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Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial.

ABSTRACT: OBJECTIVE:To test the effect on diabetes management outcomes of a low-intensity, clinic-integrated behavioral intervention for families of youth with type 1 diabetes. METHODS:Families (n = 390) obtaining care for type 1 diabetes participated in a 2-year randomized clinical trial of a clinic-integrated behavioral intervention designed to improve family diabetes management practices. Measurement of hemoglobin A1c, the primary outcome, was obtained at each clinic visit and analyzed centrally. Blood glucose meter data were downloaded at each visit. Adherence was assessed by using a semistructured interview at baseline, mid-study, and follow-up. Analyses included 2-sample t tests at predefined time intervals and mixed-effect linear-quadratic models to assess for difference in change in outcomes across the study duration. RESULTS:A significant overall intervention effect on change in glycemic control from baseline was observed at the 24-month interval (P = .03). The mixed-effect model showed a significant intervention by age interaction (P < .001). Among participants aged 12 to 14, a significant effect on glycemic control was observed (P = .009 for change from baseline to 24-month interval; P = .035 for mixed-effect model across study duration), but there was no effect among those aged 9 to 11. There was no intervention effect on child or parent report of adherence; however, associations of change in adherence with change in glycemic control were weak. CONCLUSIONS:This clinic-integrated behavioral intervention was effective in preventing the deterioration in glycemic control evident during adolescence, offering a potential model for integrating medical and behavioral sciences in clinical care.

SUBMITTER: Nansel TR

PROVIDER: S-EPMC3313642 | biostudies-literature | 2012 Apr

REPOSITORIES: biostudies-literature

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Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial.

Nansel Tonja R TR Iannotti Ronald J RJ Liu Aiyi A

Pediatrics 20120305 4

<h4>Objective</h4>To test the effect on diabetes management outcomes of a low-intensity, clinic-integrated behavioral intervention for families of youth with type 1 diabetes.<h4>Methods</h4>Families (n = 390) obtaining care for type 1 diabetes participated in a 2-year randomized clinical trial of a clinic-integrated behavioral intervention designed to improve family diabetes management practices. Measurement of hemoglobin A1c, the primary outcome, was obtained at each clinic visit and analyzed c ...[more]

PMID: 22392172

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Project description:BACKGROUND:Children who are picky eaters typically demonstrate persistent food refusal and poor diet quality and may be resistant to intervention. OBJECTIVE:This study tested whether pickiness moderated the effect of a nutrition intervention on diet quality in youth with type 1 diabetes, hypothesizing that the intervention effect would be smaller among picky relative to nonpicky eaters. DESIGN:The study was an 18-month randomized clinical trial. PARTICIPANTS:Youth age 8.0 to 16.9 years (n=136) with type 1 diabetes duration ?1 year, receiving care at an outpatient diabetes center in Boston, MA, and a parent, participated from 2010 to 2013. INTERVENTION:The intervention integrated motivational interviewing, active learning, and applied problem solving to increase whole plant food intake. MAIN OUTCOME MEASURES:Whole plant food density (WPFD, cup/oz equivalents per 1,000 kcal target food groups), Healthy Eating Index-2005 (HEI2005, measures conformance to US dietary guidelines), and dietary variety were calculated from 3-day food records completed at six different times. Parents completed the pickiness subscale of the Child Feeding Questionnaire. STATISTICAL ANALYSES PERFORMED:Mean WPFD and HEI2005 were estimated using the population ratio method; standard errors were computed using jackknife variance-covariance estimation. Overall P value comparing groups across visits was derived using the ?2 test. RESULTS:Baseline diet quality was lower in picky than in nonpicky eaters. No intervention effect on pickiness or dietary variety was seen. In stratified analyses, the intervention effect on diet quality was significant for picky eaters only (WPFD P=0.0003; HEI2005 P=0.04). Among picky eaters, diet quality in the treatment group improved, whereas diet quality in the control group remained low. Diet quality of nonpicky eaters in the intervention group changed to a lesser degree. CONCLUSIONS:The intervention resulted in increased diet quality in picky eaters, whereas no intervention effect was seen in nonpicky eaters. Findings suggest that diet quality of picky eaters can be improved without changing their underlying pickiness.

