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Latino Families, Primary Care, and Childhood Obesity

A Randomized Controlled Trial

      Background

      Few successful treatment modalities exist to address childhood obesity. Given Latinos' strong identity with family, a family-focused intervention may be able to control Latino childhood obesity.

      Purpose

      To assess the feasibility and effectiveness of a family-centered, primary care–based approach to control childhood obesity through lifestyle choices.

      Design

      Randomized waitlist controlled trial in which control participants received the intervention 6 months after the intervention group.

      Setting/participants

      Forty-one Latino children with BMI >85%, aged 9–12 years, and their caregivers were recruited from an urban community health center located in a predominantly low-income community.

      Intervention

      Children and their caregivers received 6 weeks of interactive group classes followed by 6 months of culturally sensitive monthly in-person or phone coaching to empower families to incorporate learned lifestyles and to address both family and social barriers to making changes.

      Main outcomes measures

      Caregiver report on child and child self-reported health-related quality of life (HRQoL); metabolic markers of obesity; BMI; and accelerometer-based physical activity were measured July 2010–November 2011 and compared with post-intervention assessments conducted at 6 months and as a function of condition assignment. Data were analyzed in 2012.

      Results

      Average attendance rate to each group class was 79%. Socio-environmental and family factors, along with knowledge, were cited as barriers to changing lifestyles to control obesity. Caregiver proxy and child self-reported HRQoL improved for both groups with a larger but not nonsignificant difference among intervention vs control group children (p=0.33). No differences were found between intervention and control children for metabolic markers of obesity, BMI, or physical activity.

      Conclusions

      Latino families are willing to participate in group classes and health coaching to control childhood obesity. It may be necessary for primary care to partner with community initiatives to address childhood obesity in a more intense manner.

      Trial registration

      This study is registered at Clinicaltrials.partners.org 2009P001721.

      Introduction

      Obesity is a complex disorder involving biology, physical environments, societal structures, and cultural determinants.
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      Cultural conflicts in the weight loss experience of overweight Latinos.
      Obesity is one of the most prevalent childhood chronic health conditions.
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      The increase of childhood chronic conditions in the U.S..
      DHHS
      Division of nutrition, physical activity, and obesity.
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      Racial, ethnic, and socioeconomic disparities in the prevalence of obesity are well documented.
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      Differences in prevalence of obesity among Black, White, and Hispanic adults—U.S., 2006–2008.
      In 2010, among those aged 2–19 years, 21% of Hispanics were obese compared to 14% of non-Hispanics.
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      Prevalence of obesity and trends in the distribution of body mass index among U.S. adults, 1999–2010.
      Many Latino children face barriers to maintaining a healthy weight, including lack of affordable healthy foods in their neighborhoods, dangerous neighborhoods that make being active outdoors difficult, and a lack of culturally relevant community activities.
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      Treating obesity has proven difficult.
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      Current standard medical care relies on primary care providers providing counseling on diet and exercise, at routine visits that are months apart.
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      Cost-effective approaches to promote healthy lifestyle choices among Latino children are needed to reduce obesity rates.
      Children whose parents are overweight are more likely to be overweight
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      and are at an increased risk of obesity as adults.
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      Thus, addressing risk factors for childhood obesity requires addressing family behaviors including diet and physical activity.
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      Family-centered approaches have been successful in supporting healthy eating and physical activity in children.
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      Family-centered approaches may be particularly relevant to Latino communities, given Latinos' sense of familismo,
      • Marín G.
      • Triandis H.
      Allocentrism as an important characteristic of Latin-Americans and Hispanics.
      which is valuing the family as central to behaviors and decisions.
      To address challenges common to Latino communities, the authors piloted Healthy Living Today!, a family-centered, primary care–based approach to weight control. Tests were made of the feasibility and effectiveness of this novel pilot program, which included six interactive group classes focused on nutrition, physical activity, and stress management, followed by 6 months of monthly in-person or phone health coaching. We hypothesized that (1) Latino families would be willing to participate in an augmented primary care approach to treat obesity; and (2) children participating in the intervention would have improved quality of life, metabolic markers of obesity, BMI, and physical activity.

      Methods

      Study Design

      Participating dyads were sequentially randomized to the intervention or control group in a 3:2 ratio during the first half of the study, and then 2:2 during the second half of the study to adequately fill the group classes. Intervention participants began classes immediately, with control participants waiting 6 months prior to beginning the intervention, immediately following their 6-month assessment. Both intervention and waitlist control participants completed evaluation protocols at baseline and 6-months post-baseline. Caregiver consent and child assent were obtained. Participating families were given a $15 gift certificate at the first visit and a $25 gift certificate at the second visit. This study was approved by the Partners IRB.

