Pediatric ObesityNCT05041855

Childhood Obesity Treatment Designed for Low Income and Hispanic Families

A study testing The Healthy Living Program/La Vida Saludable and Recommended Treatment of Obesity in Primary Care in people with Pediatric Obesity and Healthy Eating, run by University of Colorado, Denver at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 2 years and olderHealthy volunteers can take part
Conditions the study is for: Pediatric Obesity, Healthy Eating, Physical Activity
What is being tested?: The Healthy Living Program/La Vida Saludable and Recommended Treatment of Obesity in Primary Care
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 554 participants
Where: 2 sitesUnited States
Study dates: 15 Nov 2021to 31 May 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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.)

Who cannot join

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

Show all 9Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Colorado Anschutz
Aurora, Colorado, 80045
Colorado State University-College of Health and Human Sciences
Fort Collins, Colorado, 80523

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Pediatric Obesity, Healthy Eating, Physical Activity, Minority Health, Mindfulness, Family
Being tested: The Healthy Living Program/La Vida Saludable, Recommended Treatment of Obesity in Primary Care
Keywords: Childhood Obesity, Childhood obesity treatment, Adolescent obesity, Childhood Obesity Prevention, Family, Community, Physical activity, Nutrition, Hispanic, Latino, Motivational Interviewing, Food Insecurity
Medical subject headings: Pediatric Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The Healthy Living Program/La Vida SaludableBehavioural
Also called HeLP
A whole-family group childhood obesity intervention delivered at community recreation centers
Recommended Treatment of Obesity in Primary CareBehavioural
Also called RTOP
A healthy lifestyle counseling protocol that enhances usual primary care

Study groups in NCT05041855
Study group	Role	What they receive
Community based childhood obesity intervention	Experimental	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. Receives: Behavioral: The Healthy Living Program/La Vida Saludable
Primary care based childhood obesity intervention	Active comparator	A healthy lifestyle counseling intervention delivered by trained primary care providers and health educators at visits occurring every 3 months. Receives: Behavioral: Recommended Treatment of Obesity in Primary Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Body Mass Index (BMI) %95 in children with obesity (treatment)
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).
Measured: From Baseline to Month 18
Change in Body Mass Index (BMI) %95 in healthy and overweight children (prevention)
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.
Measured: From Baseline to Month 18

Secondary outcomes (34)