Project description:BackgroundDiets of children with type 1 diabetes are low in fruits, vegetables, and whole grains, and high in foods of minimal nutritional value, increasing risk for future adverse health outcomes. This 18-month randomized clinical trial tested the effect of a family-based behavioral intervention integrating motivational interviewing, active learning, and applied problem-solving on the primary outcomes of dietary intake and glycemic control among youth with type 1 diabetes.MethodsA parallel-group study with equal randomization was conducted at an outpatient, free-standing, multidisciplinary tertiary diabetes center in the United States. Eligible youth were those age 8-16 years with type 1 diabetes diagnosis ≥1 year and hemoglobin A1c (HbA1c) ≥6.5% and ≤10.0%. Participants were 136 parent-youth dyads (treatment n = 66, control n = 70). The intervention consisted of 9 in-clinic sessions delivered to the child and parent; control condition comprised equivalent assessments and number of contacts without dietary advice. Dietary intake was assessed using 3-day diet records at 6 time points across the 18-month study. Dietary outcomes included the Healthy Eating Index-2005 (HEI2005; index measuring conformance to the 2005 United States Dietary Guidelines for Americans) and Whole Plant Food Density (WPFD; number of cup or ounce equivalents per 1000 kcal of whole grains, whole fruit, vegetables, legumes, nuts, and seeds consumed). HbA1c was obtained every 3 months. Overall comparison of outcome variables between intervention and usual care groups was conducted using permutation tests.ResultsThere was a positive intervention effect across the study duration for HEI2005 (p = .015) and WPFD (p = .004). At 18 months, HEI2005 was 7.2 greater (mean ± SE 64.6 ± 2.0 versus 57.4 ± 1.6), and WPFD was 0.5 greater (2.2 ± 0.1 versus 1.7 ± 0.1) in the intervention group versus control. There was no difference between groups in HbA1c across the study duration.ConclusionsThis behavioral nutrition intervention improved dietary quality among youth with type 1 diabetes, but did not impact glycemic control. Findings indicate the potential utility of incorporating such strategies into clinical care, and suggest that improvement in diet quality can be achieved in families living with this burdensome disease.Trial registrationClinicaltrials.gov registration number: NCT00999375.

Project description:BackgroundParent-child diet quality resemblance is unknown in families of youth with type 1 diabetes, for whom nutrition is central to disease management.ObjectiveExamine diet quality resemblance in families of youth with type 1 diabetes participating in a behavioral nutrition intervention trial and investigate whether treatment assignment or family meal frequency modifies resemblance.DesignThis is a secondary data analysis from an 18-month randomized controlled trial conducted August 2010 to May 2013.Participants/settingParent-youth dyads (N=136, child age=12.3±2.5 years) were recruited from a northeast US diabetes center.Main outcome measuresParent and child Healthy Eating Index-2005 (HEI-2005, reflecting adherence to 2005 Dietary Guidelines for Americans) and whole plant food density (WPFD, reflecting intervention target foods) were calculated from 3-day food records collected every 6 months.Statistical analysisLinear random effects models adjusting for demographics and disease characteristics investigated parent-child diet quality resemblance. Separate models examined whether treatment assignment or family meal frequency modified resemblance. Three-way interaction terms examined whether resemblance changed over time by treatment assignment.ResultsTime-varying parent and child HEI-2005 and WPFD were positively associated (P<0.001), and there were no interactions with family meals. Parent-child HEI-2005 resemblance was similar across treatment groups; however, parent-child WPFD resemblance was stronger in the intervention (β±standard error [SE]=.30±.06) vs control families (β±SE=.12±.05). Parent-child HEI-2005 resemblance was similar over time by treatment assignment, whereas parent-child WPFD resemblance increased over time for families in the intervention group (three-way interaction term β±SE=.03±.01).ConclusionsParent and youth diet quality were positively correlated in families of youth with type 1 diabetes. Resemblance was stronger in the intervention group for target foods, but not for a general measure of diet quality. The lack of effect modification by family meal frequency suggests that family diet quality resemblance is not contingent on shared meals.

