Community Active and Healthy Families: Family-Centered Obesity Treatment for Latino Children
Phase: NA
Conditions: Obesity, Childhood
Sponsor: University of Colorado, Denver

 
 
 
 
 
 
 
Project Title: Community Active and Healthy Families: Family-Centered Obesity 
Treatment for Latino Children 
Protocol Version Date: October 13, 2022 
NCT #: NCT04414553 
 
 

 
 
I. 
HYPOTHESES AND SPECIFIC AIMS:   
 
This Human Subjects Research involves a pilot trial using a pre/post design to simultaneously to evaluate the feasibility, 
acceptability, and preliminary effectiveness of a weight management intervention, Community Active and Healthy Families 
(Community-AHF), at reducing child body mass index (BMI).   
 
 
Study Aim : To pilot Community-AHF among 5–12-year-old overweight and obese Latino children in immigrant families 
(n=40 parent/child dyads) using a pre/post design   
• 
We will examine changes in child BMI (primary outcome) and in diet, physical activity, and parenting skills/stress 
(secondary outcomes) pre- and post-intervention to assess for indicators of intervention effectiveness and to gather the 
information needed to refine measures, and measurement procedures in preparation for a pragmatic randomized 
controlled trial.  
• 
We will evaluate pilot implementation via assessing program acceptability and feasibility. We hypothesize that families 
will report high levels of program acceptability and that implementing community organizations/clinics will report high 
levels of program feasibility and an intention to maintain participation in a future trial. We will also conduct qualitative 
interviews to explore implementation successes and challenges to guide refinement of implementation protocols for a 
future trial. 
 
II. BACKGROUND AND SIGNIFICANCE:  
Effective, family-oriented childhood weight management interventions for Latinos are critical in order to decrease lifetime 
cardiovascular disease (CVD) risk that stems from childhood obesity. Childhood obesity is a risk factor for adult CVD, the 
leading cause of death in the US.1,2 One in four US children is Latino and Latino children have among the highest childhood 
obesity rates of any racial/ethnic group.3-5 US-born Latino children of immigrant parents comprise half of US Latino children 
and experience higher obesity rates than other Latino children.6,7 Obesity rates among Latino children have increased during 
the COVID-19 pandemic.8 In parallel with obesity prevention efforts, a specific focus on treatment is urgently needed. 
 
Implementation of current US Preventive Services Task Force (USPSTF) recommendations for childhood obesity has the 
potential to exacerbate existing disparities for Latino children in immigrant families. The USPSTF recommends referral of 
all children with obesity to an intensive weight management program to prompt behavior changes to decrease body mass 
index (BMI).9 Intensive programs are found mainly in clinical settings, are limited in number and frequently are not feasible 
for Latino immigrant families.10,11 Sustaining participation of Latino immigrant families in intensive community-based 
programs has been difficult due to the time commitment required and cultural and language barriers.12,13 Reducing obesity 
disparities for Latino children in immigrant families requires addressing the current lack of evidence-based obesity treatment 
programs that are tailored to their sociocultural needs and delivered at a feasible intensity.  
 
We propose addressing this gap with the Community-Active and Healthy Families (Community-AHF) intervention. 
Community-AHF is a behavioral-theory based, culturally tailored, Spanish-language weight management program for 
overweight/obese Latino children and their families. Community-AHF has recommended USPSTF components of intensive 
weight management delivered at a feasible intensity for low-income families.9 To create Community-AHF, we engaged 
partners to complete Intervention Mapping to adapt an evidence-based weight management intervention designed for low-
income Latino children in immigrant families delivered in healthcare settings.14-16 Community-AHF retains key components 
of the original intervention and responds to feedback from Latino immigrant families that delivery in a community setting is 
preferable to a clinic due to easier access to and greater trust and familiarity with community organizations.  
 
