Childhood Obesity Treatment Designed for Low Income and Hispanic Families
NCT ID: NCT05041855
Last Updated: 2025-03-30
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
554 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-11-15
Study Completion Date
2026-05-31
Brief Summary
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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.
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Detailed Description
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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.
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
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Pediatric Obesity
Healthy Eating
Physical Activity
Minority Health
Mindfulness
Family
Counseling
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
The Healthy Living Program/La Vida Saludable
Intervention Type
BEHAVIORAL
A whole-family group childhood obesity intervention delivered at community recreation centers
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.
Group Type
ACTIVE_COMPARATOR
Recommended Treatment of Obesity in Primary Care
Intervention Type
BEHAVIORAL
A healthy lifestyle counseling protocol that enhances usual primary care
Interventions
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The Healthy Living Program/La Vida Saludable
A whole-family group childhood obesity intervention delivered at community recreation centers
Intervention Type
BEHAVIORAL
Recommended Treatment of Obesity in Primary Care
A healthy lifestyle counseling protocol that enhances usual primary care
Intervention Type
BEHAVIORAL
Other Intervention Names
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HeLP
RTOP
Eligibility Criteria
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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.)
* 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.
* 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.
Minimum Eligible Age
2 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Colorado State University
OTHER
Sponsor Role
collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Sponsor Role
collaborator
University of Colorado, Denver
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Matthew A Haemer, MD MPH
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Anschutz
Aurora, Colorado, United States
Site Status
Colorado State University-College of Health and Human Sciences
Fort Collins, Colorado, United States
Site Status
Countries
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United States
References
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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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Haemer, M., et al. Controlled Trial of Technology Supported Motivational Interviewing for Childhood Obesity. in The Obesity Society. 2013. Atlanta, GA.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Haemer, M., et al., Beyond 5210: Results of Universal Lifestyle Screening in Community Health Centers, in Pediatric Academic Societies. 2016: Baltimore, MD.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Haemer, M., et al., Mixed Methods Study of Motivational Interviewing Training on Providers' Counseling for Healthy Weight, in Pediatric Academic Societies. 2018: Toronto, Ontario.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Steen, E., et al. Communication Characteristics of Parents of Latino Preschoolers that Predict Improved Readiness to Change for Child Weight After a Clinic Visit. in American Society for Nutrition. 2020. Seattle WA.
Reference Type
BACKGROUND
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
Reference Type
BACKGROUND
Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.
Reference Type
BACKGROUND
Spear BA, Barlow SE, Ervin C, Ludwig DS, Saelens BE, Schetzina KE, Taveras EM. Recommendations for treatment of child and adolescent overweight and obesity. Pediatrics. 2007 Dec;120 Suppl 4:S254-88. doi: 10.1542/peds.2007-2329F.
Reference Type
BACKGROUND
Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.
Reference Type
BACKGROUND
Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA. RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health. 2019 Mar 29;7:64. doi: 10.3389/fpubh.2019.00064. eCollection 2019.
Reference Type
BACKGROUND
Shomaker LB, Pivarunas B, Annameier SK, Gulley L, Quaglia J, Brown KW, Broderick P, Bell C. One-Year Follow-Up of a Randomized Controlled Trial Piloting a Mindfulness-Based Group Intervention for Adolescent Insulin Resistance. Front Psychol. 2019 May 8;10:1040. doi: 10.3389/fpsyg.2019.01040. eCollection 2019.
Reference Type
BACKGROUND
Pinard CA, Yaroch AL, Hart MH, Serrano EL, McFerren MM, Estabrooks PA. The Validity and reliability of the Comprehensive Home Environment Survey (CHES). Health Promot Pract. 2014 Jan;15(1):109-17. doi: 10.1177/1524839913477863. Epub 2013 Mar 7.
Reference Type
BACKGROUND
Resnicow K, McMaster F, Woolford S, Slora E, Bocian A, Harris D, Drehmer J, Wasserman R, Schwartz R, Myers E, Foster J, Snetselaar L, Hollinger D, Smith K. Study design and baseline description of the BMI2 trial: reducing paediatric obesity in primary care practices. Pediatr Obes. 2012 Feb;7(1):3-15. doi: 10.1111/j.2047-6310.2011.00001.x. Epub 2011 Dec 13.