      Participants

      Eligible participants were Latino children ages 9–12 years who were overweight or obese (age- and gender-specific BMI in the 85th–94th and ≥95th percentile, respectively) who received primary care at a single community health center. Participants were identified by their primary care pediatrician and then recruited by phone. Children with chronic diseases other than asthma were excluded. Given population-wide physical activity levels among children aged 9–12 years,
      • Nader P.R.
      • Bradley R.H.
      • Houts R.M.
      • McRitchie S.L.
      • O'Brien M.
      Moderate-to-vigorous physical activity from ages 9 to 15 years.
      to have an 83% probability of detecting a 9% increase (12 minutes) in mean average daily physical activity in the intervention group, the current authors anticipated that 21 children in each group would be required.

      Intervention

      The intervention consisted of two components: (1) Power Up classes that educated children and caregivers about healthy behaviors surrounding nutrition, activity, and stress management and (2) culturally sensitive coaching to empower families to incorporate learned behaviors and address both family and social barriers to lifestyle changes. Classes were conducted in five consecutive weekly sessions, with a sixth 3 months later. Coaching began concurrently with the group classes and continued for a total of 6 months; meetings were in-person at the health center, at the families' home, or by phone. Ideal contact occurred monthly, although frequency and modality varied according to family preference. Classes occurred at the health center but outside of the pediatric practice in order to avoid pre-exposure for the waitlist control group.

      Power Up

      Families attended interactive classes aimed at education and support in choosing healthy behaviors with the goal of reducing childhood obesity. Power Up is a 1.5-hour interactive curriculum for overweight/obese children and their caregivers offered at an urban community health center during early evening hours. It is based on the 2007 American Association of Pediatricians (AAP) Obesity Guidelines
      • Barlow S.E.
      Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report.
      and the 2008 DHHS Physical Activity Guidelines for Children and Adolescents.
      DHHS
      2008 physical activity guidelines for Americans.
      DHHS
      Active children and adolescents. In Physical activity guidelines for Americans.
      Children and their caregivers were grouped separately, and participated in interactive games and activities (i.e., nutrition jeopardy, in-door jump-rope, and food pyramid bingo) that model behavior. Classes were led by a team of a health educator, physical therapist, nutritionist, and primary care pediatrician. Topics included portion control, healthy snacking, the dangers of liquid calories, label reading, goal setting, TV viewing, making changes as a family, the relationship between stress and overeating, stress reduction, and fitting physical activity into daily life. Classes allowed for open discussion between the leader and the participants, who were encouraged to offer suggestions to the group.
      Sessions ended with a physical activity component, which included instruction in the importance of warming up, stretching, and maintaining adequate hydration during exercise. Lessons were reinforced at home via the use of journals, assignments, and give-away items to promote physical activity at home (i.e., balls for children and pedometers for caregivers). At a reunion session 3 months later, participants reviewed prior topics, and discussed their progress with lifestyle changes and self-image.

      Health coaching

      Coaching was modeled on a successful Latino adult diabetes program (ESFT Model)
      • Betancourt J.R.
      • Carrillo J.E.
      • Green A.R.
      Hypertension in multicultural and minority populations: linking communication to compliance.
      and tailored to include the child and family, focusing on opportunities and solutions to behaviors affecting weight. ESFT emphasizes cultural sensitivity and relationship building to reveal patients' Explanatory model, Social barriers, Fears and understanding of Treatment.
      • Betancourt J.R.
      • Carrillo J.E.
      • Green A.R.
      Hypertension in multicultural and minority populations: linking communication to compliance.
      The coach supported families to overcome barriers, and provided accountability for family goal setting and progress toward these goals. The coach also empowered families to access community resources for healthy food choices and physical activity.
      All families met with the coach in person at least once, followed by periodic in-person or phone meetings during the 6 months after enrollment. Home visits were offered and families were encouraged to have contact with the coach at least monthly; however, each family's preferences and needs dictated the setting and timing of meetings. Family cases were documented in field notes, which were inductively coded to cite barriers to achieving lifestyle changes or participation.

      Data Collection

      Data were collected between July 2010 and November 2011 and analyzed in 2012.