Change in Body Mass Index (BMI) %95 in children with obesity (treatment)
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.
Measured: From Baseline to Month 12
Change in Body Mass Index (BMI) %95 in healthy and overweight children (prevention)
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.
Measured: From Baseline to Month 12
Change in nutrition aspects of the home environment as measured by the Comprehensive Home Environment Survey (CHES)
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.
Measured: Baseline, Month 18
Change in physical activity and media aspects of the home environment as measured by the Comprehensive Home Environment Survey (CHES)
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.
Measured: Baseline, Month 18
Change from Baseline in food insecurity at 18 months as measured by the US Department of Agriculture (USDA) Household Food Security Survey scores
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.
Measured: Baseline, Month 18
Change from baseline in Hunger at 18 months as measured by the Three-Factor Eating Questionnaire for Children and Adolescents
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.
Measured: Baseline, Month 18
Change from baseline in Cognitive Restraint of Eating at 18 months as measured by the Three-Factor Eating Questionnaire for Children and Adolescents
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.
Measured: Baseline, Month 18
Change from baseline in Disinhibition at 18 months as measured by the Three-Factor Eating Questionnaire for Children and Adolescents
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.
Measured: Baseline, Month 18
Change from baseline in physical fitness at 6 months as measured by the Progressive Aerobic Cardiovascular Endurance Run (PACER) Scores
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.
Measured: Baseline, Month 6
Change from baseline in physical fitness at 18 months as measured by the Progressive Aerobic Cardiovascular Endurance Run (PACER) Scores
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.
Measured: Baseline, Month 18
Change from Baseline in Hemoglobin A1c (HbA1c) blood glucose tests at 18 months
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.
Measured: Baseline up to Month 18
Change from Baseline in Alanine Transaminase (ALT) liver enzyme levels tests at 18 months
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.
Measured: Baseline up to Month 18
Change from Baseline in Low Density Lipoprotein (LDL) Cholesterol tests or fasting lipids tests at 18 months
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.
Measured: Baseline up to Month 18
Change from Baseline in Caregiver Waist Circumference (WC) at 12 months
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.
Measured: Baseline, Month 12
Change from Baseline in Caregiver Waist Circumference (WC) at 18 months
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.
Measured: Baseline, Month 18
Change from Baseline in Adult Caregiver Body Mass Index (BMI) at 12 months
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.
Measured: Baseline, Month 12
Change from Baseline in Adult Caregiver Body Mass Index (BMI) at 18 months
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.
Measured: Baseline, Month 18
Change from Baseline to 6 months in levels of Familism as measured by the Pan-Hispanic Familism Scale
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.
Measured: Baseline, Month 6
Change from Baseline in 18 months in levels of Familism as measured by the Pan-Hispanic Familism Scale
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.
Measured: Baseline, Month 18
Change from Baseline in weight-related quality of life at 6 months as measured by the Sizing Me Up child report
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.
Measured: Baseline, Month 6
Change from Baseline in weight-related quality of life at 18 months as measured by the Sizing Me Up child report
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.
Measured: Baseline, Month 18
Change from Baseline in weight-related quality of life at 6 months as measured by the Sizing Them Up Parent report
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.
Measured: Baseline, Month 6
Change from Baseline in weight-related quality of life at 18 months as measured by the Sizing Them Up Parent report
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.
Measured: Baseline, Month 18
Change from Baseline in depressive symptoms in parents at 6 months as measured by the Center of Epidemiological Studies Depression Scale (CES-D)
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.
Measured: Baseline, Month 6
Change from Baseline in depressive symptoms in parents at 18 months as measured by the Center of Epidemiological Studies Depression Scale (CES-D)
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.
Measured: Baseline, Month 18
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)
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.
Measured: Baseline, Month 6
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)
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.
Measured: Baseline, Month 18
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)
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.
Measured: Baseline, Month 6
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)
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.
Measured: Baseline, Month 18
Reach as measured by the proportion of eligible children seen for well-child care that are randomized.
Reach as measured by the proportion of children seen for a well-child check at each clinic that are randomized during the study.
Measured: up to Month 18
Adoption as measured by the proportion of training sessions attended by medical providers
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.
Measured: up to month 48
Primary Care Visit Frequency in the as measured by number of clinic visits for each child
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.
Measured: up to month 36
Change in history of Coronavirus Disease 2019 (COVID-19) diagnosis status in a parent participant
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.
Measured: Baseline, up to month 18
Change in history of COVID-19 diagnosis status in a child participant
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.
Measured: Baseline, up to month 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 202131 May 2026

