Efficacy and safety of lowering dietary intake of total fat, saturated fat, and cholesterol in children with elevated LDL cholesterol: the Dietary Intervention Study in Children.

BACKGROUND: Few studies have shown the efficacy and safety of lower-fat diets in children. OBJECTIVE: Our objective was to assess the efficacy and safety of lowering dietary intake of total fat, saturated fat, and cholesterol to decrease LDL-cholesterol concentrations in children. DESIGN: A 6-center, randomized controlled clinical trial was carried out in 663 children aged 8-10 y with LDL-cholesterol concentrations greater than the 80th and less than the 98th percentiles for age and sex. The children were randomly assigned to either an intervention group or a usual care group. Behavioral intervention promoted adherence to a diet providing 28% of energy from total fat, <8% from saturated fat,

Maternal acceptability of a dietary intervention designed to lower children's intake of saturated fat and cholesterol: the Dietary Intervention Study in Children (DISC).

OBJECTIVE: This report examined the acceptability to mothers of a dietary educational and behavioral intervention for preadolescent children with elevated levels of serum low-density lipoprotein cholesterol (LDL-C) who were enrolled in the Dietary Intervention Study in Children (DISC). DESIGN: DISC is a randomized, controlled clinical trial. Subjects were randomly assigned to either an intervention or usual-care (control) group. SUBJECTS/SETTING: To be eligible for the study, participants were required to have the average of 2 fasting LDL-C values fall between the 80th and 98th sex-specific percentiles. Three hundred thirty-four 8-to 10-year-old children and their families were randomly assigned to an intervention group, and 329 were assigned to a usual-care (control) group. This study examined data from 232 subjects in the intervention group. Data were collected at 6 intervention sites around the United States. INTERVENTION: Those assigned to the intervention group participated in a multidisciplinary dietary intervention that included a series of group and individual sessions over a 3-year period. Children and their caretakers were taught to follow a nutritionally adequate diet that was low in total fat, saturated fat, and cholesterol and high in polyunsaturated fat. MAIN OUTCOME MEASURES: Three nonconsecutive 24-hour diet recalls were collected at baseline and at 1 year by trained and certified dietitians. A questionnaire designed to assess diet acceptability was administered at months 4, 8, 11, and 15. Demographic measures were collected at the onset of the study. STATISTICAL ANALYSIS PERFORMED: Statistical procedures included factor analysis and regression analysis. RESULTS: Regression analysis suggested that perceived effectiveness of the dietary intervention and mothers' having few concerns about disadvantages of the diet were significantly related to higher overall fat intake in children in one-parent families. Maternal willingness to implement the diet was significantly related to lower saturated fat intake. APPLICATIONS/CONCLUSIONS: In attempts to change eating behavior of children, interest and cooperation of the parents are essential to achieving successful results. These analyses further suggest that maternal acceptability translates into willingness to implement the diet and may facilitate changes that are associated with reduced saturated fat intake in children.

Effects of diet and sexual maturation on low-density lipoprotein cholesterol during puberty: the Dietary Intervention Study in Children (DISC).

BACKGROUND: The Dietary Intervention Study in Children (DISC) is a multicenter, randomized, controlled clinical trial designed to examine the efficacy and safety of a dietary intervention to reduce serum LDL cholesterol (LDL-C) in children with elevated LDL-C. METHODS AND RESULTS: The effects of dietary intake of fat and cholesterol and of sexual maturation and body mass index (BMI) on LDL-C were examined in a 3-year longitudinal study of 663 boys and girls (age 8 to 10 years at baseline) with elevated LDL-C levels. Multiple linear regression was used to predict LDL-C at 3 years. For boys, LDL-C decreased by 0.018 mmol/L for each 10 mg/4.2 MJ decrease in dietary cholesterol (P<.05). For girls, no single nutrient was significant in the model, but a treatment group effect was evident (P<.05). In both sexes, BMI at 3 years and LDL-C at baseline were significant and positive predictors of LDL-C levels. In boys, the average LDL-C level was 0.603 mmol/L lower at Tanner stage 4+ than at Tanner stage 1 (P<.01). In girls, the average LDL-C level was 0.274 mmol/L lower at Tanner stage 4+ than at Tanner stage 1 (P<.05). CONCLUSIONS: In pubertal children, sexual maturation, BMI, dietary intervention (in girls), and dietary cholesterol (in boys) were significant in determining LDL-C. Sexual maturation was the factor associated with the greatest difference in LDL-C. Clinicians screening for dyslipidemia or following dyslipidemic children should be aware of the powerful effects of pubertal change on measurements of lipoproteins.

The Dietary Intervention Study in Children (DISC): dietary assessment methods for 8- to 10-year-olds.

OBJECTIVES: The dietary assessment methods used in the Dietary Intervention Study in Children (DISC) are described and the rationale, validity, and/or general usefulness of each are discussed. DESIGN: DISC is the first multicenter, randomized, clinical trial to study the feasibility and long-term efficacy, safety, and acceptability of a fat-moderately diet in 8- to 10-year-old prepubescent children with moderately elevated plasma low-density lipoprotein cholesterol (LDL-C) levels. Final data collection for the original study (DISC I) occurred December 1, 1993; continued intervention and follow-up (DISC II) will extend beyond 1997. SETTING: Six clinical centers across the country participate in DISC. SUBJECTS: Preadolescent boys and girls with fasting LDL-C levels between the 80th and 98th age-specific and sex-specific percentiles established by the Lipid Research Clinics were eligible for the study. The feasibility phase included 140 children who were then enveloped into the full-scale trial. Baseline dietary data for 652 randomized children in the full-scale trial and 6-month results for the feasibility cohort are reported. INTERVENTIONS: Dietary assessment involved several elements: (a) determining eligibility based on consumption of more than 30% of energy from total fat, (b) monitoring adherence to and adequacy of the intervention diet, (c) evaluating acceptability of the diet in the intervention group, and (d) determining appropriate foods for the intervention diet. Methods are described for each purpose. MAIN OUTCOME MEASURES: LDL-C differences between the two groups and differences in total and saturated fat intakes as calculated from three 24-hour recalls were the primary outcome measures. Six-month dietary differences in the feasibility group are reported. STATISTICAL METHODS: Baseline group means and 6-month differences in dietary intake are reported for the full-scale trial and feasibility study, respectively. RESULTS: Baseline mean intake from three dietary recalls for the intervention (n = 328) and control (n = 324) groups, respectively, were as follows: energy = 1,759 kcal and 1,728 kcal; total energy from fat = 33.3% and 34.0%; total energy from saturated fat = 12.5% and 12.7%; and total dietary cholesterol = 209 mg and 195 mg. After 6 months of intervention, percentage of energy from total fat and saturated fat was reduced by 5.1% (P = .004) and 2.9% (P < .001), respectively, in this feasibility subset (n = 73) of the intervention group. Essentially no change in these parameters occurred in the control group (n = 67), which demonstrates a measurable difference in reporting between groups. APPLICATIONS/CONCLUSIONS: Results illustrate the feasibility of implementing a variety of dietary assessment methods among preadolescent children without relying primarily on parental reports.