Reference Type
BACKGROUND
Schwartz RP, Hamre R, Dietz WH, Wasserman RC, Slora EJ, Myers EF, Sullivan S, Rockett H, Thoma KA, Dumitru G, Resnicow KA. Office-based motivational interviewing to prevent childhood obesity: a feasibility study. Arch Pediatr Adolesc Med. 2007 May;161(5):495-501. doi: 10.1001/archpedi.161.5.495.
Reference Type
BACKGROUND
Resnicow K, Harris D, Wasserman R, Schwartz RP, Perez-Rosas V, Mihalcea R, Snetselaar L. Advances in Motivational Interviewing for Pediatric Obesity: Results of the Brief Motivational Interviewing to Reduce Body Mass Index Trial and Future Directions. Pediatr Clin North Am. 2016 Jun;63(3):539-62. doi: 10.1016/j.pcl.2016.02.008.
Reference Type
BACKGROUND
Resnicow K, McMaster F, Bocian A, Harris D, Zhou Y, Snetselaar L, Schwartz R, Myers E, Gotlieb J, Foster J, Hollinger D, Smith K, Woolford S, Mueller D, Wasserman RC. Motivational interviewing and dietary counseling for obesity in primary care: an RCT. Pediatrics. 2015 Apr;135(4):649-57. doi: 10.1542/peds.2014-1880.
Reference Type
BACKGROUND
Klein JD, Sesselberg TS, Johnson MS, O'Connor KG, Cook S, Coon M, Homer C, Krebs N, Washington R. Adoption of body mass index guidelines for screening and counseling in pediatric practice. Pediatrics. 2010 Feb;125(2):265-72. doi: 10.1542/peds.2008-2985. Epub 2010 Jan 18.
Reference Type
BACKGROUND
Runkle C, Osterholm A, Hoban R, McAdam E, Tull R. Brief negotiation program for promoting behavior change: the Kaiser Permanente approach to continuing professional development. Educ Health (Abingdon). 2000;13(3):377-86. doi: 10.1080/135762800750059499.
Reference Type
BACKGROUND
Lozano P, McPhillips HA, Hartzler B, Robertson AS, Runkle C, Scholz KA, Stout JW, Kieckhefer GM. Randomized trial of teaching brief motivational interviewing to pediatric trainees to promote healthy behaviors in families. Arch Pediatr Adolesc Med. 2010 Jun;164(6):561-6. doi: 10.1001/archpediatrics.2010.86.
Reference Type
BACKGROUND
Arora S, Kalishman SG, Thornton KA, Komaromy MS, Katzman JG, Struminger BB, Rayburn WF, Bradford AM. Project ECHO: A Telementoring Network Model for Continuing Professional Development. J Contin Educ Health Prof. 2017 Fall;37(4):239-244. doi: 10.1097/CEH.0000000000000172.
Reference Type
BACKGROUND
Freedman DS, Butte NF, Taveras EM, Lundeen EA, Blanck HM, Goodman AB, Ogden CL. BMI z-Scores are a poor indicator of adiposity among 2- to 19-year-olds with very high BMIs, NHANES 1999-2000 to 2013-2014. Obesity (Silver Spring). 2017 Apr;25(4):739-746. doi: 10.1002/oby.21782. Epub 2017 Feb 28.
Reference Type
BACKGROUND
Freedman DS, Butte NF, Taveras EM, Goodman AB, Ogden CL, Blanck HM. The Limitations of Transforming Very High Body Mass Indexes into z-Scores among 8.7 Million 2- to 4-Year-Old Children. J Pediatr. 2017 Sep;188:50-56.e1. doi: 10.1016/j.jpeds.2017.03.039. Epub 2017 Apr 19.
Reference Type
BACKGROUND
Freedman DS, Butte NF, Taveras EM, Goodman AB, Blanck HM. Longitudinal changes in BMI z-scores among 45 414 2-4-year olds with severe obesity. Ann Hum Biol. 2017 Dec;44(8):687-692. doi: 10.1080/03014460.2017.1388845. Epub 2017 Oct 30.
