BackgroundFew interventions have shown efficacy to influence key energy balance behaviors during the preschool years.ObjectiveA randomized controlled trial (RCT) was used to evaluate the efficacy of Food, Fun, and Families (FFF), a 12 week authoritative food parenting intervention for mothers with low-income levels, to reduce preschool-aged children’s intake of calories from solid fat and added sugar (SoFAS).MethodsMothers were randomly assigned to receive FFF (n = 59) or to a delayed treatment control (n = 60). The primary outcome was children’s daily energy intake from SoFAS at the end of the 12 week intervention, controlling for baseline levels, assessed by 24-h dietary recalls. Secondary outcomes included children’s daily energy intake, children’s BMI z-scores, and meal observations of maternal food parenting practices targeted in FFF (e.g. providing guided choices).ResultsParticipating mothers were predominantly African American (91%), with 39% educated beyond high school and 66% unemployed. Baseline demographics and child SoFAS intakes did not differ by group. Lost to follow-up was 13% and did not differ between groups. At post-intervention, FFF children consumed ~ 94 kcal or 23% less daily energy from SoFAS than children in the control group, adjusting for baseline levels (307.8 (95%CI = 274.1, 341.5) kcal vs. 401.9 (95%CI = 369.8, 433.9) kcal, FFF vs. control; p < 0.001). FFF mothers also displayed a greater number of authoritative parenting practices when observed post-intervention with their child at a buffet-style meal (Wilcoxon z = − 2.54, p = 0.012). Neither child total daily energy intake nor BMI z-scores differed between groups post-intervention.ConclusionsFindings demonstrate the initial efficacy of an authoritative food parenting intervention for families with low-income to reduce SoFAS intake in early childhood. Additional research is needed to evaluate longer-term effects on diet and growth.Trial registrationRetrospectively registered at ClinicalTrials.gov: #NCT03646201.
The results of this study indicate that the Test Product significantly reduced corneal and conjunctival staining, indicating a reduction in disease severity. Evaluations of ocular staining scores provide clinically meaningful evidence of dry eye severity and are an important indicator of dry eye disease progression.
BackgroundThe purpose of this study was to compare changes in corneal staining in patients with dry eye after 6 weeks of treatment with Systane® Gel Drops or Refresh Liquigel® lubricant eye drops.MethodsPatients aged ≥18 years with a sodium fluorescein corneal staining sum score of ≥3 in either eye and best-corrected visual acuity of 0.6 logarithm of the minimum angle of resolution or better in each eye who were using a lubricant eye gel or ointment for dry eye were included in this randomized, parallel-group, multicenter, double-blind trial. Patients were randomized to four times daily Systane® Gel Drops (polyethylene glycol 400 0.4% and propylene glycol 0.3%) or Refresh LiquiGel® Drops (carboxymethylcellulose sodium 1%) for 6 weeks. The primary efficacy outcome was mean change from baseline to week 6 in sodium fluorescein corneal staining. Supportive efficacy outcomes included conjunctival staining, tear film break-up time, Patient Global Assessment of Improvement, Impact of Dry Eye on Everyday Life (IDEEL) Treatment Satisfaction/Treatment Bother Questionnaire, Single Symptom Comfort Scale, and Ocular Symptoms Questionnaire. The safety analysis comprised recording of adverse events.ResultsIn total, 147 patients (Systane group, n=73; Refresh group, n=74; mean ± standard deviation age, 57±16 years) were enrolled and included in the safety and efficacy analyses. Corneal staining was significantly reduced from baseline to week 6 for Systane and Refresh (−3.4±2.5 and −2.5±2.6 units, respectively; P<0.0001, t-test), with a significantly greater improvement with Systane versus Refresh (P=0.0294). Results for conjunctival staining, tear film break-up time, and patient-reported outcome questionnaires were not statistically different between groups. No safety issues were identified; adverse events were reported by 19% of patients with Systane and 30% of patients with Refresh eye drops.ConclusionSystane Gel Drops were associated with significantly better corneal staining scores versus Refresh Liquigel eye drops in patients with dry eye. Supportive efficacy outcomes were not significantly different between groups. Both treatments were well tolerated.
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