Background
Intensive dietary intervention programs may lead to benefits in vitality and other components of health quality. The Women’s Health Initiative (WHI) 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, depressive symptoms, cognitive functioning, and sleep quality.
Design
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, medical conditions with predicted survival less than three 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
RAND 36-Item Health Survey was used to assess HRQoL at baseline, year 1, and close-out (about 8 years post randomization), and estimate differential HRQoL subscale change scores.
Statistical analysis performed
Mean change in HRQoL scores (year 1 minus baseline) were compared by randomization group using linear models.
Results
At one year, there was a differential change between intervention and comparison group of 1.7 units (1.5, 2.0) in general health associated with the intervention. DM intervention improved physical functioning by 2.0 units (1.7, 2.3), vitality by 1.9 units (1.6, 2.2), and global QOL by 0.09 units (0.07, 0.12). With the exception of global QOL, these effects were significantly modified by BMI at baseline.
Conclusions
DM intervention was associated with small, but significant improvements in three health related quality of life subscales: general health, physical functioning, and vitality at one year follow-up, with the largest improvements seen in the women with the greatest baseline BMI.