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J Acad Nutr Diet. 2016 Feb;116(2):259-71. doi: 10.1016/j.jand.2015.07.016. Epub 2015 Sep 16.

Low-Fat Dietary Pattern Intervention and Health-Related Quality of Life: The Women's Health Initiative Randomized Controlled Dietary Modification Trial.

Abstract

BACKGROUND:

Intensive dietary intervention programs may lead to benefits in vitality and other components of health quality. The Women's Health Initiative Dietary Modification (DM) intervention includes a large randomized controlled trial of an intensive intervention.

OBJECTIVE:

To evaluate whether the intervention is associated with improved health-related quality of life (HRQoL) subscales, overall self-reported health, depression symptoms, cognitive functioning, and sleep quality.

DESIGN:

This randomized controlled trial was analyzed as intent to treat.

PARTICIPANTS:

Between 1993 and 1998, 48,835 women aged 50 to 79 years were recruited by 40 clinical centers across the United States. Eligibility included having fat intake at baseline ≥32% of total calories, and excluded women with any prior colorectal or breast cancer, recent other cancers, type 1 diabetes, or medical conditions with predicted survival <3 years.

INTERVENTION:

Goals were to reduce calories from fat to 20%, increase vegetables and fruit to 5+ servings, and increase grain servings to 6+ servings a day. During the first year, 18 group sessions were held, with quarterly sessions thereafter.

MAIN OUTCOME MEASURES:

The RAND 36-Item Health Survey was used to assess HRQoL at baseline, Year 1, and close-out (about 8 years postrandomization), and estimate differential HRQoL subscale change scores.

STATISTICAL ANALYSES PERFORMED:

Mean change in HRQoL scores (Year 1 minus baseline) were compared by randomization group using linear models.

RESULTS:

At 1 year, there was a differential change between intervention and comparison group of 1.7 units (95% CI 1.5, 2.0) in general health associated with the intervention. DM intervention improved physical functioning by 2.0 units (95% CI 1.7, 2.3), vitality by 1.9 units (95% CI 1.6, 2.2), and global quality of life by 0.09 units (95% CI 0.07, 0.12). With the exception of global quality of life, these effects were significantly modified by body mass index at baseline.

CONCLUSIONS:

DM intervention was associated with small, but significant improvements in three HRQoL subscales: general health, physical functioning, and vitality at 1 year follow-up, with the largest improvements seen in the women with the greatest baseline body mass index.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00000611.

KEYWORDS:

Body mass index; Dietary intervention; Health-related-quality of life; Postmenopausal; Randomized controlled trial

PMID:
26384466
PMCID:
PMC4733402
DOI:
10.1016/j.jand.2015.07.016
[Indexed for MEDLINE]
Free PMC Article

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