      Self-reported measures

      Health-related quality of life (HRQoL) was assessed using the PedsQL™ child self-report and caregiver proxy report generic core scales.
      • Varni J.W.
      • Burwinkle T.M.
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      • Skarr D.
      The PedsQL 4.0 as a pediatric population health measure: feasibility, reliability, and validity.
      • Varni J.W.
      Pediatric quality of life inventory version 4.0.
      The PedsQL™ provides information on the physical, emotional, social, and school-related aspects of HRQoL using a 5-point rating scale and asking about the previous month period. Scales range from 0 to 100, with higher scores indicating better HRQoL
      The PedsQL scoring algorithm.
      Psychometric alphas of 0.92 and 0.90 for measuring HRQoL among healthy populations and children with chronic conditions are reported.
      • Varni J.W.
      • Burwinkle T.M.
      • Seid M.
      • Skarr D.
      The PedsQL 4.0 as a pediatric population health measure: feasibility, reliability, and validity.
      • Varni J.W.
      • Seid M.
      • Kurtin P.S.
      PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations.
      The PedsQL™ has been validated among Spanish- and English-speaking Hispanic groups.
      • Newman D.A.
      • Limbers C.A.
      • Varni J.W.
      Factorial invariance of child self-report across English and Spanish language groups in a Hispanic population utilizing the PedsQL™ 4.0 generic core scales.
      Nutrition knowledge and intake were assessed by the School Physical Activity and Nutrition (SPAN) questionnaire, a validated survey that assesses dietary and physical activity behavior, attitudes, and knowledge.

      Thiagarajah K, Bai Y, Lo K, et al. Assessing validity of food behaviour questions from the School Physical Activity and Nutrition Questionnaire. Proceedings of the 39th Annual Meeting of the Society for Nutrition Education; 2006; San Francisco CA.

      • Hoelscher D.M.
      • Day R.S.
      • Kelder S.H.
      • Ward J.L.
      Reproducibility and validity of the secondary level School-Based Nutrition Monitoring student questionnaire.
      • Hoelscher D.M.
      • Day R.S.
      • Lee E.S.
      • et al.
      Measuring the prevalence of overweight in Texas schoolchildren.
      • Penkilo M.
      • George G.C.
      • Hoelscher D.M.
      Reproducibility of the School-Based Nutrition Monitoring Questionnaire among fourth-grade students in Texas.
      • Thiagarajah K.
      • Fly A.D.
      • Hoelscher D.M.
      • et al.
      Validating the food behavior questions from the elementary school SPAN questionnaire.
      SPAN includes 24-hour recall questions, with responses ranging from 0 to ≥3, and tests nutrition knowledge and attitudes. Agreement for food intake questions is reported at 70%–98%, with κ statistics ranging from 0.54 to 0.93 and correlations between 0.66 and 0.97.
      • Hoelscher D.M.
      • Day R.S.
      • Kelder S.H.
      • Ward J.L.
      Reproducibility and validity of the secondary level School-Based Nutrition Monitoring student questionnaire.
      The initial validation population included 41% Hispanics. This questionnaire was piloted and collected only on a subset of participants (n=19, 46%).

      Body composition and metabolic measures

      Anthropomorphic data were collected by trained Harvard Catalyst Clinical Translational Science Center (CTSC) research dietitians. The data included height and weight measured in duplicate with a stadiometer and electronic scale, used to calculate each participant's BMI using age- and gender-specific CDC growth curves, then transformed to BMI z-scores using SAS for CDC Growth Charts (www.cdc.gov/nccdphp/dnpao/growthcharts/resources/sas.htm).

      Metabolic markers

      Lipids; glucose; insulin; hemoglobin A1c (HbA1c); alanine aminotransferase–aspartate aminotransferase ratio (AST/ALT); C-reactive protein; interleukin 6 (IL-6); and tumor necrosis factor α (TNF-α) and other markers were collected by venipuncture by CTSC nurses using standard protocols. Samples were processed by CTSC laboratories using published industry assays. IL-6 and insulin were analyzed by using Access Chemiluminescent Immunoassay kit (Beckman Coulter). TNF-α was analyzed with Enzyme-linked Immunosorbent Assay kit (R & D Systems Inc). Lipids and glucose were analyzed by enzymatic testing with CHOD-PAP and Gluco-quant Glucose/HK kits (Roche) respectively. HbA1c was done using the Tina-quant HbA1c Gen.2 kit (Roche). C-reactive protein was tested using the Cobras Integra Cardiac C-Reactive Protein (Latex) High sensitivity kit (Roche).

