Prenatal and Pediatric Primary Care-Based Child Obesity Prevention Program: A Randomized Trial.
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ABSTRACT: Objectives
To determine impact of a primary care-based child obesity prevention intervention beginning during pregnancy on early childhood weight outcomes in low-income Hispanic families.Methods
A randomized controlled trial comparing mother-infant pairs receiving either standard care or the Starting Early Program providing prenatal and postpartum nutrition counseling and nutrition parenting support groups targeting key obesity-related feeding practices in low-income groups. Primary outcomes were reduction in weight-for-age z-scores (WFAzs) from clinical anthropometric measures, obesity prevalence (weight for age ≥95th percentile), and excess weight gain (WFAz trajectory) from birth to age 3 years. Secondary outcomes included dose effects.Results
Pregnant women (n = 566) were enrolled in the third trimester; 533 randomized to intervention (n = 266) or control (n = 267). Also, 358 children had their weight measured at age 2 years; 285 children had weight measured at age 3 years. Intervention infants had lower mean WFAz at 18 months (0.49 vs 0.73, P = .04) and 2 years (0.56 vs 0.81, P = .03) but not at 3 years (0.63 vs 0.59, P = .76). No group differences in obesity prevalence were found. When generalized estimating equations were used, significant average treatment effects were detected between 10-26 months (B = -0.19, P = .047), although not through age 3 years. In within group dose analyses at 3 years, obesity rates (26.4%, 22.5%, 8.0%, P = .02) decreased as attendance increased with low, medium, and high attendance.Conclusions
Mean WFAz and growth trajectories were lower for the intervention group through age 2 years, but there were no group differences at age 3. Further study is needed to enhance sustainability of effects beyond age 2.
SUBMITTER: Messito MJ
PROVIDER: S-EPMC7546096 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveTo determine the effects of a child obesity prevention intervention, beginning in pregnancy, on infant feeding practices in low-income Hispanic families.Study designThe Starting Early randomized controlled trial enrolled pregnant women at a third trimester visit. Women (n = 533) were randomly allocated to a standard care control group or an intervention group participating in prenatal and postpartum individual nutrition/breastfeeding counseling and subsequent nutrition and parenting support groups coordinated with well-child visits. Outcome measures included infant feeding practices and maternal infant feeding knowledge at infant age 3 months, using questions adapted from the Infant Feeding Practices Study II and an infant 24-hour diet recall.ResultsA total of 456 families completed 3-month assessments. The intervention group had higher prevalence of exclusive breastfeeding on the 24-hour diet recall (42.7% vs 33.0%, P = .04) compared with controls. The intervention group reported a higher percentage of breastfeeding vs formula feeding per day (mean [SD] 67.7 [39.3] vs 59.7 [39.7], P = .03) and was less likely to introduce complementary foods and liquids compared with controls (6.3% vs 16.7%, P = .001). The intervention group had higher maternal infant feeding knowledge scores (Cohen d, 0.29, 95% CI .10-.48). The effect of Starting Early on breastfeeding was mediated by maternal infant feeding knowledge (Sobel test 2.86, P = .004).ConclusionsStarting Early led to increased exclusive breastfeeding and reduced complementary foods and liquids in 3-month-old infants. Findings document a feasible and effective infrastructure for promoting breastfeeding in families at high risk for obesity in the context of a comprehensive obesity prevention intervention.Trial registrationClinicalTrials.gov: NCT01541761.
