title: 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.
  
  
  METHODS
  This randomized controlled trial was analyzed as intent to treat.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors.forename: Annlouise R
authors.initials: AR
authors.lastname: Assaf
authors.forename: Shirley A A
authors.initials: SAA
authors.lastname: Beresford
authors.forename: Patricia Markham
authors.initials: PM
authors.lastname: Risica
authors.forename: Aaron
authors.initials: A
authors.lastname: Aragaki
authors.forename: Robert L
authors.initials: RL
authors.lastname: Brunner
authors.forename: Deborah J
authors.initials: DJ
authors.lastname: Bowen
authors.forename: Michelle
authors.initials: M
authors.lastname: Naughton
authors.forename: Milagros C
authors.initials: MC
authors.lastname: Rosal
authors.forename: Linda
authors.initials: L
authors.lastname: Snetselaar
authors.forename: Nanette
authors.initials: N
authors.lastname: Wenger
mesh_terms: D000368:Aged; D015992:Body Mass Index; D003072:Cognition Disorders / Q000209:etiology / Q000517:prevention & control; D060825:Cognitive Dysfunction / Q000209:etiology / Q000517:prevention & control*; D003863:Depression / Q000209:etiology / Q000517:prevention & control; D018752:Diet, Fat-Restricted / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006304:Health Status; D006801:Humans; D057194:Intention to Treat Analysis; D053609:Lethargy / Q000209:etiology / Q000517:prevention & control*; D008875:Middle Aged; D018673:Nutrition Policy; D050177:Overweight / Q000178:diet therapy / Q000503:physiopathology; D010349:Patient Compliance; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D057566:Self Report; D012893:Sleep Wake Disorders / Q000209:etiology / Q000517:prevention & control; D014481:United States; D015431:Weight Loss
keywords: Body mass index; Dietary intervention; Health-related-quality of life; Postmenopausal; Randomized controlled trial