      Physical activity measure

      Physical activity data were collected over 5 weekdays and 2 weekend days using GT1M ActiGraph accelerometers, worn around the hip, a validated tool for assessing objective physical activity in children.
      • Sirard J.R.
      • Melanson E.L.
      • Li L.
      • Freedson P.S.
      Field evaluation of the Computer Science and Applications, Inc. physical activity monitor.
      Acceleration in the vertical field was used to calculate physical activity counts at 30-second intervals. Data were then reintegrated into 1-minute time periods for analyses.
      A valid day was defined as ≥8 hours of accelerometer wear with a minimum of 10% nonzero epochs per hour to be a valid hour; participants who had at least 1 valid day at both baseline and follow-up visits were included in analyses. Although 4 or more valid days is commonly used to estimate children's physical activity,
      • Trost S.G.
      • McIver K.L.
      • Pate R.R.
      Conducting accelerometer-based activity assessments in field-based research.
      applying this standard would have decreased this pilot study's sample of subjects providing physical activity data by more than 83% and would not have allowed for physical activity assessment. Valid accelerometer data were available for participants on at least 1 (94.4%); 2 (88.8%); 3 (77.7%); or ≥4 (72.2%) days at Visit 1, and at least 1 (88.8%); 2 (85.2%); 3 (80.5%); or ≥4 (70.5%) days at Visit 2.

      Data Processing

      Physical activity measure

      Accelerometer data were downloaded to a computer using ActiLife software from which each child's total daily minutes of moderate- to vigorous-intensity physical activity (MVPA) were calculated using age-appropriate counts-per-minute cutpoints.
      • Evenson K.R.
      • Catellier D.J.
      • Gill K.
      • Ondrak K.S.
      • McMurray R.G.
      Calibration of two objective measures of physical activity for children.
      For all valid data, each participant's total daily minutes of MVPA and number of valid days were exported to Microsoft Excel where total minutes in moderate and vigorous activity were summed and divided by the number of valid days of accelerometer wear to obtain each participant's mean daily MVPA minutes.

      Data Analysis

      A difference-in-difference analysis was used, which measures the change in each outcome within the group of intervention children and also accounts for any trend not attributable to the intervention by controlling for the measured change in the control group. PedsQL™ items were reverse-scored and linearly transformed to a 0–100 scale and the total score, psychosocial health summary score, and physical health summary score were calculated per survey specifications.
      The PedsQL scoring algorithm.
      Matched case differences in the change in the PedsQL™ scores, metabolic biomarkers, and BMI z-scores were calculated.
      Mixed-effects linear models were used to measure differences in each of the outcome variables. Backward selection of seven control variables was used; variable were chosen based on prior research, including child's age and gender; caregiver BMI; caregiver education; primary language spoken at home (English vs non-English); and average daily temperature. Model variables were chosen based on fit statistics at a p<0.10 significance level due to the small sample size, except average temperature, which was forced into the model for physical activity outcome. Correlation analysis was done to ensure that control variables were not highly correlated with one another. Analysis was done using SAS, version 9.2.