| S-EPMC4925185 | biostudies-literature
Project description:ObjectiveRapid infant weight gain is associated with later obesity. Novel interventions to prevent rapid infant weight gain that are accessible to infants and families are needed, especially for those at the highest risk. Our aims were to examine: (a) feasibility and acceptability of a responsive parenting intervention delivered via Integrated Behavioral Health (IBH) in pediatric primary care and (b) preliminary effects on infant weight gain from birth to 6 (post-treatment) and 9 (follow-up) months.MethodsA parallel design, proof-of-concept randomized control trial was conducted with 65 mother-infant dyads (32 randomized to intervention, 33 randomized an IBH attention control focused on promoting healthy mental health), in which the majority identify as Black (80%) and low income (91% receiving Medicaid). Participants and assessors were masked to treatment condition. Outcomes included feasibility (enrollment), acceptability (retention and adherence), and conditional weight gain (CWG), an indicator of rapid weight gain.ResultsThe intervention was feasible (90% of eligible families enrolled) and acceptable (89% of families retained), with 81% receiving ≥3 of 4 treatment sessions. A medium effect was found on CWG (d = -0.54 post-treatment, d = -0.57 follow-up), with the infants in the treatment group showing significantly lower CWG (mean = -0.27, 95% CI, -0.63, 0.09) compared to the control group (mean = 0.29, 95% CI, -0.17, 0.76) at 9 months (p = .04).ConclusionsThis study demonstrates the feasibility of implementing a responsive parenting obesity prevention intervention within primary care. Delivery in pediatric primary care is advantageous for implementation and reaching at-risk populations. The preliminary effects on CWG are promising and support testing in a larger trial.
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Project description:BACKGROUND:Leading medical organizations have called on primary care pediatricians to take a central role in the prevention of childhood obesity. Weight counseling typically has not been incorporated into routine pediatric practice due to time and training constraints. Brief interventions with simple behavior change messages are needed to reach high-risk children, particularly Latino and Black children who are disproportionately affected by obesity and related comorbidities. Steps to Growing Up Healthy (Added Value) is a randomized controlled trial testing the efficacy of brief motivational counseling (BMC) delivered by primary care clinicians and the added value of supplementing BMC with monthly contact by community health workers (CHW) in the prevention/reversal of obesity in Latino and Black children ages 2-4 years old. METHODS/DESIGN:Mother-child dyads (targeted n?=?150) are recruited for this 12-month randomized trial at an inner-city pediatric primary care clinic and randomized to: 1) BMC delivered by clinicians and nurses at well, sick, and WIC visits with the goal of reducing obesogenic behaviors (BMC); 2) BMC plus monthly phone calls by a CHW (BMC?+?Phone); or 3) BMC plus monthly home visits by a CHW (BMC?+?Home). During BMC, the medical team facilitates the selection of a specific goal (i.e., reduce sugar sweetened beverage consumption) that is meaningful to the mother and teaches the mother simple behavioral strategies. Monthly contacts with CHWs are designed to identify and overcome barriers to goal progress. Dyads are assessed at baseline and 12 months and the primary outcome is change in the child's BMI percentile. We hypothesize that BMC?+?Phone and BMC?+?Home will produce greater reductions in BMI percentiles than BMC alone and that BMC?+?Home will produce greater reductions in BMI percentiles than BMC?+?Phone. DISCUSSION:Steps to Growing Up Healthy will provide important information about whether a brief primary care-based intervention that utilizes a motivational interviewing and goal setting approach can be incorporated into routine care and is sufficient to prevent/reverse obesity in young children. The study will also explore whether monthly contact with a community health worker bridges the gap between the clinic and the community and is an effective strategy for promoting obesity prevention in high-risk families. TRIAL REGISTRATION:ClinicalTrials.gov NCT01973153.
| S-EPMC3933325 | biostudies-literature
Project description:BACKGROUND:Young children living in historically marginalized families are at risk for becoming adolescents with obesity and subsequently adults with increased obesity-related morbidities. These risks are particularly acute for Hispanic children. We hypothesized that the prevention-focused, socioecological approach of the "Minding the Baby" (MTB) home visiting program might decrease the rate of childhood overweight and obesity early in life. METHODS:This study is a prospective longitudinal cohort study in which we include data collected during 2 phases of the MTB randomized controlled trial. First-time, young mothers who lived in medically underserved communities were invited to participate in the MTB program. Data were collected on demographics, maternal mental health, and anthropometrics of 158 children from birth to 2 years. RESULTS:More children in the intervention group had a healthy BMI at 2 years. The rate of obesity was significantly higher (P < .01) in the control group (19.7%) compared with the intervention group (3.3%) at this age. Among Hispanic families, children in the MTB intervention were less likely to have overweight or obesity (odds ratio = 0.32; 95% confidence interval: 0.13-0.78). CONCLUSIONS:Using the MTB program, we significantly lowered the rate of obesity among 2-year-old children living in low-socioeconomic-status communities. In addition, children of Hispanic mothers were less likely to have overweight or obesity at 2 years. Given the high and disproportionate national prevalence of Hispanic young children with overweight and obesity and the increased costs of obesity-related morbidities, these findings have important clinical, research, and policy implications.
