CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
RESEARCH SUPPORT, U.S. GOV'T, P.H.S.
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High-soluble-fiber foods in conjunction with a telephone-based, personalized behavior change support service result in favorable changes in lipids and lifestyles after 7 weeks.

OBJECTIVE: To evaluate whether an intervention of foods high in soluble fiber from psyllium and/or oats plus a telephone-based, personalized behavior change support service improves serum lipids and elicits cholesterol-managing lifestyle changes vs usual care.

DESIGN: 7-week randomized, controlled intervention.

SUBJECTS/SETTING: 150 moderately hypercholesterolemic men and women, age range 25 to 70 years.

INTERVENTION: The intervention group consumed 4 servings/day of high-fiber foods and had weekly telephone conversations with a personal coach who offered support and guidance in making lifestyle changes consistent with the National Cholesterol Education Program's (NCEP) cholesterol-lowering guidelines. The usual care group received a handout describing the NCEP Step-1 diet.

MAIN OUTCOME MEASURES: Serum lipids and lipoproteins and self-reported lifestyle changes.

STATISTICAL ANALYSES: For physiologic and dietary changes, mixed linear models for repeated measures were applied. Models were simplified using analysis of covariance where age in years was the covariate. Traditional general linear models were used to assess lifestyle changes.

RESULTS: In the intervention group total cholesterol (TC) decreased 5.6%, low-density lipoprotein (LDL) cholesterol 7.1%, LDL/high-density lipoprotein (HDL) cholesterol ratio 5.6%, and triglycerides (TG) 14.2% (P<.0167); decreases in TC and LDL were significantly different from the usual care group. In the usual care group TC decreased 1.9%, LDL 1.2%, LDL/HDL 1.9%, and TG 4.4% (all not significant). The intervention group also reported an increase in their knowledge, ability, and confidence to make cholesterol-managing diet and exercise changes compared with the usual care group (P<.05). The intervention group had a greater decrease in energy intake from saturated fat (-1.6%) and increase in soluble fiber intake (7.3%) than the usual care group (P<.05). The intervention group reported an increase in exercise vs the usual care group (P<.05). Both intervention and control groups had a minimal reduction (<1%) in body weight compared with baseline (P<.0167).

APPLICATIONS/CONCLUSIONS: A 7-week intervention that includes both functional foods and individualized, interactive support for behavior change could be an effective model for dietitians to use with patients at risk for CVD, pending results of long-term studies.

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