      Results

      A total of 41 participants were enrolled, 18 of whom were in the control group. All 23 intervention participants took part in group classes. Attendance rate to each group class was 79%. Nine percent (2/23) dropped out of coaching and 26% (6/23) missed one mutually scheduled coaching appointment. Reasons given for inability to continue classes and coaching were work schedules, other extracurricular activities, transportation, and child care (although siblings were allowed to participate). Fifteen participants (37%) did not return for Visit 2, either because they were lost to follow-up or withdrew from the study. A total of 67% (12/18) control and 61% (14/23) intervention participants took part in first and second visits (Figure 1).
      Figure thumbnail gr1
      Figure 1Flow diagram of participants through the study
      The final sample included 26 (63%) participants (14 intervention, 12 control). Sensitivity analysis comparing the children's gender, primary language spoken in the home, and caregiver BMI, education, and chronic condition between dyads with incomplete and complete data suggests that those who did not complete both data collections were more likely to have a caregiver with a chronic condition compared to those who completed data collection (p=0.08). Children's age, gender, and BMI z-score, and caregiver education were not different between groups at baseline (Table 1).
      Table 1Summary of demographic characteristics for control and intervention groups, % or M (SD)
      Control n=12Intervention n=14p-value
      Chi-squared analysis or Fisher's exact test and t-tests were used to test significance.
      Gender
       Male41.735.70.22
       Female58.364.3
      Age (years)10.4 (1.2)10.2 (1.3)0.69
      Child percent BMI97.8 (3.1)97.3 (2.1)
       Male, n=1099.3 (0.5)97.6 (1.8)
       Female, n=1696.8 (3.8)97.2 (2.4)
      Child BMI z-score2.2 (0.4)2.0 (0.3)0.33
       Male, n=102.5 (0.2)2.1 (0.3)0.06
       Female, n=162.0 (0.4)2.0 (0.4)0.91
      Primary household language
       English25.021.40.83
       Non-English75.078.6
      Highest caregiver education
       Below high school25.050.00.19
       High school or higher75.050.0
      Caregiver BMI32.4 (6.5)26.7 (1.2)0.06
      Caregiver chronic conditions
      Includes obesity, hypertension, and diabetes mellitus
       Yes41.721.40.27
       No58.378.6
      Immigrant generation
       1st41.764.30.22
       ≥2nd58.335.7
      a Chi-squared analysis or Fisher's exact test and t-tests were used to test significance.
      b Includes obesity, hypertension, and diabetes mellitus
      A majority of control and intervention group participants did not speak English as their primary language at home. The average reported maternal BMI was higher for the control group than the intervention group (32.4 vs 26.7, p=0.06). No differences were observed between groups in accelerometer wear times or counts at baseline or follow-up. However, average valid days among control and intervention participants at Visit 1 were 12.4 and 13.0 hours/day (p=0.68), respectively, and 10.1 and 11.8 hours/day (p=0.09) at Visit 2. Mean total daily accelerometer counts among control and intervention participants at Visit 1 were 1,039,551 and 1,327,725 (p=0.46), respectively, and 1,137,541 and 1,088,754 (p=0.90) at Visit 2.
      During coaching sessions, caregivers most often cited a lack of knowledge about healthy eating as a barrier to addressing their child's weight. This was followed by lack of ability to be physically active. Cited barriers to physical activity were as follows: inability to find places where the family could exercise together, the cost of programs, transportation, competing non-active extracurricular activities, and safety concerns. Safety concerns included physical safety and the potential of meeting others who would encourage risky behaviors in their children. Lack of resources to buy groceries was cited by 26% (6) of families in coaching sessions. Other barriers cited included the inability to control school meals, discordance between caregivers about a child's weight leading to decreased family support, and tensions due to pre-adolescents' emerging independence.

      Self-Reported Measures

      Health-related quality-of-life measures

      There was an overall improvement in the total scale for the control and intervention groups for caregiver proxy and child self-reports (Figure 2). The physical health and psychosocial health subdomains also improved for all participants, with the exception of the control group's child self-report on the psychosocial health subdomain (−2.6 points). In the final models, caregiver scores were controlled for maternal BMI and caregiver education, and child scores were controlled for primary household language and child's gender. There was no significant improvement in PedsQL™ scores in the intervention group (+5.6) or the control group (+0.4; p=0.48).
      Figure thumbnail gr2
      Figure 2Summary of PedsQL total scores for caregiver and child surveys: intervention and control groups
      aAdjusted for primary household language and child's gender
      PedsQL, Pediatric Quality of Life Inventory

      Nutrition knowledge

      Pilot nutritional survey data showed a gap between nutrition knowledge and actual nutrition based on a 24-hour food recall. Knowledge on suggested servings averaged 2.6 for both fruits and vegetables (compared to the correct answer of 5); 29.4% of children reported not knowing the answer. Twenty-four-hour recall of servings of fruit was 1.25, and 0.70 for vegetables. Many children reported eating meals at school always or often (88.2% for lunches and 33.3% for breakfast). Most children (82.4%) reported having a negative perception of school lunches (almost never or never healthy vs always/almost always/sometimes).