| S-EPMC5810599 | biostudies-literature
Project description:Recommendations for the prevention of childhood obesity encourage providers to counsel parents and their children on healthy diet and activity behaviors. This study evaluated the feasibility of a theory-based, tailored communication intervention for obesity prevention (Team Up for Health) delivered during a well-child visit. A two-armed randomized controlled trial was used. Parents of children aged 4-10 years were recruited from a list of patients due for a well-child visit at a pediatric primary care clinic. Parents were randomized to either the 'immediate' condition (parent and pediatrician received the tailored report at the well-child visit) or the 'delayed' condition (parent received the report at the end of the study). Self-report measures assessed physical activity, fruits, vegetables, television time, sugary drinks, and 100% fruit juice. Parents completed assessments at baseline, <48 h and 4-week follow-up. Providers were interviewed at the end of the study. Independent t-tests were used to examine between group differences. Seven areas of feasibility were evaluated: Recruitment, randomization, measurement, retention, acceptability, implementation and demand. Results showed high rates of measurement (85%) and acceptability (89%) and implementation (80%) of the intervention. In conclusion, Team Up for Health was feasible; however, a larger study is needed to evaluate its efficacy.
| S-EPMC6018684 | biostudies-literature
Project description:Pediatric primary care is an important setting in which to address obesity prevention, yet relatively few interventions have been evaluated and even fewer have been shown to be effective. The development and evaluation of cost-effective approaches to obesity prevention that leverage opportunities of direct access to families in the pediatric primary care setting, overcome barriers to implementation in busy practice settings, and facilitate sustained involvement of parents is an important public health priority. The goal of the Healthy Homes/Healthy Kids (HHHK 5-10) randomized controlled trial is to evaluate the efficacy of a relatively low-cost primary care-based obesity prevention intervention aimed at 5 to 10 year old children who are at risk for obesity. Four hundred twenty one parent/child dyads were recruited and randomized to either the obesity prevention arm or a Contact Control condition that focuses on safety and injury prevention. The HHHK 5-10 obesity prevention intervention combines brief counseling with a pediatric primary care provider during routine well child visits and follow-up telephone coaching that supports parents in making home environmental changes to support healthful eating, activity patterns, and body weight. The Contact Control condition combines the same provider counseling with telephone coaching focused on safety and injury prevention messages. This manuscript describes the study design and baseline characteristics of participants enrolled in the HHHK 5-10 trial.
