Randomized trial of a clinic-based, community-supported, lifestyle intervention to improve physical activity and diet:: The North Carolina enhanced WISEWOMAN project

Objective. To determine if a clinic-based behavioral intervention program for low-income mid-life women that emphasizes use of community resources will increase moderate intensity physical activity (PA) and improve dietary intake. Methods. Randomized trial conducted from May 2003 to December 2004 at one community health center in Wilmington, NC. A total of 236 women, ages 40-64, were randomized to receive an Enhanced Intervention (EI) or Minimal Intervention (MI). The El consisted of an intensive phase (6 months) including 2 individual counseling sessions, 3 group sessions, and 3 phone calls from a peer counselor followed by a maintenance phase (6 months) including I individual counseling session and 7 monthly peer counselor calls. Both phases included efforts to increase participants' use of community resources that promote positive lifestyle change. The MI consisted of a one-time mailing of pamphlets on diet and PA. Outcomes, measured at 6 and 12 months, included the comparison of moderate intensity PA between study groups as assessed by accelerometer (primary outcome) and questionnaire, and dietary intake assessed by questionnaire and serum carotenoids (6 months only). Results. For accelerometer outcomes, follow-up was 75% at 6 months and 73% at 12 months. Though moderate intensity PA increased in the El and decreased in the MI, the difference between groups was not statistically significant (p = 0.45; multivariate model, p = 0.08); however, moderate intensity PA assessed by questionnaire (92% follow-up at 6 months and 75% at 12 months) was greater in the El (p=0.01; multivariate model, p=0.001). For dietary outcomes, follow-up was 90% for questionnaire and 92% for serum carotenoids at 6 months and 74% for questionnaire at 12 months. Dietary intake improved more in the El compared to the MI (questionnaire at 6 and 12 months, p<0.001; serum carotenoid index, p = 0.05; multivariate model, p = 0.03). Conclusion. The El did not improve objectively measured PA, but was associated with improved self-reported and objective measures of dietary intake. Clinical trials registration. clinicaltrials.gov identifier: NCT00288327. (C) 2008 Elsevier Inc. All rights reserved.