      Body Composition and Metabolic Measures

      Anthropomorphic measures

      BMI z-scores did not change significantly for the control group (−0.05) or the intervention group (−0.03). After controlling for caregiver education and maternal BMI, the difference in the change in BMI z-scores between the control and intervention group was not significantly different (p=0.31; Table 2).
      Table 2Pre- and post-intervention BMI z-scores
      Adjusted for caregiver education and maternal BMI
      and metabolic markers
      Adjusted for primary household language
      with unadjusted and adjusted difference-in-difference models
      ControlInterventionDifference-in-difference
      nM (SD)p-valuenM (SD)p-valueUnadjustedAdjusted
      BMI z-score
       Pre2.2 (0.4)2.0 (0.3)
       Post2.1 (0.5)2.0 (0.4)
       Change10−0.05 (0.08)0.1313−0.03 (0.14)0.051.000.31
      LIPIDS (mg/dL)
      Cholesterol
       Pre150.3 (36.3)167.9 (30.2)
       Post151.6 (34.1)159.4 (23.4)
       Change120.9 (16.9)0.8514−8.4 (19.0)0.120.100.08
      Triglycerides
       Pre91.0 (35.6)108.6 (35.7)
       Post89.3 (45.7)113.0 (45.4)
       Change84.5 (20.4)0.5574.4 (62.8)0.861.000.97
      HDL
       Pre48.1 (11.4)47.0 (13.4)
       Post51.5 (12.7)47.7 (14.7)
       Change83.8 (5.8)0.1170.7 (8.4)0.830.420.43
      VLDL
       Pre18.1 (7.1)21.6 (7.2)
       Post17.9 (9.0)22.6 (8.9)
       Change81.0 (3.9)0.4971.0 (12.4)0.841.000.96
      LDL
       Pre85.7 (37.0)87.3 (28.4)
       Post89.6 (33.7)83.3 (23.5)
       Change81.6 (16.1)0.787−4.0 (8.8)0.780.430.44
      LIVER (IU/L)
      AST
       Pre25.6 (7.9)24.1 (5.6)
       Post20.8 (5.9)23.1 (7.2)
       Change11−3.5 (2.7)0.0114−1.1 (4.6)0.400.060.17
      ALT
       Pre24.6 (13.7)24.4 (12.6)
       Post24.7 (18.7)23.4 (15.5)
       Change11−1.9 (3.6)0.1114−1.1 (11.1)0.720.600.49
      GLUCOSE METABOLISM
      HbA1c(%)
       Pre5.6 (0.3)5.7 (0.2)
       Post5.7 (0.3)5.7 (0.3)
       Change110.1 (0.2)0.31120.0 (0.2)0.800.420.38
      Glucose (mg/dL)
       Pre83.3 (4.1)83.7 (17.3)
       Post85.5 (5.2)84.2 (5.6)
       Change82.3 (2.7)0.0561.8 (5.0)0.410.480.80
      Insulin (μIU/mL)
       Pre11.5 (4.9)21.8 (17.3)
       Post13.2 (4.6)24.2 (17.8)
       Change42.2 (2.3)0.6242.4 (10.4)0.320.980.98
      INFLAMMATION
      C-reactive protein (mg/L)
       Pre3.0 (4.0)2.1 (1.8)
       Post4.9 (9.1)2.5 (2.1)
       Change121.8 (5.2)0.25140.4 (1.6)0.420.910.90
      IL-6 (pg/mL)
       Pre3.3 (1.9)2.6 (2.0)
       Post3.4 (2.5)2.2 (0.7)
       Change40.4 (2.2)0.496−0.7 (2.1)0.270.510.55
      TNF-α (pg/mL)
       Pre3.1 (3.8)1.9 (0.8)
       Post1.3 (0.8)1.9 (0.8)
       Change5−0.9 (0.5)0.02100.0 (1.1)0.980.050.14
      ALT, alanine aminotransferase; AST, aspartate aminotransferase; HbA1c, hemoglobin A1c; HDL, high-density lipoprotein; IL, interleukin; LDL, low-density lipoprotein; TNF, tumor necrosis factor; VLDL, very-low-density lipoprotein
      a Adjusted for caregiver education and maternal BMI
      b Adjusted for primary household language

      Metabolic biomarkers

      Over the 6-month period there was no difference in changes between the control and intervention groups. Although not reaching a priori–designated significance levels, the lipid panel showed an average decrease in cholesterol for the intervention group (−8.4 mg/dL) compared to an increase in cholesterol for the control group (0.9 mg/dL) in final models adjusting for household language (p=0.08). Participant non-fasting and laboratory processing problems contributed to variations in the sample size for each test (Table 2).

      Physical activity

      Complete data for the first and second visits were available for four control and 12 intervention participants. The most common reason for an incomplete data pair was loss of the accelerometer device. The average daily MVPA was higher for the intervention group (27.9 minutes) than for the control group (16.8 minutes) at baseline (p=0.03). On average, control group participants had a 1.6-minute (SD=3.2) decrease in daily MVPA compared to a 7.2-minute (SD=19.5) decrease among intervention group participants (p=0.62), corresponding to a 4.8% decrease and 0.3% increase in daily MVPA, respectively. After controlling for age, gender, primary household language, and change in average temperature, difference-in-difference analysis showed no difference in MPVA between the two groups (p=0.88; Table 2).