Intervention delivery in a community setting requires critical attention to how this change in delivery setting may impact 
intervention components and their implementation. We engaged key partners using community-based participatory 
research (CBPR) principles to identify adaptations of Clinic-AHF to allow for community delivery via a systematic process, 
Intervention Mapping-Adapt.15 This process has been used successfully in adapting and implementing health interventions 
among immigrant Latinos in the US.17-19 Use of this process ensures that Community-AHF retains Clinic-AHF essential 
components while incorporating adaptations required of the new delivery setting. While Intervention Mapping-Adapt was 
the appropriate element of Intervention Mapping for adaptation, Implementation Mapping, is the right process to ensure 
“how” the core components of the intervention are delivered meets partners’ needs and priorities.15,20 
 
 
II. 
RESEARCH METHODS 
 
A. OUTCOME MEASURE(S):  
 
 
Change in child body mass index, diet, physical activity, obesogenic food availability in the home, parent physical activity 

 
promotion, parenting self-efficacy, parent perceived stress, intervention acceptability, feasibility, intervention fidelity 
 
B. DESCRIPTION OF POPULATION TO BE ENROLLED:  
 
Community-AHF Pilot enrollment is for six (6) months. For this part of the study, we will be relying on primary care referrals 
or community based referrals. 
• Inclusion Criteria: 1) Child aged 5-12; 2) Child BMI > 85th %tile; and 3) Parent self-identifies as foreign-born 
Latino/Hispanic and speaks Spanish. 
• Exclusion Criteria: Child medical contraindication to diet/PA modification and Child BMI ≥40kg/m2 (obesity this severe 
needs subspecialty management) 
 
C. STUDY DESIGN AND RESEARCH METHODS:  
Study Design: 
We will recruit child-parent dyads from one primary care pediatric practice in both CO and MD or via outreach by our 
community partner in CO. We will recruit 20 child-parent dyads at each site. We will enroll 40 overweight (BMI>85th%ile for 
age and sex) or obese (BMI>95th%ile for age and sex) 5–12-year-old patients and a parent/guardian. We will examine 
changes in the anticipated trial outcomes. We will assess intervention acceptability and feasibility to parents and examine 
preliminary effectiveness. The primary effectiveness outcome will be a change in BMI from baseline to follow up. Secondary 
outcomes reflect key features of the intervention curriculum that promote child and family behavior change including child 
diet and PA, home food environment, parent PA promotion and parenting self-efficacy. We will also conduct a preliminary 
implementation evaluation. If two (2) children in the same household are eligible, one will be randomly selected to be in the 
index child participant. 
 
Community AHF is a 10-month intervention with 20 contact hours (16 in person during the active phase and 4 virtual during 
the maintenance phase). Each index child participant must be accompanied by a parent; additional parents/caregivers and 
siblings of the index child may attend. This pilot will evaluate the active phase of the intervention only given the time 
constraints of this funding mechanism. Effectiveness data for the evidence-based intervention from which Community-AHF 
was adapted is based on the 4-month active phase.14 During the 4-month active phase participants attend eight 2-hour 
semimonthly group education sessions. Sessions follow a curriculum and provide: 1) Practical information to increase 
knowledge and perceived importance of healthy diet and PA practices; 2) Skill building in problem-solving and positive 
parenting to overcome barriers to behavior change at the child and family-level; 3) PA; and 4) Facilitated supportive 
discussion to assist parents in managing stressors and SDOH barriers to healthy weight.  
 
Each session covers specific objectives and includes complementary hands-on activities and breakout groups for children 
(children’s breakouts are often conducted in English). At the conclusion of each session participants receive take-home 
materials to facilitate behavior change. Sessions are co-facilitated by a registered nurse and CHW. Additionally, participants 
complete 7 CHW coaching calls (15-20 minutes) during weeks without a group session to reinforce change goals and 
discuss successes and challenges meeting these goals. During the 6-month maintenance phase which will be employed in 
a future trial, participants will complete monthly, 20-minute coaching calls, attend a primary care obesity follow-up visit, and 
attend a concluding celebration. Community-AHF will be delivered by trusted community organizations well-known to the 
local Latino community and experienced in providing community programming. 
 
We will also complete a qualitative evaluation of the Community-AHF pilot and its implementation. We will interview a subset 
of parents and youth who participate in the intervention for this portion. These interviews will take place after the completion 
of the pilot.  
 