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Project description:The Diabetes Prevention Program (DPP) lifestyle intervention reduced the incidence of type 2 diabetes mellitus (DM) among high-risk adults by 58%, with weight loss as the dominant predictor. However, it has not been adequately translated into primary care.We evaluated 2 adapted DPP lifestyle interventions among overweight or obese adults who were recruited from 1 primary care clinic and had pre-DM and/or metabolic syndrome. Participants were randomized to (1) a coach-led group intervention (n = 79), (2) a self-directed DVD intervention (n = 81), or (3) usual care (n = 81). During a 3-month intensive intervention phase, the DPP-based behavioral weight-loss curriculum was delivered by lifestyle coach-led small groups or home-based DVD. During the maintenance phase, participants in both interventions received lifestyle change coaching and support remotely-through secure email within an electronic health record system and the American Heart Association Heart360 website for weight and physical activity goal setting and self-monitoring. The primary outcome was change in body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) from baseline to 15 months.At baseline, participants had a mean (SD) age of 52.9 (10.6) years and a mean BMI of 32.0 (5.4); 47% were female; 78%, non-Hispanic white; and 17%, Asian/Pacific Islander. At month 15, the mean ± SE change in BMI from baseline was -2.2 ± 0.3 in the coach-led group vs -0.9 ± 0.3 in the usual care group (P < .001) and -1.6 ± 0.3 in the self-directed group vs usual care (P = .02). The percentages of participants who achieved the 7% DPP-based weight-loss goal were 37.0% (P = .003) and 35.9% (P = .004) in the coach-led and self-directed groups, respectively, vs 14.4% in the usual care group. Both interventions also achieved greater net improvements in waist circumference and fasting plasma glucose level.Proven effective in a primary care setting, the 2 DPP-based lifestyle interventions are readily scalable and exportable with potential for substantial clinical and public health impact.clinicaltrials.gov Identifier: NCT00842426.
| S-EPMC3856315 | biostudies-literature
Project description:ImportanceIntensive behavioral interventions for childhood overweight and obesity are recommended by national guidelines, but are currently offered primarily in specialty clinics. Evidence is lacking on their effectiveness in pediatric primary care settings.ObjectiveTo evaluate the effects of family-based treatment for overweight or obesity implemented in pediatric primary care on children and their parents and siblings.Design, setting, and participantsThis randomized clinical trial in 4 US settings enrolled 452 children aged 6 to 12 years with overweight or obesity, their parents, and 106 siblings. Participants were assigned to undergo family-based treatment or usual care and were followed up for 24 months. The trial was conducted from November 2017 through August 2021.InterventionsFamily-based treatment used a variety of behavioral techniques to develop healthy eating, physical activity, and parenting behaviors within families. The treatment goal was 26 sessions over a 24-month period with a coach trained in behavior change methods; the number of sessions was individualized based on family progress.Main outcomes and measuresThe primary outcome was the child's change from baseline to 24 months in the percentage above the median body mass index (BMI) in the general US population normalized for age and sex. Secondary outcomes were the changes in this measure for siblings and in BMI for parents.ResultsAmong 452 enrolled child-parent dyads, 226 were randomized to undergo family-based treatment and 226 to undergo usual care (child mean [SD] age, 9.8 [1.9] years; 53% female; mean percentage above median BMI, 59.4% [n = 27.0]; 153 [27.2%] were Black and 258 [57.1%] were White); 106 siblings were included. At 24 months, children receiving family-based treatment had better weight outcomes than those receiving usual care based on the difference in change in percentage above median BMI (-6.21% [95% CI, -10.14% to -2.29%]). Longitudinal growth models found that children, parents, and siblings undergoing family-based treatment all had outcomes superior to usual care that were evident at 6 months and maintained through 24 months (0- to 24-month changes in percentage above median BMI for family-based treatment and usual care were 0.00% [95% CI, -2.20% to 2.20%] vs 6.48% [95% CI, 4.35%-8.61%] for children; -1.05% [95% CI, -3.79% to 1.69%] vs 2.92% [95% CI, 0.58%-5.26%] for parents; and 0.03% [95% CI, -3.03% to 3.10%] vs 5.35% [95% CI, 2.70%-8.00%] for siblings).Conclusions and relevanceFamily-based treatment for childhood overweight and obesity was successfully implemented in pediatric primary care settings and led to improved weight outcomes over 24 months for children and parents. Siblings who were not directly treated also had improved weight outcomes, suggesting that this treatment may offer a novel approach for families with multiple children.Trial registrationClinicalTrials.gov Identifier: NCT02873715.