First posted13 Sep 2021
Study start15 Nov 2021
Primary completion31 May 2026 (estimated)
Study completion31 May 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (89)Papers the sponsor has linked to this study.
Other trials for Pediatric ObesityStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 554 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05041855
Sponsor's protocol ID: 21-3721
Other IDs: 1R01DK130176-01
Status last verified: Mar 2025
First submitted: 3 Sep 2021
Last updated: 30 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kirk S, Zeller M, Claytor R, Santangelo M, Khoury PR, Daniels SR. The relationship of health outcomes to improvement in BMI in children and adolescents. Obes Res. 2005 May;13(5):876-82. doi: 10.1038/oby.2005.101.
PubMed 15919841
Stevens VJ, Glasgow RE, Toobert DJ, Karanja N, Smith KS. Randomized trial of a brief dietary intervention to decrease consumption of fat and increase consumption of fruits and vegetables. Am J Health Promot. 2002 Jan-Feb;16(3):129-34. doi: 10.4278/0890-1171-16.3.129.
PubMed 11802257
Fontaine KR, Redden DT, Wang C, Westfall AO, Allison DB. Years of life lost due to obesity. JAMA. 2003 Jan 8;289(2):187-93. doi: 10.1001/jama.289.2.187.
PubMed 12517229
Finkelstein EA, Khavjou OA, Thompson H, Trogdon JG, Pan L, Sherry B, Dietz W. Obesity and severe obesity forecasts through 2030. Am J Prev Med. 2012 Jun;42(6):563-70. doi: 10.1016/j.amepre.2011.10.026.
PubMed 22608371
Gilbert, K., et al., Using Health IT to bridge clinic and community in the fight against childhood obesity, in American Public Health Association. 2012: San Francisco. p. publication #268558.
Haemer, M., et al. Controlled Trial of Technology Supported Motivational Interviewing for Childhood Obesity. in The Obesity Society. 2013. Atlanta, GA.
Davidson AJ, McCormick EV, Dickinson LM, Haemer MA, Knierim SD, Hambidge SJ. Population-level obesity surveillance: monitoring childhood body mass index z-score in a safety-net system. Acad Pediatr. 2014 Nov-Dec;14(6):632-8. doi: 10.1016/j.acap.2014.06.007. Epub 2014 Oct 30.
PubMed 25439162
Cason-Wilkerson R, Goldberg S, Albright K, Allison M, Haemer M. Factors influencing healthy lifestyle changes: a qualitative look at low-income families engaged in treatment for overweight children. Child Obes. 2015 Apr;11(2):170-6. doi: 10.1089/chi.2014.0147. Epub 2015 Feb 25.
PubMed 25715107
Knierim SD, Rahm AK, Haemer M, Raghunath S, Martin C, Yang A, Clarke C, Hambidge SJ. Latino parents' perceptions of weight terminology used in pediatric weight counseling. Acad Pediatr. 2015 Mar-Apr;15(2):210-7. doi: 10.1016/j.acap.2014.11.003. Epub 2014 Dec 20.
PubMed 25536907
Haemer, M., et al., Beyond 5210: Results of Universal Lifestyle Screening in Community Health Centers, in Pediatric Academic Societies. 2016: Baltimore, MD.
Cardel MI, Tong S, Pavela G, Dhurandhar E, Miller D, Boles R, Haemer M. Youth Subjective Social Status (SSS) is Associated with Parent SSS, Income, and Food Insecurity but not Weight Loss Among Low-Income Hispanic Youth. Obesity (Silver Spring). 2018 Dec;26(12):1923-1930. doi: 10.1002/oby.22314. Epub 2018 Nov 13.
PubMed 30421861
Haemer, M., et al., Mixed Methods Study of Motivational Interviewing Training on Providers' Counseling for Healthy Weight, in Pediatric Academic Societies. 2018: Toronto, Ontario.
Knierim SD, Newcomer S, Castillo A, Rahm AK, Raghunath S, Clarke C, Wright L, Haemer M, Hambidge SJ. Latino Parents' Perceptions of Pediatric Weight Counseling Terms. Acad Pediatr. 2018 Apr;18(3):342-353. doi: 10.1016/j.acap.2017.09.006. Epub 2017 Sep 12.
PubMed 28919572
Nederveld A, Cox-Martin M, Bayliss E, Allison M, Haemer M. Food Insecurity and Healthy Behavior Counseling in Primary Care. J Health Dispar Res Pract. 2018 Fall;11(3):49-58.
PubMed 34295574
Moore, J., et al., Weight-Related Quality of Life in a Community-Based Weight Management Trial among Underserved Youth, in The Obesity Society. 2019: Las Vegas, NV.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Family Inclusive Childhood Obesity Treatment Designed for Low Income and Hispanic Families
ClinicalTrials.gov ID: NCT05041855
Acronym / sponsor ID: 21-3721
Conditions: Pediatric Obesity, Healthy Eating, Physical Activity, Minority Health, Mindfulness, Family
Keywords: Childhood Obesity, Childhood obesity treatment, Adolescent obesity, Childhood Obesity Prevention, Family, Community, Physical activity, Nutrition
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 554 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Collaborators: Colorado State University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 15 Nov 2021 (actual)
Primary completion: 31 May 2026 (estimated)
Study completion: 31 May 2026 (estimated)
First posted: 13 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Community based childhood obesity intervention	Experimental	Behavioral: The Healthy Living Program/La Vida SaludableA 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.
Primary care based childhood obesity intervention	Active comparator	Behavioral: Recommended Treatment of Obesity in Primary CareA healthy lifestyle counseling intervention delivered by trained primary care providers and health educators at visits occurring every 3 months.

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Child aged 2-16yrs
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.)

Key exclusion criteria (9 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
The Healthy Living Program/La Vida SaludableAlso: HeLPA whole-family group childhood obesity intervention delivered at community recreation centers	Behavioural	Community based childhood obesity intervention
Recommended Treatment of Obesity in Primary CareAlso: RTOPA healthy lifestyle counseling protocol that enhances usual primary care	Behavioural	Primary care based childhood obesity intervention

Primary outcome

Change in Body Mass Index (BMI) %95 in children with obesity (treatment)
Time frame: 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)
Time frame: 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.

