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Randomized clinical trial of behavioral intervention and nutrition education to improve caloric intake and weight in children with cystic fibrosis.

ABSTRACT: To evaluate the efficacy of a behavioral plus nutrition education intervention, Be In CHARGE!, compared with that of a nutrition education intervention alone on caloric intake and weight gain in children with cystic fibrosis and pancreatic insufficiency.Randomized controlled trial.Cystic fibrosis centers in the eastern, midwestern, and southern United States.Seventy-nine children aged 4 to 12 years below the 40th percentile for weight for age were recruited. Sixty-seven completed the intervention and 59 completed a 24-month follow-up assessment.Comparison of a behavioral plus nutrition education intervention with a nutrition education intervention alone.Primary outcomes were changes from pretreatment to posttreatment in caloric intake and weight gain. Secondary outcomes were changes from pretreatment to posttreatment in percentage of the estimated energy requirement and body mass index z score. These outcomes were also examined 24 months posttreatment.After treatment, the behavioral plus nutrition education intervention as compared with the nutrition education intervention alone had a statistically greater average increase on the primary and secondary outcomes of caloric intake (mean, 872 vs 489 cal/d, respectively), percentage of the estimated energy requirement (mean, 148% vs 127%, respectively), weight gain (mean, 1.47 vs 0.92 kg, respectively), and body mass index z score (0.38 vs 0.18, respectively). At the 24-month follow-up, children in both conditions maintained an estimated energy requirement of around 120% and did not significantly differ on any outcomes.A behavioral plus nutrition education intervention was more effective than a nutrition education intervention alone at increasing dietary intake and weight over a 9-week period. However, across the 24-month follow-up, both treatments achieved similar outcomes. Trial Registration clinicaltrials.gov Identifier: NCT00006169.

SUBMITTER: Stark LJ

PROVIDER: S-EPMC2811078 | biostudies-literature | 2009 Oct

REPOSITORIES: biostudies-literature

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Randomized clinical trial of behavioral intervention and nutrition education to improve caloric intake and weight in children with cystic fibrosis.

Stark Lori J LJ Quittner Alexandra L AL Powers Scott W SW Opipari-Arrigan Lisa L Bean Judy A JA Duggan Christopher C Stallings Virginia A VA

Archives of pediatrics & adolescent medicine 20091001 10

<h4>Objective</h4>To evaluate the efficacy of a behavioral plus nutrition education intervention, Be In CHARGE!, compared with that of a nutrition education intervention alone on caloric intake and weight gain in children with cystic fibrosis and pancreatic insufficiency.<h4>Design</h4>Randomized controlled trial.<h4>Setting</h4>Cystic fibrosis centers in the eastern, midwestern, and southern United States.<h4>Participants</h4>Seventy-nine children aged 4 to 12 years below the 40th percentile fo ...[more]

PMID: 19805710

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Project description:Well-designed research trials are critical for determining the efficacy and effectiveness of nutrition education interventions. To determine whether behavioral and/or cognition changes can be attributed to an intervention, the experimental design must include a control or comparison condition against which outcomes from the experimental group can be compared. Despite the impact different types of control groups can have on study outcomes, the treatment provided to participants in the control condition has received limited attention in the literature.A systematic review of control groups in nutrition education interventions was conducted to better understand how control conditions are described in peer-reviewed journal articles compared with experimental conditions. To be included in the systematic review, articles had to be indexed in CINAHL, PubMed, PsycINFO, WoS, and/or ERIC and report primary research findings of controlled nutrition education intervention trials conducted in the United States with free-living consumer populations and published in English between January 2005 and December 2015. Key elements extracted during data collection included treatment provided to the experimental and control groups (e.g., overall intervention content, tailoring methods, delivery mode, format, duration, setting, and session descriptions, and procedures for standardizing, fidelity of implementation, and blinding); rationale for control group type selected; sample size and attrition; and theoretical foundation.The search yielded 43 publications; about one-third of these had an inactive control condition, which is considered a weak study design. Nearly two-thirds of reviewed studies had an active control condition considered a stronger research design; however, many failed to report one or more key elements of the intervention, especially for the control condition. None of the experimental and control group treatments were sufficiently detailed to permit replication of the nutrition education interventions studied.Findings advocate for improved intervention study design and more complete reporting of nutrition education interventions.