| S-EPMC10265310 | biostudies-literature
Project description:The Healthy Homes/Healthy Kids Preschool (HHHK-Preschool) pilot program is an obesity prevention intervention integrating pediatric care provider counseling and a phone-based program to prevent unhealthy weight gain among 2- to 4-year-old children at risk for obesity (BMI percentile between the 50th and 85th percentile and at least one overweight parent) or currently overweight (85th percentile ? BMI < 95th percentile). The aim of this randomized, controlled pilot study was to evaluate the feasibility, acceptability, and potential efficacy of the HHHK-Preschool intervention.Sixty parent-child dyads recruited from pediatric primary care clinics were randomized to: (1) the Busy Bodies/Better Bites Obesity Prevention Arm or the (2) Healthy Tots/Safe Spots safety/injury prevention Contact Control Arm. Baseline and 6-month data were collected, including measured height and weight, accelerometry, previous day dietary recalls, and parent surveys. Intervention process data (e.g., call completion) were also collected.High intervention completion and satisfaction rates were observed. Although a statistically significant time by treatment interaction was not observed for BMI percentile or BMI z-score, post-hoc examination of baseline weight status as a moderator of treatment outcome showed that the Busy Bodies/Better Bites obesity prevention intervention appeared to be effective among children who were in the overweight category at baseline relative to those who were categorized as at risk for obesity (p?=?0.04).HHHK-Preschool pilot study results support the feasibility, acceptability, and potential efficacy in already overweight children of a pediatric primary care-based obesity prevention intervention integrating brief provider counseling and parent-targeted phone coaching. What's New: Implementing pediatric primary care-based obesity interventions is challenging. Previous interventions have primarily involved in-person sessions, a barrier to sustained parent involvement. HHHK-preschool pilot study results suggest that integrating brief provider counseling and parent-targeted phone coaching is a promising approach.
| S-EPMC4677530 | biostudies-literature
Project description:BackgroundCardiometabolic diseases (CMD) are the major cause of death worldwide and are associated with a lower quality of life and high healthcare costs. To prevent a further rise in CMD and related healthcare costs, early detection and adequate management of individuals at risk could be an effective preventive strategy. The objective of this study was to determine long-term cost-effectiveness of stepwise CMD risk assessment followed by individualized treatment if indicated compared to care as usual. A computer-based simulation model was used to project long-term health benefits and cost-effectiveness, assuming the prevention program was implemented in Dutch primary care.MethodsA randomized controlled trial in a primary care setting in which 1934 participants aged 45-70 years without recorded CMD or CMD risk factors participated. The intervention group was invited for stepwise CMD risk assessment through a risk score (step 1), additional risk assessment at the practice in case of increased risk (step 2) and individualized follow-up treatment if indicated (step 3). The control group was not invited for risk assessment, but completed a health questionnaire. Results of the effectiveness analysis on systolic blood pressure (- 2.26 mmHg; 95% CI - 4.01: - 0.51) and total cholesterol (- 0.15 mmol/l; 95% CI - 0.23: - 0.07) were used in this analysis. Outcome measures were the costs and benefits after 1-year follow-up and long-term (60 years) cost-effectiveness of stepwise CMD risk assessment compared to no assessment. A computer-based simulation model was used that included data on disability weights associated with age and disease outcomes related to CMD. Analyses were performed taking a healthcare perspective.ResultsAfter 1 year, the average costs in the intervention group were 260 Euro higher than in the control group and differences were mainly driven by healthcare costs. No meaningful change was found in EQ 5D-based quality of life between the intervention and control groups after 1-year follow-up (- 0.0154; 95% CI - 0.029: 0.004). After 60 years, cumulative costs of the intervention were 41.4 million Euro and 135 quality-adjusted life years (QALY) were gained. Despite improvements in blood pressure and cholesterol, the intervention was not cost-effective (ICER of 306,000 Euro/QALY after 60 years). Scenario analyses did not allow for a change in conclusions with regard to cost-effectiveness of the intervention.ConclusionsImplementation of this primary care-based CMD prevention program is not cost-effective in the long term. Implementation of this program in primary care cannot be recommended.Trial registrationDutch Trial Register NTR4277 , registered on 26 November 2013.
| S-EPMC7948329 | biostudies-literature