Reference Type
BACKGROUND
Freedman DS, Berenson GS. Tracking of BMI z Scores for Severe Obesity. Pediatrics. 2017 Sep;140(3):e20171072. doi: 10.1542/peds.2017-1072. Epub 2017 Aug 22.
Reference Type
BACKGROUND
Gattshall ML, Shoup JA, Marshall JA, Crane LA, Estabrooks PA. Validation of a survey instrument to assess home environments for physical activity and healthy eating in overweight children. Int J Behav Nutr Phys Act. 2008 Jan 11;5:3. doi: 10.1186/1479-5868-5-3.
Reference Type
BACKGROUND
Martin-Garcia M, Vila-Maldonado S, Rodriguez-Gomez I, Faya FM, Plaza-Carmona M, Pastor-Vicedo JC, Ara I. The Spanish version of the Three Factor Eating Questionnaire-R21 for children and adolescents (TFEQ-R21C): Psychometric analysis and relationships with body composition and fitness variables. Physiol Behav. 2016 Oct 15;165:350-7. doi: 10.1016/j.physbeh.2016.08.015. Epub 2016 Aug 15.
Reference Type
BACKGROUND
Cappelleri JC, Bushmakin AG, Gerber RA, Leidy NK, Sexton CC, Lowe MR, Karlsson J. Psychometric analysis of the Three-Factor Eating Questionnaire-R21: results from a large diverse sample of obese and non-obese participants. Int J Obes (Lond). 2009 Jun;33(6):611-20. doi: 10.1038/ijo.2009.74. Epub 2009 Apr 28.
Reference Type
BACKGROUND
Scott SN, Springer CM, Oody JF, McClanahan MS, Wiseman BD, Kybartas TJ, Coe DP. Development and Validation of a PACER Prediction Equation for VO2peak in 10- to 15-Year-Old Youth. Pediatr Exerc Sci. 2019 May 1;31(2):223-228. doi: 10.1123/pes.2018-0136. Epub 2019 Jan 3.
Reference Type
BACKGROUND
Welk, G.J. and M.D. Meredith, eds. Fitnessgram / Activitygram Reference Guide. 2008, The Cooper Institute.: Dallas, TX.
Reference Type
BACKGROUND
Blumberg SJ, Bialostosky K, Hamilton WL, Briefel RR. The effectiveness of a short form of the Household Food Security Scale. Am J Public Health. 1999 Aug;89(8):1231-4. doi: 10.2105/ajph.89.8.1231.
Reference Type
BACKGROUND
Mills SD, Malcarne VL, Fox RS, Sadler GR. Psychometric Evaluation of the Brief Acculturation Scale for Hispanics. Hisp J Behav Sci. 2014 May 1;36(2):164-174. doi: 10.1177/0739986314526697.
Reference Type
BACKGROUND
Villarreal, R., S. Blozis, and K. Widaman, Factorial Invariance of a Pan-Hispanic Familism Scale. Hispanic Journal of Behavioral Sciences, 2005. 27: p. 409 - 425.
Reference Type
BACKGROUND
Knight GP, Gonzales NA, Saenz DS, Bonds DD, German M, Deardorff J, Roosa MW, Updegraff KA. The Mexican American Cultural Values scales for Adolescents and Adults. J Early Adolesc. 2010 Jun;30(3):444-481. doi: 10.1177/0272431609338178.
Reference Type
BACKGROUND
Zeller MH, Modi AC. Development and initial validation of an obesity-specific quality-of-life measure for children: sizing me up. Obesity (Silver Spring). 2009 Jun;17(6):1171-7. doi: 10.1038/oby.2009.47. Epub 2009 Mar 5.
Reference Type
BACKGROUND
Prescott CA, McArdle JJ, Hishinuma ES, Johnson RC, Miyamoto RH, Andrade NN, Edman JL, Makini GK Jr, Nahulu LB, Yuen NY, Carlton BS. Prediction of major depression and dysthymia from CES-D scores among ethnic minority adolescents. J Am Acad Child Adolesc Psychiatry. 1998 May;37(5):495-503. doi: 10.1097/00004583-199805000-00012.