Retention –  
Strategies include: 1) obtaining multiple methods of contact with updates at each point of contact with the study team and 
obtaining permission to extract contact information from the child’s electronic health record; 2) establishing loss to follow-
up protocols using multiple contacts for each method of participant contact; 3) creating a study identity through use of a 
logo and consistent fonts and colors on all study materials; 4) employing bilingual staff skilled at building relationships with 
immigrant study participants; 5) offering remuneration for participation in data collection; and 6) scheduling data collection 
visits based on participant preference including evenings and weekends.  
 
Consent – 
 
Owing to the characteristics of our study population, we expect to utilize Spanish-language consent forms for parents and 
need to account for limited literacy of participants. We will utilize an informed consent process that we have previously 
found effective with the proposed study population. The research staff member will read the Spanish-language form aloud 
while the participant follows along with their own hardcopy, elicit, and respond to participant questions, and finally 
ascertain understanding via 2-3 brief questions (e.g., Will participants in the Community-AHF program complete surveys?) 
Participants will have as much time as necessary to review the consent form and ask questions. 

 
 
We will complete an assent process for children ≥7 years of age participating in the Community-AHF pilot. A research 
staff member will discuss the research with the child in the presence of the child's parent or guardian. The assent process 
will discuss the purpose of the research study, what the participants would have to do in the research study, associated 
risks and benefits and emphasize that the participation is voluntary. We will have the child provide verbal assent, and this 
assent will be noted on the parent's consent form.  
 
Signed consent forms will be kept in a locked file cabinet in a locked office. Participants will be provided with a copy of the 
consent form for their reference. 
 
Additionally, we are requesting a waiver of consent and HIPAA authorization for the screening used to determine eligibility 
for children for the Community-AHF program.  
 
Renumeration –  
  
Participants in the Community-AHF pilot will receive the following remuneration:  
Survey-Baseline ($75) 
Survey-Follow Up (4 months after baseline) ($75) 
Accelerometer-Baseline ($50) 
Accelerometer-Follow Up ($50) 
Follow-up Interview-Parent ($50) and Follow-up Interview-Youth ($25) 
 
 
 
Research Methods: 
Pilot dyads will complete the active phase of the Community-AHF intervention that includes eight (8), semimonthly 2-hour 
group education sessions for 16 weeks, and 8 biweekly coaching calls. Sessions follow a curriculum and provide: 1) 
Practical information to increase knowledge and perceived importance of healthy diet and physical activity practices; 2) Skill 
building in problem-solving and positive parenting to overcome barriers to behavior change at the child and family-level; 3) 
Physical activity; and 4) Facilitated supportive discussion to assist parents in managing stressors and social determinants 
of health barriers to healthy weight. Each session covers specific objectives, includes a number of complementary, hands-
on activities, and provides participants with take-home materials to facilitate behavior change. Community-AHF will be 
delivered by a nurse and a Community Health Worker (CHW) trained by a consultant nutritionist and study investigators.  
 
If the child has been referred by their pediatrician referring providers will also receive a communication regarding the family’s 
participation. Once the child starts a cohort there will be an additional communication to the referring provider when the 
child completes the 4-month active phase. This communication will include a summary of family goals for healthy child 
weight, the current BMI, and a reminder that the child should have a follow up visit with the referring provider. The consent 
process will include specific permission for this release of information to the referring provider and/or signing of a separate 
release of information of form based on IRB determination. 
 
Parent-completed surveys during home visits will include information on parent, child and family sociodemographic 
characteristics, covariates of interest (e.g., child sleep and screen media use) and scales/measures used to determine 
secondary outcomes. Family sociodemographic characteristics will be measured at baseline only. The follow-up survey will 
include brief measures of satisfaction with the Community-AHF intervention, acceptability and feasibility. Parent-completed 
surveys will be administered via guided oral administration by the research staff member and all answers will be entered 
directly into a REDCap electronic survey form to allow for simultaneous data capture and storage. The exception to this is 
the responses to the secondary outcome diet measure (Block Hispanic Food Frequency Questionnaire) which will be 
entered into a proprietary web interface provided by NutritionQuest. We have used guided oral administration in our past 
research with similar study populations to allow for survey completion by populations with limited literacy and who may be 
unfamiliar or uncomfortable with electronic survey formats. Participants will be given the option to complete the survey on 
their own via a study computer with the research staff member present.  
 