      Discussion

      Obesity is a multifactorial condition that is influenced by social environments, social networks, and individual decisions that are affected by context. Addressing the childhood obesity epidemic requires interventions at each level of influence, from national policy to individual choice. This pilot project begins to evaluate the feasibility and benefits of treating obesity through a family-centered lifestyle approach delivered in a primary care setting. Family-centered approaches to improving food and physical activity behaviors are increasingly recognized as central components to combating obesity, such as the First Lady's recently launched Let's Move (www.letsmove.gov/.) initiative.
      In a low-income community, Latino families with obese children are willing to participate in early evening sessions that allow for siblings to participate. They are also willing to work with a health coach. Social factors such as work hours, extracurricular activities, transportation, and child care hindered participation. Many caregivers cited factors that were out of their control as challenges to adopting healthy behaviors. These included the inability to find family encompassing physical activities and to control what their child chooses to eat, emerging independence, and social stressors such as family discord, financial stress, and time pressures. However, because of lack of statistical power and families missing return visits needed solely for data collection, it was not possible to show that combining child and caregiver interactive education with health coaching may provide benefits over routine medical care.
      The low quality-of-life scores observed among all participants suggest that obesity has a substantial impact on Latino children's quality of life. Latino children and their caregiver proxies reported PedsQL scores that are below ranges of children with cancer
      • Varni J.W.
      • Burwinkle T.M.
      • Katz E.R.
      • Meeske K.
      • Dickinson P.
      The PedsQL™in pediatric cancer.
      or diabetes
      • Varni J.W.
      • Burwinkle T.M.
      • Jacobs J.R.
      • Gottschalk M.
      • Kaufman F.
      • Jones K.L.
      The PedsQL™ in type 1 and type 2 diabetes.
      and even lower than scores previously reported among obese children in general.
      • Williams J.
      • Wake M.
      • Hesketh K.
      • Maher E.
      • Waters E.
      Health-related quality of life of overweight and obese children.
      • Schwimmer J.B.
      • Burwinkle T.M.
      • Varni J.W.
      Health-related quality of life of severely obese children and adolescents.
      Possible explanations include direct health consequences such as joint pain and asthma, and impacts of obesity such as bullying, self-esteem, or body image. However, given that the present study was conducted in a low-income urban community, the influences that financial stress, racism, and bias have on this population cannot be discounted. Although changes in HRQoL scores over a 6-month period among the intervention group appeared larger than in the control group, there was no significant difference between the two groups' changes.
      Overall, the study found no differences among those receiving educational classes and coaching compared to controls. No differences in changes in BMI or metabolic markers were found between intervention and control group. No differences were noted in physical activity levels between the groups, with activity declining among both groups. These findings may be due to families requiring a more-intensive intervention that includes scheduled coaching and/or changes to the environmental context. The lack of significant findings may also be due to the small sample size.
      The current findings suggest that improving school meal programs may offer a key potential community intervention. More than 80% of children in the pilot reported receiving meals at school consistent with state data.
      Massachusetts Department of Environmental and Secondary Education
      2011–2012 district profile.
      Although school meals followed U.S. Department of Agriculture (USDA) regulations,
      U.S. Department of AgricultureFood and Nutrition Service
      National School Lunch Program fact sheet.
      more than two thirds of children reported that their school meals were unhealthy. This points to the wide range of possible food options, some healthy, other less so, that qualify for school meal programs under USDA regulations.
      Newly issued regulations will begin to go into effect to improve dietary balance in 2013–2014. Nationally, in fiscal year 2010, more than 31.7 million and more than 11.6 million children participated each day in the National School Lunch
      U.S. Department of AgricultureFood and Nutrition Service
      National School Breakfast Program fact sheet.
      and National School Breakfast Programs,
      U.S. Department of AgricultureFood and Nutrition Service
      National School Breakfast Program fact sheet.
      respectively. Given the reach of school meal programs, community initiatives that aim to ensure implementation of regulations and maximize the nutritional quality of foods served in school could succeed both as population-level prevention intervention and population-level therapeutic intervention for obese children.

      Limitations

      The scope of the current results is limited because of power and generalizability. The sample size was small and fairly homogenous as it was drawn exclusively from a low-income, predominantly Latino community. Thus, findings are limited to populations that share these characteristics. However, this is a population that has traditionally not participated in research studies
      • Kelly M.L.
      • Ackerman P.D.
      • Ross L.F.
      The participation of minorities in published pediatric research.
      • Ford J.G.
      • Howerton M.W.
      • Lai G.Y.
      • et al.
      Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review.
      ; thus, the current study provides needed insight into how to involve Latinos in research.
      Although participants were randomized, because of the waitlist study design, neither participants nor study team members were blinded to group allocation. This may have resulted in bias, although the null effects suggest otherwise. In addition, numerous measures in the evaluation protocol were not subject to self-report bias (e.g., biomarkers and other measured data). Analysis was hindered by loss to follow-up among participants, thereby decreasing statistical power. Future initiatives working with similar communities must focus attention on explaining randomized trials, keeping participants engaged throughout the study, and tying data collection to visits that have additional value to participants.
      One alternative strategy for engaging community members, which may be particularly important in studies involving under-represented populations, is community-based participatory research.
      • De Las Nueces D.
      • Hacker K.
      • Digirolamo A.
      • Hicks L.S.
      A systematic review of community-based participatory research to enhance clinical trials in racial and ethnic minority groups.
      In community-based participatory research, participants are engaged members along every stage of the project, from problem and resource identification, to study design, to recruitment and data collection, and ultimately to dissemination of the findings.
      Although the current study worked to engage the community, and the health coach incorporated and adjusted her specific recommendations to accommodate community aspects, it did not utilize the rigor of the community-based participatory research model, which may be successful in minimizing loss to follow-up.

