported in Clinic Electronic Medical Records (EMR's.
Change in history of Coronavirus Disease 2019 (COVID-19) diagnosis status in a parent participant [Baseline, up to month 18]
Response to questionnaire administered every 6 months throughout the study period to participating parents querying whether they or any of their participating children have tested positive for COVID-19 using a laboratory assay. Participants with no history of COVID-19 diagnosis at baseline who later report positive diagnosis will be defined as new diagnosis of COVID-19 during the study period.
Change in history of COVID-19 diagnosis status in a child participant [Baseline, up to month 18]
Response to questionnaire administered every 6 months throughout the study period to participating parents querying whether any of their participating children have tested positive for COVID-19 using a laboratory assay. Child participants with no history of COVID-19 diagnosis at baseline whose parents later report positive diagnosis for that child will be defined as new diagnosis of COVID-19 during the study period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Child aged 2-16yrs
With overweight or obesity (BMI >85th percentile)
Referred by PCP
Primary Adult Caregiver
Up to two siblings of any BMI status (if multiple siblings are available, enrollment goals stratified by age and BMI will be used to select siblings for enrollment.)

Exclusion Criteria:

Parent without fluency in either Spanish or English
Current participation in a clinically referred obesity treatment program
Child non-ambulatory, non-verbal, or diagnosed with a genetic syndrome associated with obesity.
Children with severe depression on initial screening (CES-D >/=40 or suicidal ideation) will be excluded and referred to psychiatric treatment and therapy.
Children who have been diagnosed by PCP at time of initial screening with severe comorbidities of obesity, including:
Type 2 diabetes
Stage 2 hypertension
Severe hyperlipidemia
Severe obstructive sleep apnea will be excluded from the study and directed to the only Tertiary Care Childhood Obesity Treatment program in the state of Colorado: Lifestyle Medicine at Children's Hospital Colorado.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Anschutz	Aurora	Colorado	United States	80045
2	Colorado State University-College of Health and Human Sciences	Fort Collins	Colorado	United States	80523