Reference Type
BACKGROUND
Soler J, Perez-Sola V, Puigdemont D, Perez-Blanco J, Figueres M, Alvarez E. [Validation study of the Center for Epidemiological Studies-Depression of a Spanish population of patients with affective disorders]. Actas Luso Esp Neurol Psiquiatr Cienc Afines. 1997 Jul-Aug;25(4):243-9. Spanish.
Reference Type
BACKGROUND
Garrison CZ, Addy CL, Jackson KL, McKeown RE, Waller JL. The CES-D as a screen for depression and other psychiatric disorders in adolescents. J Am Acad Child Adolesc Psychiatry. 1991 Jul;30(4):636-41. doi: 10.1097/00004583-199107000-00017.
Reference Type
BACKGROUND
Faulstich ME, Carey MP, Ruggiero L, Enyart P, Gresham F. Assessment of depression in childhood and adolescence: an evaluation of the Center for Epidemiological Studies Depression Scale for Children (CES-DC). Am J Psychiatry. 1986 Aug;143(8):1024-7. doi: 10.1176/ajp.143.8.1024.
Reference Type
BACKGROUND
Moyers TB, Rowell LN, Manuel JK, Ernst D, Houck JM. The Motivational Interviewing Treatment Integrity Code (MITI 4): Rationale, Preliminary Reliability and Validity. J Subst Abuse Treat. 2016 Jun;65:36-42. doi: 10.1016/j.jsat.2016.01.001. Epub 2016 Jan 13.
Reference Type
BACKGROUND
Rabin BA, McCreight M, Battaglia C, Ayele R, Burke RE, Hess PL, Frank JW, Glasgow RE. Systematic, Multimethod Assessment of Adaptations Across Four Diverse Health Systems Interventions. Front Public Health. 2018 Apr 9;6:102. doi: 10.3389/fpubh.2018.00102. eCollection 2018.
Reference Type
BACKGROUND
Ritzwoller DP, Sukhanova A, Gaglio B, Glasgow RE. Costing behavioral interventions: a practical guide to enhance translation. Ann Behav Med. 2009 Apr;37(2):218-27. doi: 10.1007/s12160-009-9088-5. Epub 2009 Mar 17.
Reference Type
BACKGROUND
Cidav Z, Mandell D, Pyne J, Beidas R, Curran G, Marcus S. A pragmatic method for costing implementation strategies using time-driven activity-based costing. Implement Sci. 2020 May 5;15(1):28. doi: 10.1186/s13012-020-00993-1.
Reference Type
BACKGROUND
Mauricio AM, Tein JY, Gonzales NA, Millsap RE, Dumka LE. Attendance Patterns and Links to Non-Response on Child Report of Internalizing among Mexican-Americans Randomized to a Universal Preventive Intervention. Prev Sci. 2018 Feb;19(Suppl 1):27-37. doi: 10.1007/s11121-016-0632-9.
Reference Type
BACKGROUND
Turer CB, Stroo M, Brouwer RJ, Krause KM, Lovelady CA, Bastian LA, Peterson B, Ostbye T. Do high-risk preschoolers or overweight mothers meet AAP-recommended behavioral goals for reducing obesity? Acad Pediatr. 2013 May-Jun;13(3):243-50. doi: 10.1016/j.acap.2013.01.003. Epub 2013 Jan 9.
Reference Type
BACKGROUND
Rich SS, DiMarco NM, Huettig C, Essery EV, Andersson E, Sanborn CF. Perceptions of health status and play activities in parents of overweight Hispanic toddlers and preschoolers. Fam Community Health. 2005 Apr-Jun;28(2):130-41. doi: 10.1097/00003727-200504000-00005.
Reference Type
BACKGROUND
Hernandez RG, Cheng TL, Serwint JR. Parents' healthy weight perceptions and preferences regarding obesity counseling in preschoolers: pediatricians matter. Clin Pediatr (Phila). 2010 Aug;49(8):790-8. doi: 10.1177/0009922810368288. Epub 2010 Jun 3.