34 secondary outcomes

Change in Body Mass Index (BMI) %95 in children with obesity (treatment)
Time frame: From Baseline to Month 12
Change in Body Mass Index (BMI) %95 in healthy and overweight children (prevention)
Time frame: From Baseline to Month 12
Change in nutrition aspects of the home environment as measured by the Comprehensive Home Environment Survey (CHES)
Time frame: Baseline, Month 18
Change in physical activity and media aspects of the home environment as measured by the Comprehensive Home Environment Survey (CHES)
Time frame: Baseline, Month 18
Change from Baseline in food insecurity at 18 months as measured by the US Department of Agriculture (USDA) Household Food Security Survey scores
Time frame: Baseline, Month 18
Change from baseline in Hunger at 18 months as measured by the Three-Factor Eating Questionnaire for Children and Adolescents
Time frame: Baseline, Month 18
Change from baseline in Cognitive Restraint of Eating at 18 months as measured by the Three-Factor Eating Questionnaire for Children and Adolescents
Time frame: Baseline, Month 18
Change from baseline in Disinhibition at 18 months as measured by the Three-Factor Eating Questionnaire for Children and Adolescents
Time frame: Baseline, Month 18
Change from baseline in physical fitness at 6 months as measured by the Progressive Aerobic Cardiovascular Endurance Run (PACER) Scores
Time frame: Baseline, Month 6
Change from baseline in physical fitness at 18 months as measured by the Progressive Aerobic Cardiovascular Endurance Run (PACER) Scores
Time frame: Baseline, Month 18
Change from Baseline in Hemoglobin A1c (HbA1c) blood glucose tests at 18 months
Time frame: Baseline up to Month 18
Change from Baseline in Alanine Transaminase (ALT) liver enzyme levels tests at 18 months
Time frame: Baseline up to Month 18
Change from Baseline in Low Density Lipoprotein (LDL) Cholesterol tests or fasting lipids tests at 18 months
Time frame: Baseline up to Month 18
Change from Baseline in Caregiver Waist Circumference (WC) at 12 months
Time frame: Baseline, Month 12
Change from Baseline in Caregiver Waist Circumference (WC) at 18 months
Time frame: Baseline, Month 18
Change from Baseline in Adult Caregiver Body Mass Index (BMI) at 12 months
Time frame: Baseline, Month 12
Change from Baseline in Adult Caregiver Body Mass Index (BMI) at 18 months
Time frame: Baseline, Month 18
Change from Baseline to 6 months in levels of Familism as measured by the Pan-Hispanic Familism Scale
Time frame: Baseline, Month 6
Change from Baseline in 18 months in levels of Familism as measured by the Pan-Hispanic Familism Scale
Time frame: Baseline, Month 18
Change from Baseline in weight-related quality of life at 6 months as measured by the Sizing Me Up child report
Time frame: Baseline, Month 6
Change from Baseline in weight-related quality of life at 18 months as measured by the Sizing Me Up child report
Time frame: Baseline, Month 18
Change from Baseline in weight-related quality of life at 6 months as measured by the Sizing Them Up Parent report
Time frame: Baseline, Month 6
Change from Baseline in weight-related quality of life at 18 months as measured by the Sizing Them Up Parent report
Time frame: Baseline, Month 18
Change from Baseline in depressive symptoms in parents at 6 months as measured by the Center of Epidemiological Studies Depression Scale (CES-D)
Time frame: Baseline, Month 6
Change from Baseline in depressive symptoms in parents at 18 months as measured by the Center of Epidemiological Studies Depression Scale (CES-D)
Time frame: Baseline, Month 18
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)
Time frame: Baseline, Month 6
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)
Time frame: Baseline, Month 18
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)
Time frame: Baseline, Month 6
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)
Time frame: Baseline, Month 18
Reach as measured by the proportion of eligible children seen for well-child care that are randomized.
Time frame: up to Month 18
Adoption as measured by the proportion of training sessions attended by medical providers
Time frame: up to month 48
Primary Care Visit Frequency in the as measured by number of clinic visits for each child
Time frame: up to month 36
Change in history of Coronavirus Disease 2019 (COVID-19) diagnosis status in a parent participant
Time frame: Baseline, up to month 18
Change in history of COVID-19 diagnosis status in a child participant
Time frame: Baseline, up to month 18