Project description:Youth in war-affected regions are at risk for poor psychological, social, and educational outcomes. Effective interventions are needed to improve mental health, social behavior, and school functioning. This randomized controlled trial tested the effectiveness of a 10-session cognitive-behavioral therapy (CBT)-based group mental health intervention for multisymptomatic war-affected youth (aged 15-24 years) in Sierra Leone.War-affected youth identified by elevated distress and impairment via community screening were randomized (stratified by sex and age) to the Youth Readiness Intervention (YRI) (n = 222) or to a control condition (n = 214). After treatment, youth were again randomized and offered an education subsidy immediately (n = 220) or waitlisted (n = 216). Emotion regulation, psychological distress, prosocial attitudes/behaviors, social support, functional impairment, and posttraumatic stress disorder (PTSD) symptoms were assessed at pre- and postintervention and at 6-month follow-up. For youth in school, enrollment, attendance, and classroom performance were assessed after 8 months. Linear mixed-effects regressions evaluated outcomes.The YRI showed significant postintervention effects on emotion regulation, prosocial attitudes/behaviors, social support, and reduced functional impairment, and significant follow-up effects on school enrollment, school attendance, and classroom behavior. In contrast, education subsidy was associated with better attendance but had no effect on mental health or functioning, school retention, or classroom behavior. Interactions between education subsidy and YRI were not significant.YRI produced acute improvements in mental health and functioning as well as longer-term effects on school engagement and behavior, suggesting potential to prepare war-affected youth for educational and other opportunities. Clinical trial registration information-Trial of the Youth Readiness Intervention (YRI); http://clinicaltrials.gov; NCT01684488.

Project description:BackgroundDiabetes disproportionately affects African Americans and is associated with poorer outcomes. Self-management is important for glycemic control; however, evidence in African Americans is limited.ObjectiveTo assess the efficacy of a combined telephone-delivered education and behavioral skills intervention (TBSI) in reducing hemoglobin A1c (HbA1c) levels in African Americans with type 2 diabetes, using a factorial design.DesignThis is a four-year randomized clinical trial, using a 2 x 2 factorial design.: Participants: African American adults ≥18 years) with poorly controlled type 2 diabetes (HbA1c ≥9%) were randomly assigned to one of four groups: 1) knowledge only, 2) skills only, 3) combined knowledge and skills (TBSI), or 4) control group.InterventionAll participants received 12 telephone-delivered 30-min intervention sessions specific to their assigned group. Participants were assessed at baseline and 3, 6, and 12 months.Main measureThe primary outcome was HbA1c at 12 months post-randomization in the intent-to-treat (ITT) population.Key resultsTwo hundred fifty-five participants were randomly assigned to the four groups. Based on the ITT population after multiple imputation, the analysis of covariance with baseline HbA1c as the covariate showed that HbA1c at 12 months for the intervention groups did not differ significantly from that of the control group (knowledge: 0.49, p = 0.123; skills: 0.23, p = 0.456; combined: 0.48, p = 0.105). Absolute change from baseline at 12 months for all treatment arms was 0.6. Longitudinal mixed effects analysis showed that, on average, there was a significant decline in HbA1c over time for all treatment groups (-0.07, p < 0.001). However, the rates of decline for the intervention groups were not significantly different from that of the control group (knowledge: 0.06, p = 0.052; skills: 0.02, p = 0.448; combined: 0.05, p = 0.062). Results from per-protocol populations were similar.ConclusionsFor African Americans with poorly controlled type 2 diabetes, combined education and skills training did not achieve greater reductions in glycemic control (i.e., HbA1c levels) at 12 months compared to the control group, education alone, or skills training alone. This trial is registered with ClinicalTrials.gov, identifier no. NCT00929838.

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Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial.

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Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial.

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