Reference Type
BACKGROUND
Gauthier KI, Gance-Cleveland B. Hispanic parents' perceptions of their preschool children's weight status. J Spec Pediatr Nurs. 2016 Apr;21(2):84-93. doi: 10.1111/jspn.12143. Epub 2016 Apr 15.
Reference Type
BACKGROUND
McGavock J, Chauhan BF, Rabbani R, Dias S, Klaprat N, Boissoneault S, Lys J, Wierzbowski AK, Sakib MN, Zarychanski R, Abou-Setta AM. Layperson-Led vs Professional-Led Behavioral Interventions for Weight Loss in Pediatric Obesity: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Jul 1;3(7):e2010364. doi: 10.1001/jamanetworkopen.2020.10364.
Reference Type
BACKGROUND
Bleich SN, Segal J, Wu Y, Wilson R, Wang Y. Systematic review of community-based childhood obesity prevention studies. Pediatrics. 2013 Jul;132(1):e201-10. doi: 10.1542/peds.2013-0886. Epub 2013 Jun 10.
Reference Type
BACKGROUND
Haemer, M., Why Does Cooking Matter? Outcomes of Nutrition Education in Collaboration with Health Care, in Share Our Strength's National Convening. 2015: Washington DC.
Reference Type
BACKGROUND
Li PP, Mackey G, Callender C, Dave JM, Olvera N, Alford S, Thompson D. Culinary Education Programs for Children in Low-Income Households: A Scoping Review. Children (Basel). 2020 May 13;7(5):47. doi: 10.3390/children7050047.
Reference Type
BACKGROUND
Hasan B, Thompson WG, Almasri J, Wang Z, Lakis S, Prokop LJ, Hensrud DD, Frie KS, Wirtz MJ, Murad AL, Ewoldt JS, Murad MH. The effect of culinary interventions (cooking classes) on dietary intake and behavioral change: a systematic review and evidence map. BMC Nutr. 2019 May 10;5:29. doi: 10.1186/s40795-019-0293-8. eCollection 2019.
Reference Type
BACKGROUND
Overcash F, Ritter A, Mann T, Mykerezi E, Redden J, Rendahl A, Vickers Z, Reicks M. Impacts of a Vegetable Cooking Skills Program Among Low-Income Parents and Children. J Nutr Educ Behav. 2018 Sep;50(8):795-802. doi: 10.1016/j.jneb.2017.10.016. Epub 2017 Dec 12.
Reference Type
BACKGROUND
Liu GC, Hannon T, Qi R, Downs SM, Marrero DG. The obesity epidemic in children: Latino children are disproportionately affected at younger ages. Int J Pediatr Adolesc Med. 2015 Mar;2(1):12-18. doi: 10.1016/j.ijpam.2015.03.004. Epub 2015 Apr 4.
Reference Type
BACKGROUND
Lee H, Hicken MT. Cumulative social risk and racial/ethnic disparities in obesity during the transition to adulthood. J Health Care Poor Underserved. 2013 May;24(2):907-27. doi: 10.1353/hpu.2013.0090.
Reference Type
BACKGROUND
Dabelea D, Mayer-Davis EJ, Saydah S, Imperatore G, Linder B, Divers J, Bell R, Badaru A, Talton JW, Crume T, Liese AD, Merchant AT, Lawrence JM, Reynolds K, Dolan L, Liu LL, Hamman RF; SEARCH for Diabetes in Youth Study. Prevalence of type 1 and type 2 diabetes among children and adolescents from 2001 to 2009. JAMA. 2014 May 7;311(17):1778-86. doi: 10.1001/jama.2014.3201.
Reference Type
BACKGROUND
Maskarinec G, Grandinetti A, Matsuura G, Sharma S, Mau M, Henderson BE, Kolonel LN. Diabetes prevalence and body mass index differ by ethnicity: the Multiethnic Cohort. Ethn Dis. 2009 Winter;19(1):49-55.
Reference Type
BACKGROUND
Aguayo-Mazzucato C, Diaque P, Hernandez S, Rosas S, Kostic A, Caballero AE. Understanding the growing epidemic of type 2 diabetes in the Hispanic population living in the United States. Diabetes Metab Res Rev. 2019 Feb;35(2):e3097. doi: 10.1002/dmrr.3097. Epub 2018 Dec 4.