Another data component of the home visits is a home food inventory that will be completed by the research staff members 
by visualizing food stored in the home and recording types of food and quantity. The parent completing the survey will guide 
the research staff member to food stored in the home. The research staff will record responses and home food inventory 
information into the REDCap electronic survey. The research staff member will also complete anthropometric 
measurements to calculate BMI by twice measuring height to the nearest 0.1cm and weight (light clothing, no shoes) to the 
nearest 0.1kg using stadiometers (Hopkins Road Rod) and portable digital scales (Seca 874), respectively. All 
anthropometric measurements will be recorded in REDCap by the research staff member. In lieu of a home visit, participants 
can complete data collection visits in a private space at either of the research institutions involved in the proposed work or 
at the community organization.  
 

 
Regarding physical activity measurement using accelerometers, research staff will provide the index parent/child dyad with 
a ActiGraph GT9X Link accelerometer at each data collection home visit and instruct them to have their child to wear it like 
a watch on the non-dominant wrist for seven consecutive days and nights and to remove it only for aquatic activities (e.g., 
swimming, bathing) and group sports that prohibit wearing jewelry or watches (e.g., basketball, soccer). Study staff will 
provide participants with contact information for any questions/concerns about the accelerometer. After 7 days, participants 
will return the accelerometers to the community organization involved in the study or via prepaid protective envelopes based 
on participant preference. After receiving the device, research staff will wipe it with the alcohol disinfecting cloth, download 
the data and set it up for redistribution to the next participant. 
 
 
D. RISKS AND BENEFITS:  
The risks of anthropometric measurements are discomfort and emotional upset. For accelerometry in particular there may 
be a perceived risk of external monitoring or “tracking”. Accelerometer data is not generated through real-time tracking and 
the location of participants is not recorded by the device. Data collected by the accelerometer can only be accessed when 
the device is returned and accessed via specialized proprietary software. If the device is lost or stolen, it is extremely unlikely 
that data could be accessed. If accessed, participant information other than activity data would not be available. The only 
risk of the surveys and of EHR data extraction is breach of confidentiality. The risk of the home visit for data collection is 
breach of confidentiality and discomfort with having study staff enter the home. Breach of confidentiality will be strictly 
guarded against, and any unintentional breach of confidentiality would not be anticipated to affect the employability, 
reputation, or financial status of a participant. 
 
The primary risk of follow-up interviews is breach of confidentiality and  will be strictly guarded against, and any unintentional 
breach of confidentiality would not be anticipated to affect the employability, reputation, or financial status of a participant. 
Additionally, participants may also feel uncomfortable providing negative feedback about Community-AHF or its 
implementation. 
 
Protection Against Risk – The primary risk across all aims is breach of confidentiality. We will ensure that personally 
identifiable information, including lists of potential participants, will be stored in secure environments. Documents, interview 
transcripts and survey data will be stored in locked file cabinets and data will be stored on secure computers protected by 
University of Colorado (CU) and Johns Hopkins University security protocols. Both institutions have state-of-the-art 
information technology to assure high security in data storage and transfer. No identifiable data will be stored on personal 
computers or devices. The proposal will be reviewed and approved by COMIRB prior to any work being done. We will take 
the following additional steps to protect privacy and confidentiality:  
• Only the study team will have access to identifying information.  
• Each study participant will be assigned a unique identification (ID) number at the time of recruitment to de-identify their 
name from data. The database linking the ID with the participant will only be accessible to select research staff (Multi-
PI, site research coordinator, data manager)  
• Audio files will be uploaded within 24 hours to a secure network drive that is password protected and backed up regularly.   
• After uploading the audio file, it will be deleted from the recorder.   
• Once transcribed by professional transcription services that meet HIPAA privacy and confidentiality standards, textual 
data will be uploaded to this same server and only analyzed from password-protected devices that can access this 
server.  
• For the surveys, individual subjects’ survey responses will be confidential through the use of REDCap. 
Benefits – There are many potential health benefits to participants in endeavoring to reduce child BMI, including lower adult 
cardiovascular disease risk. Although past research has demonstrated benefit from receiving the type of intervention that 
we will deliver in this trial, confirmed benefit from participating in this research cannot be claimed, as we are testing an 
adaption of an evidence-based intervention in new communities. Regardless of intervention effectiveness, the potential 
benefits for the study participant include receiving information regarding healthy behaviors and positive parenting skills. 
Given that the risks are minimal and the potential for positive health benefits, we believe that the benefits of the proposed 
project far outweigh any risks. 
 