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
Background: PubMed 15919841Kirk S, Zeller M, Claytor R, Santangelo M, Khoury PR, Daniels SR. The relationship of health outcomes to improvement in BMI in children and adolescents. Obes Res. 2005 May;13(5):876-82. doi: 10.1038/oby.2005.101.
Background: PubMed 11802257Stevens VJ, Glasgow RE, Toobert DJ, Karanja N, Smith KS. Randomized trial of a brief dietary intervention to decrease consumption of fat and increase consumption of fruits and vegetables. Am J Health Promot. 2002 Jan-Feb;16(3):129-34. doi: 10.4278/0890-1171-16.3.129.
Background: PubMed 12517229Fontaine KR, Redden DT, Wang C, Westfall AO, Allison DB. Years of life lost due to obesity. JAMA. 2003 Jan 8;289(2):187-93. doi: 10.1001/jama.289.2.187.
Background: PubMed 22608371Finkelstein EA, Khavjou OA, Thompson H, Trogdon JG, Pan L, Sherry B, Dietz W. Obesity and severe obesity forecasts through 2030. Am J Prev Med. 2012 Jun;42(6):563-70. doi: 10.1016/j.amepre.2011.10.026.
BackgroundGilbert, K., et al., Using Health IT to bridge clinic and community in the fight against childhood obesity, in American Public Health Association. 2012: San Francisco. p. publication #268558.
BackgroundHaemer, M., et al. Controlled Trial of Technology Supported Motivational Interviewing for Childhood Obesity. in The Obesity Society. 2013. Atlanta, GA.
Background: PubMed 25439162Davidson AJ, McCormick EV, Dickinson LM, Haemer MA, Knierim SD, Hambidge SJ. Population-level obesity surveillance: monitoring childhood body mass index z-score in a safety-net system. Acad Pediatr. 2014 Nov-Dec;14(6):632-8. doi: 10.1016/j.acap.2014.06.007. Epub 2014 Oct 30.
Background: PubMed 25715107Cason-Wilkerson R, Goldberg S, Albright K, Allison M, Haemer M. Factors influencing healthy lifestyle changes: a qualitative look at low-income families engaged in treatment for overweight children. Child Obes. 2015 Apr;11(2):170-6. doi: 10.1089/chi.2014.0147. Epub 2015 Feb 25.
Background: PubMed 25536907Knierim SD, Rahm AK, Haemer M, Raghunath S, Martin C, Yang A, Clarke C, Hambidge SJ. Latino parents' perceptions of weight terminology used in pediatric weight counseling. Acad Pediatr. 2015 Mar-Apr;15(2):210-7. doi: 10.1016/j.acap.2014.11.003. Epub 2014 Dec 20.
BackgroundHaemer, M., et al., Beyond 5210: Results of Universal Lifestyle Screening in Community Health Centers, in Pediatric Academic Societies. 2016: Baltimore, MD.
Background: PubMed 30421861Cardel MI, Tong S, Pavela G, Dhurandhar E, Miller D, Boles R, Haemer M. Youth Subjective Social Status (SSS) is Associated with Parent SSS, Income, and Food Insecurity but not Weight Loss Among Low-Income Hispanic Youth. Obesity (Silver Spring). 2018 Dec;26(12):1923-1930. doi: 10.1002/oby.22314. Epub 2018 Nov 13.
BackgroundHaemer, M., et al., Mixed Methods Study of Motivational Interviewing Training on Providers' Counseling for Healthy Weight, in Pediatric Academic Societies. 2018: Toronto, Ontario.
Evidence Synthesis, No. 150: Screening for Obesity and Interventions for Weight Management in Children and Adolescents: A Systematic Evidence Review for the U.S. Preventive Services Task Force : Agency for Healthcare Research and Quality (US)Link provided by the sponsor.
USDA. Food Security in the U.S. - Survey Tools.Link provided by the sponsor.
FITNESSGRAM by GreenLight FitnessLink provided by the sponsor.
Pew Research Center - Hispanic Trends. Demographic and Economic Profiles of Hispanics by State and County, 2014. 2020Link provided by the sponsor.
Share\_our\_Strength. Cooking Matters Hands-On Cooking Courses. \[web page\] 2019Link provided by the sponsor.
US\_Census\_Bureau. Detailed Languages Spoken at Home and Ability to Speak English for the Population 5 Years and Over: 2009-2013. 2015 Oct 28, 2015Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Matthew A Haemer, MD MPH principal investigator

University of Colorado, Denver

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Mass Index (BMI) %95 in children with obesity (treatment) (time frame: From Baseline to Month 18). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05041855, which also lists 89 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.