Reference Type
BACKGROUND
O'Connor EA, Evans CV, Burda BU, Walsh ES, Eder M, Lozano P. Screening for Obesity and Intervention for Weight Management in Children and Adolescents: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2017 Jun 20;317(23):2427-2444. doi: 10.1001/jama.2017.0332.
Reference Type
BACKGROUND
Weaver RG, Brazendale K, Hunt E, Sarzynski MA, Beets MW, White K. Disparities in childhood overweight and obesity by income in the United States: an epidemiological examination using three nationally representative datasets. Int J Obes (Lond). 2019 Jun;43(6):1210-1222. doi: 10.1038/s41366-019-0331-2. Epub 2019 Feb 4.
Reference Type
BACKGROUND
Kelly ML, Ackerman PD, Ross LF. The participation of minorities in published pediatric research. J Natl Med Assoc. 2005 Jun;97(6):777-83.
Reference Type
BACKGROUND
Love-Osborne K, Fortune R, Sheeder J, Federico S, Haemer MA. School-based health center-based treatment for obese adolescents: feasibility and body mass index effects. Child Obes. 2014 Oct;10(5):424-31. doi: 10.1089/chi.2013.0165. Epub 2014 Sep 26.
Reference Type
BACKGROUND
Fagg J, Chadwick P, Cole TJ, Cummins S, Goldstein H, Lewis H, Morris S, Radley D, Sacher P, Law C. From trial to population: a study of a family-based community intervention for childhood overweight implemented at scale. Int J Obes (Lond). 2014 Oct;38(10):1343-9. doi: 10.1038/ijo.2014.103. Epub 2014 Jun 12.
Reference Type
BACKGROUND
Sacher PM, Kolotourou M, Chadwick PM, Cole TJ, Lawson MS, Lucas A, Singhal A. Randomized controlled trial of the MEND program: a family-based community intervention for childhood obesity. Obesity (Silver Spring). 2010 Feb;18 Suppl 1:S62-8. doi: 10.1038/oby.2009.433.
Reference Type
BACKGROUND
Hoelscher DM, Butte NF, Barlow S, Vandewater EA, Sharma SV, Huang T, Finkelstein E, Pont S, Sacher P, Byrd-Williams C, Oluyomi AO, Durand C, Li L, Kelder SH. Incorporating primary and secondary prevention approaches to address childhood obesity prevention and treatment in a low-income, ethnically diverse population: study design and demographic data from the Texas Childhood Obesity Research Demonstration (TX CORD) study. Child Obes. 2015 Feb;11(1):71-91. doi: 10.1089/chi.2014.0084. Epub 2015 Jan 2.
Reference Type
BACKGROUND
Butte NF, Hoelscher DM, Barlow SE, Pont S, Durand C, Vandewater EA, Liu Y, Adolph AL, Perez A, Wilson TA, Gonzalez A, Puyau MR, Sharma SV, Byrd-Williams C, Oluyomi A, Huang T, Finkelstein EA, Sacher PM, Kelder SH. Efficacy of a Community- Versus Primary Care-Centered Program for Childhood Obesity: TX CORD RCT. Obesity (Silver Spring). 2017 Sep;25(9):1584-1593. doi: 10.1002/oby.21929. Epub 2017 Jul 13.
Reference Type
BACKGROUND
Chambers DA. Sharpening our focus on designing for dissemination: Lessons from the SPRINT program and potential next steps for the field. Transl Behav Med. 2020 Dec 31;10(6):1416-1418. doi: 10.1093/tbm/ibz102.
Reference Type
BACKGROUND
Hollingworth W, Hawkins J, Lawlor DA, Brown M, Marsh T, Kipping RR. Economic evaluation of lifestyle interventions to treat overweight or obesity in children. Int J Obes (Lond). 2012 Apr;36(4):559-66. doi: 10.1038/ijo.2011.272. Epub 2012 Jan 17.