Project description:BACKGROUND:Nutrition interventions typically rely on self-reported intake that may be susceptible to differential reporting bias due to exposure to the intervention. Such differences may result from increased social desirability, increased attention to eating or improved recall accuracy, and may bias estimates of the intervention effect. This study investigated differential reporting bias of fruit and vegetable intake in youth with type 1 diabetes participating in a randomized controlled trial targeting increased whole plant food intake. METHODS:Participants (treatment n = 66, control n = 70) completed 3-day food records at baseline, 6-,12-, and 18-months, from which fruit and vegetable intake (servings/day) was calculated. Serum carotenoids were assessed at these visits using a high-performance liquid chromatography-based assay. Linear regression estimated associations of fruit and vegetable intake with serum carotenoids by treatment assignment. Multiplicative interaction terms tested the interaction of treatment assignment with fruit and vegetable intake on serum carotenoids for each visit and within each group over time. RESULTS:The association of fruit and vegetable intake with serum carotenoids was significantly lower in the control versus intervention group at baseline (β = 0.22 Vs 0.46) and 6-month visits (β = 0.37 Vs 0.54), as evidenced by significant interaction effects. However, the association of fruit and vegetable intake with serum carotenoids did not significantly differ over time for either group. CONCLUSIONS:While the stronger association of fruit and vegetable with carotenoids in the treatment arm suggests greater reporting accuracy, this difference was evident at baseline, and did not change significantly over time in either group. Thus, results indicate greater subject-specific bias in the control arm compared to the treatment, and lack of evidence for reactivity to the intervention by treatment assignment. CLINICAL TRIAL REGISTRY NUMBER AND WEBSITE:NCT00999375.

Project description:ImportancePersonalized interventions that leverage workplace data and environments could improve effectiveness, sustainability, and scalability of employee wellness programs.ObjectiveTo test an automated behavioral intervention to prevent weight gain and improve diet using employee cafeteria purchasing data.Design, setting, and participantsThis individual-level randomized clinical trial of a 12-month intervention with 12 months of follow-up was conducted among employees of a hospital in Boston, Massachusetts, who purchased food at on-site cafeterias that used traffic-light labels (ie, green indicates healthy; yellow, less healthy; red, unhealthy). Participants were enrolled September 2016 to February 2018. Data were analyzed from May to September 2020.InterventionsFor 12 months, participants in the intervention group received 2 emails per week with feedback on previous cafeteria purchases and personalized health and lifestyle tips and 1 letter per month with peer comparisons and financial incentives for healthier purchases. Emails and letters were automatically generated using survey, health, and cafeteria data. Control group participants received 1 letter per month with general healthy lifestyle information.Main outcomes and measuresThe main outcome was change in weight from baseline to 12 months and 24 months of follow-up. Secondary outcomes included changes in cafeteria purchases, including proportion of green- and red-labeled purchases and calories purchased per day, from baseline (12 months preintervention) to the intervention (months 1-12) and follow-up (months 13-24) periods. Baseline Healthy Eating Index-15 (HEI-15) scores were compared to HEI-15 scores at 6, 12, and 24 months.ResultsAmong 602 employees enrolled (mean [SD] age, 43.6 [12.2] years; 478 [79.4%] women), 299 were randomized to the intervention group and 303 were randomized to the control group. Baseline mean (SD) body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) was 28.3 (6.6) and HEI-15 score was 60.4 (12.4). There were no between-group differences in weight change at 12 (0.2 [95% CI, -0.6 to 1.0] kg) or 24 (0.6 [95% CI, -0.3 to 1.4] kg) months. Compared with baseline, the intervention group increased green-labeled purchases by 7.3% (95% CI, 5.4% to 9.3%) and decreased red-labeled purchases by 3.9% (95% CI, -5.0% to -2.7%) and calories purchased per day by 49.5 (95% CI, -75.2 to -23.9) kcal more than the control group during the intervention period. In the intervention group, differences in changes in green (4.8% [95% CI, 2.9% to 6.8%]) and red purchases (-3.1% [95% CI, -4.3% to -2.0%]) were sustained at the 24-month follow-up. Differences in changes in HEI-15 scores were not significantly different in the intervention compared with the control group at 6 (2.2 [95% CI, 0 to 4.4]), 12 (1.8 [95% CI, -0.6 to 4.1]), and 24 (1.6, 95% CI, -0.7 to 3.8]) months.Conclusions and relevanceThe findings of this randomized clinical trial suggest that an automated behavioral intervention using workplace cafeteria data improved employees' food choices but did not prevent weight gain over 2 years.Trial registrationClinicalTrials.gov Identifier: NCT02660086.

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Randomized clinical trial of behavioral intervention and nutrition education to improve caloric intake and weight in children with cystic fibrosis.

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Randomized clinical trial of behavioral intervention and nutrition education to improve caloric intake and weight in children with cystic fibrosis.

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