      Conclusion

      Healthy Living Today!, an interactive educational program that models behavior coupled with family coaching to empower families to incorporate learned material into family and child lifestyles, has some promise for augmenting the standard of care for obesity treatment of children. It appeals to Latino's sense of “familismo
      • Perez G.K.
      • Cruess D.
      The impact of familism on physical and mental health among Hispanics in the U.S..
      and attempts to address individual and family barriers to success in the self-management of obesity. The current study showed that families are willing to participate, but further studies are needed to show that such models will provide clinical benefits over current models.
      This study is in line with other obesity interventions showing null to minimal changes in outcomes.
      • Thomas H.
      Obesity prevention programs for children and youth: why are their results so modest?.
      As participants in the current study described the socio-environmental barriers that limit their ability to adopt healthy behaviors, we argue for the need to address childhood obesity at numerous levels, including national, state, and community policies. Public assistance programs provide some relief in families' financial stressors, have the potential to support healthy lifestyle changes, and can even directly intervene in children's eating habits, as in the case of school meals.
      Further work is needed to better understand the interplay between socio-environmental factors, family, and individual barriers to treating obesity. One promising strategy emerging through the CDC's Healthy Communities Programs and the U.S. YMCA is a focus on improving the built environment, especially in low-income communities, as a means to boost physical activity among families.
      Increased access to recreational sites/facilities.
      Caregivers in the present study articulated a need for community settings where caregivers and children could exercise together. At the same time, they cited safety concerns as a barrier to physical activity. Community-level interventions that engage municipal community development officials in an effort to renovate and build public park spaces that are well-utilized, well-lit, and appealing to family members across a wide age span may be especially important for Latino populations.
      Increased access to recreational sites/facilities.
      • Lutfiyya M.N.
      • Garcia R.
      • Dankwa C.M.
      • Young T.
      • Lipsky M.S.
      Overweight and obese prevalence rates in African American and Hispanic children: an analysis of data from the 2003-2004 National Survey of Children's Health.
      • Osypuk T.L.
      • Diez Roux A.V.
      • Hadley C.
      • Kandula N.R.
      Are immigrant enclaves healthy places to live? The Multi-ethnic Study of Atherosclerosis.
      • Sen B.
      • Mennemeyer S.
      • Gary L.C.
      The relationship between perceptions of neighborhood characteristics and obesity among children.
      • Burdette H.L.
      • Whitaker R.C.
      A national study of neighborhood safety, outdoor play, television viewing, and obesity in preschool children.
      As local communities seek to address the rising obesity prevalence by identifying the socio-environmental factors that influence youth weight gain in the community, accompanying local, state, and federal policies must be in place to improve and monitor the quality of foods served in schools, and provide adequate, public physical activity spaces, regardless of neighborhood demographics. Throughout, organized medicine must likewise find models that effectively and compassionately address each individual's experience of obesity.
      Publication of this article was supported by the Robert Wood Johnson Foundation.
      This study was funded by the Robert Wood Johnson Foundation through its national program, SaludAmerica! The RWJF Research Network to Prevent Obesity Among Latino Children (www.salud-america.org). Salud America!, led by the Institute for Health Promotion Research at The University of Texas Health Science Center at San Antonio, Texas, unites Latino researchers and advocates seeking environmental and policy solutions to the epidemic.
      The study was also supported by the Massachusetts General Hospital Multicultural Affairs Career Development Award. The authors acknowledge the partnership of the Massachusetts General Hospital Disparities Solution Center. In addition, the authors acknowledge the generous support from the Harvard Catalyst Clinical Research Center , Grant No. 1 UL1 RR025758-01 , NIH, National Center for Research Resources, General Clinical Research Centers Program. Finally, we would like to acknowledge Dhruv Khullar for his excellent work as a research assistant in helping to set up the initial phase of this project.
      No financial disclosures were reported by the authors of this paper.

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