Reference Type
BACKGROUND
Polgar, J., S. Goldberg, and M. Haemer, An Economic Perspective On a Community-Based Childhood Obesity Treatment Program, in Colorado Public Health Forum. 2016: Aurora, CO
Reference Type
BACKGROUND
Haemer MA, Ranade D, Baron AE, Krebs NF. A clinical model of obesity treatment is more effective in preschoolers and Spanish speaking families. Obesity (Silver Spring). 2013 May;21(5):1004-12. doi: 10.1002/oby.20192.
Reference Type
BACKGROUND
S, A., et al., Boot Camp Translation for the Prevention of Type 2 Diabetes (T2D) in Fort Collins' Hispanic/Latino Adolescents., in CCTSI Community Engagement Conference. 2017
Reference Type
BACKGROUND
Haemer, M., et al., Pilot Results of a Multi-level Partnership to treat Obesity in Low-Income Hispanic Children, in The Obesity Society Annual Meeting. 2011. p. publication # LB-P-50
Reference Type
BACKGROUND
Haemer, M., et al. An Enhanced Screen Performs Better than 5-2-1-0 for Lifestyle Assessment in Low-Income Hispanic Children. in Pediatric Academic Societies. 2012. Boston, MA
Reference Type
BACKGROUND
Haemer, M., et al. One-Year Outcomes from a Controlled Trial of Family-Inclusive Weight Management in Underserved Children. in Pediatric Academic Societies. 2015. San Diego, CA
Reference Type
BACKGROUND
Haemer, M., et al., Food Neophobia in Latino Preschoolers: Correlation with Intake and Pilot Intervention Results, in American Society of Nutrition Annual Meeting at Experimental Biology. 2014: San Diego, CA
Reference Type
BACKGROUND
Belay B, Frintner MP, Liebhart JL, Lindros J, Harrison M, Sisk B, Dooyema CA, Hassink SG, Cook SR. US Pediatrician Practices and Attitudes Concerning Childhood Obesity: 2006 and 2017. J Pediatr. 2019 Aug;211:78-84.e2. doi: 10.1016/j.jpeds.2019.04.030. Epub 2019 May 18.
Reference Type
BACKGROUND
Welk GJ, Meredith MD, Ihmels M, Seeger C. Distribution of health-related physical fitness in Texas youth: a demographic and geographic analysis. Res Q Exerc Sport. 2010 Sep;81(3 Suppl):S6-15. doi: 10.1080/02701367.2010.10599689.
Reference Type
BACKGROUND
Haemer M, Tong S, Bracamontes P, Gritz M, Osborn B, Perez-Jolles M, Shomaker L, Steen E, Studts C, Boles R. Randomized-controlled trial of a whole-family obesity prevention and treatment intervention designed for low-income Hispanic families: HeLP the healthy living program. Contemp Clin Trials. 2023 Dec;135:107359. doi: 10.1016/j.cct.2023.107359. Epub 2023 Oct 16.
Reference Type
DERIVED
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form: Consent-Parents
Document Type: Informed Consent Form: Consent-HeLP Staff
Document Type: Informed Consent Form: Consent-Providers
Related Links
Access external resources that provide additional context or updates about the study.
http://www.ncbi.nlm.nih.gov/books/NBK476325/
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)
https://www.ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-us/survey-tools/
USDA. Food Security in the U.S. - Survey Tools.
https://www.fitnessgram.net/
FITNESSGRAM by GreenLight Fitness
http://www.pewresearch.org/hispanic/states/state/co
Pew Research Center - Hispanic Trends. Demographic and Economic Profiles of Hispanics by State and County, 2014. 2020
http://cookingmatters.org
Share\_our\_Strength. Cooking Matters Hands-On Cooking Courses. \[web page\] 2019
https://www.servsafe.com/ServSafe-Food-Handler/Buy-Handler-Products?gclid=Cj0KCQjwy8f6BRC7ARIsAPIXOjj0S3lIjS62X_ltKs9nyPRBUSZ_RofVDOdJtz3POiNCU0YRcThiIqcaAlcVEALw_wcB
ServSafe. ServSafe - Food Safety Training. 2020 2020
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21-3721
Identifier Type: -
Identifier Source: org_study_id
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