Rationale, design, and sample characteristics of a practical randomized trial to assess a weight loss intervention for low-income women: The Weight-Wise II Program

Carmen D. Samuel-Hodge, Beverly A. Garcia, Larry F. Johnston, Jennifer L. Kraschnewski, Alison A. Gustafson, Arnita F. Norwood, Russell E. Glasgow, Alison D. Gold, John W. Graham, Kelly R. Evenson, Sally C. Stearns, Ziya Gizlice, Thomas C. Keyserling

Research output: Contribution to journalArticlepeer-review

17 Scopus citations


Obesity is common among low-income mid-life women, yet most published weight loss studies have not focused on this population and have been highly resourced efficacy trials. Thus, practical type 2 translational studies are needed to evaluate weight loss interventions for low-income women. In this paper, we present the rationale, study design, and baseline characteristics of a type 2 translational study that evaluates both the processes and outcomes of a weight loss intervention for low-income women given at 6 county health departments in North Carolina. Key features of this study include random selection of study sites, intervention delivery by current staff at study sites, efforts to integrate the intervention with local community resources, a focus on evaluating the processes of translation using the RE-AIM framework, use of an evidence-based weight loss intervention, a detailed description of participant recruitment and representativeness, and a practical randomized trial designed to assess the effectiveness of the intervention. Of 81 health departments invited to participate, 30 (37%) were eligible and willing, and 6 were selected at random to deliver the intervention. Of 432 potential participants screened by phone, 213 (49%) were eligible and of these, 189 (89%) completed baseline measures and were randomized to receive a 5-month weight loss intervention or a delayed intervention. The mean age was 51, mean BMI 37kg/m 2, 53% were African American, and 43% had no health insurance. The results of this study should be informative to key stakeholders interested in real world weight loss interventions for low-income mid-life women.

Original languageEnglish
Pages (from-to)93-103
Number of pages11
JournalContemporary Clinical Trials
Issue number1
StatePublished - Jan 2012

Bibliographical note

Funding Information:
This study was supported through funding by the Centers for Disease Control and Prevention (CDC) grant no. 5R18DP001144. Other support was provided by the University of North Carolina Prevention Research Center (Center for Health Promotion and Disease Prevention) through funding by CDC cooperative agreement no. U48/DP000059. Dr. Kraschnewski was supported by the Health Resources and Services Administration through a National Research Service Award Primary Care Research Fellowship (5T32 PE14001-20). These funding sources had no involvement with the preparation of this manuscript or the decision to submit for publication. Dr. Glasgow is now with the National Cancer Institute (NCI). This paper does not necessarily reflect the opinions of the NCI.


  • Health departments
  • Low-income
  • Mid-life women
  • Obesity
  • Practical randomized trial
  • Translational research
  • Weight loss

ASJC Scopus subject areas

  • Pharmacology (medical)


Dive into the research topics of 'Rationale, design, and sample characteristics of a practical randomized trial to assess a weight loss intervention for low-income women: The Weight-Wise II Program'. Together they form a unique fingerprint.

Cite this