E. POTENTIAL SCIENTIFIC PROBLEMS:  
Likewise, some dyads  will not wish to complete all aspects of the pilot study. We will work with families to complete 
measures that they feel comfortable with. Acceptance or denial of study procedures will provide important information for a 
future larger scale trial.  
 
F. DATA ANALYSIS PLAN:   
Indicators of Effectiveness 
As this is a pilot study, we will not be powered to detect statistically significant differences pre- and post- intervention. We 
will measure the average change in %BMIp95 between baseline and completion of the Community-AHF active phase. 
Without a counterfactual (control group) we will not be able assign responsibility to Community-AHF for any observed 

 
improvements. Change in %BMIp95 across the study period will provide data to test our hypotheses and will inform statistical 
power analyses for a subsequent trial. This pre- and post-intervention data is ideal for generating sample size estimates for 
a larger randomized control trial in the same population. 
We will conduct within-individual analyses for each outcome of interest. We will only analyze participants who contribute 
pre and post measures in order to avoid biases that can occur when analyses are conducted with all available data. For 
each outcome for which a participant contributes pre and post measurements, we will calculate pre and post means, 
standard deviations, differences in means and the p-value of the difference. We will conduct preliminary analyses of 
outcomes according to subgroups defined by rate of attendance at intervention sessions. If adequate data are available, we 
will explore the possibility of a nonresponse analysis. 
All statistical analyses will be conducted using Mplus, or the latest version of R (specifically the nlme package).21 
Preliminary Implementation Evaluation  
Survey measure results will be summarized using descriptive statistics. Qualitative data from follow-up interviews will be 
analyzed using rapid qualitative methods as we anticipate a short time frame between obtaining these data and refinement 
of the implementation protocol in preparation for a future trial if funded. Interview transcripts will be summarized in a template 
based on the guiding questions to capture key points. Summarizing will be completed by the research team who will resolve 
differences through consensus. Using matrix analysis techniques22, summaries will be categorized by site and participant 
type (parent, child or community organization staff member). Two research team members will independently identify and 
group key themes from summaries, and then compare themes. Finally, a saturation grid24, which visually aligns support for 
themes, will be developed to cross-check and confirm evidence of themes against the dataset.  
Data Management – Audio recordings will be stored in a UC-Anschutz secure encrypted database. REDCap will serve as 
the storage system for surveys. Only the PI, data analysts, and research staff will have access to the data. All identifiable 
information will be restricted for contact information only and will be separated from other study data. All identifiable 
information will be removed from audio recordings and survey data. Consent forms will be stored in a locked cabinet at the 
sites ACCORDs for Aurora Community Connection and Johns Hopkins Bayview Medical Center, MD. Due to the nature of 
the pilot, consent forms will be transferred from the home of the participant to the site. In these cases, the consent forms 
will not be left unsupervised during transport and will be placed in a locked cabinet immediately upon reaching the site 
destination. Research staff will minimize additional trips to obtain consent from participants in order to safeguard 
confidentiality. 
 
Date Destruction – Paper consent forms and data stored on servers will be destroyed per HIPAA regulations (7 years after 
IRB of record acknowledges study closure). 
 
G. SUMMARIZE KNOWLEDGE TO BE GAINED:   
The findings from the proposed research will directly impact pediatric primary care practice and treatment of child obesity. 
This proposed study will answer a pivotal question about whether community-based weight management can successfully 
reduce overweight and obesity among Latino children. Overall, the knowledge to be gained by this study is valuable enough 
that the minimal risks of the study are reasonable in relation. 
 
H. 
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